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life cycle.
PHARMTECH TALK
The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
MANUFACTURING, TOPICAL DRUGS Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.SMALL-MOLECULE APIS
August 09, 2020. By Pharmaceutical Technology Editors. Citing undisclosed allegations against Kodak, the DFC placed a hold on apotential $765
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. FABOHIO | PHARMA MARKETPLACE | PHARMACEUTICAL TECHNOLOGY FabOhio opened for business in 1963 and continues to operate at the same facility in Uhrichsville, Ohio today. The core business is the same as when we started up – engineering flexible synthetic films for use as barrier isolation in many forms and applications.CELSUS LABS
Celsus Labs. Celsus Laboratories, Inc., a wholly-owned subsidiary company located in Cincinnati, is a USDA-approved, FDA-registered drug establishment that manufactures bulk-lyophilized heparin sodium of porcine tissue and various derivatives thereof. Celsus Biopharmaceuticals, Inc, a wholly-owned subsidiary company, wasfounded in 1995 to
PHARMTECHWEBCASTSMARKETPLACESPOTLIGHTTOPICNEWSPUBLICATIONS Biogen and Capsigen to Develop Novel AAV Capsids for up to $1.37 Billion. May 12, 2021. Biogen and Capsigen have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system and neuromuscular disorders. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMTECH TALK
The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
MANUFACTURING, TOPICAL DRUGS Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.SMALL-MOLECULE APIS
August 09, 2020. By Pharmaceutical Technology Editors. Citing undisclosed allegations against Kodak, the DFC placed a hold on apotential $765
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. FABOHIO | PHARMA MARKETPLACE | PHARMACEUTICAL TECHNOLOGY FabOhio opened for business in 1963 and continues to operate at the same facility in Uhrichsville, Ohio today. The core business is the same as when we started up – engineering flexible synthetic films for use as barrier isolation in many forms and applications.CELSUS LABS
Celsus Labs. Celsus Laboratories, Inc., a wholly-owned subsidiary company located in Cincinnati, is a USDA-approved, FDA-registered drug establishment that manufactures bulk-lyophilized heparin sodium of porcine tissue and various derivatives thereof. Celsus Biopharmaceuticals, Inc, a wholly-owned subsidiary company, wasfounded in 1995 to
EMA APPROVES NEW MANUFACTURING SITE FOR MODERNA COVID-19 1 day ago · The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing. The new site follows two other sites approved by CHMP in June for theINDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.PHARMTECH | PAGE 2
Lonza and Moderna to Expand Their COVID-19 Vaccine Drug Substance Manufacturing Collaboration. June 02, 2021. By Pharmaceutical Technology Editors. The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’sGeleen
EU REGULATORS RECOMMEND NOT RELEASING BATCHES OF JANSSEN 1 day ago · As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility. The European Medicines Agency (EMA)MANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive processTOPIC - PHARMTECH
2021 MJH Life Sciences and Pharmaceutical Technology. All rightsreserved.
FILL-FINISH
Fill-Finish. CONTINUE TO SITE. OR WAIT null SECS. Search. Spotlight. COVID-19 Update Analytics Dosage Forms Drug Development Manufacturing Outsourcing Quality Systems. Topic. View More Analytical Method Development APIs Aseptic Processing Biologic Drugs Drug Delivery Equipment Excipients Formulation Packaging Process Control/PAT ProcessPHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma. BRINTER SUCCESSFULLY CLOSES SEED FUNDING ROUND LED BY 1 day ago · Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor. Bioprinting start-up company, Brinter, has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early PHARMACEUTICAL TECHNOLOGY-05-15-2021 Eyeing Up Success in Fill/Finish. May 15, 2021. Operations. 2021 eBook. 2. Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.PHARMTECH
Hovione to Re-Join iBet. June 03, 2021. Hovione has re-joined iBET to increase its R&D programs in novel and high potential pharmaceutical technologies and to combine expertise for industrial innovation in newtherapeutic fields.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory.PHARMTECH
Hovione to Re-Join iBet. June 03, 2021. Hovione has re-joined iBET to increase its R&D programs in novel and high potential pharmaceutical technologies and to combine expertise for industrial innovation in newtherapeutic fields.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. EMA APPROVES NEW MANUFACTURING SITE FOR MODERNA COVID-19 21 hours ago · The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing. The new site follows two other sites approved by CHMP in June for theMANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive processDEVELOPMENT
Biogen and Capsigen to Develop Novel AAV Capsids for up to $1.37 Billion. May 12, 2021. Biogen and Capsigen have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system and neuromuscular disorders. EU REGULATORS RECOMMEND NOT RELEASING BATCHES OF JANSSEN 21 hours ago · As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility. The European Medicines Agency (EMA)TOPIC - PHARMTECH
2021 MJH Life Sciences and Pharmaceutical Technology. All rightsreserved.
FILL-FINISH
Fill-Finish. CONTINUE TO SITE. OR WAIT null SECS. Search. Spotlight. COVID-19 Update Analytics Dosage Forms Drug Development Manufacturing Outsourcing Quality Systems. Topic. View More Analytical Method Development APIs Aseptic Processing Biologic Drugs Drug Delivery Equipment Excipients Formulation Packaging Process Control/PAT ProcessOUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BRINTER SUCCESSFULLY CLOSES SEED FUNDING ROUND LED BY 1 day ago · Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor. Bioprinting start-up company, Brinter, has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early API SYNTHESIS AND MANUFACTURING, SMALL MOLECULE Lonza to Add New Small-Molecule Manufacturing Complex to Switzerland Site. April 26, 2021. By Pharmaceutical Technology Editors. Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide COMPANIES | PHARMA MARKETPLACE | PHARMACEUTICAL TECHNOLOGY BioPharma Solutions, a business unit of Baxter, collaborates with pharmaceutical companies to provide contract manufacturing Jost Chemical Co. For 30 years Jost Chemical Co. has manufactured high purity chemical salts for the pharmaceutical, biopharmaceutical, nutrition and AbbVie. AbbVie Contract Manufacturing has nearly 30years of
PHARMTECH
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development,and manufacturing.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory.PHARMTECH
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development,and manufacturing.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. EMA APPROVES NEW MANUFACTURING SITE FOR MODERNA COVID-19 7 hours ago · The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing. The new site follows two other sites approved by CHMP in June for the EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials arePHARMTECH | PAGE 2
Lonza and Moderna to Expand Their COVID-19 Vaccine Drug Substance Manufacturing Collaboration. June 02, 2021. By Pharmaceutical Technology Editors. The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’sGeleen
EU REGULATORS RECOMMEND NOT RELEASING BATCHES OF JANSSEN 7 hours ago · As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility. The European Medicines Agency (EMA)MANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive processTOPIC - PHARMTECH
2021 MJH Life Sciences and Pharmaceutical Technology. All rightsreserved.
FILL-FINISH
Fill-Finish. CONTINUE TO SITE. OR WAIT null SECS. Search. Spotlight. COVID-19 Update Analytics Dosage Forms Drug Development Manufacturing Outsourcing Quality Systems. Topic. View More Analytical Method Development APIs Aseptic Processing Biologic Drugs Drug Delivery Equipment Excipients Formulation Packaging Process Control/PAT ProcessOUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BRINTER SUCCESSFULLY CLOSES SEED FUNDING ROUND LED BY 16 hours ago · Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor. Bioprinting start-up company, Brinter, has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early COMPANIES | PHARMA MARKETPLACE | PHARMACEUTICAL TECHNOLOGY BioPharma Solutions, a business unit of Baxter, collaborates with pharmaceutical companies to provide contract manufacturing Jost Chemical Co. For 30 years Jost Chemical Co. has manufactured high purity chemical salts for the pharmaceutical, biopharmaceutical, nutrition and AbbVie. AbbVie Contract Manufacturing has nearly 30years of
PHARMTECH
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development,and manufacturing.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory.PHARMTECH
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development,and manufacturing.
INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
FORMULATION
Using Quality by Design to Develop Fixed-Dose Combination Tablets. June 02, 2021. In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using 23 factorial design.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BIOLOGICS APIS
Biologics Facilities Expand and Establish New Locations in 2021. May 14, 2021. The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceuticalspace.
SMITHERS AVANZA
Smithers Avanza is a contract research organization (CRO) supporting the pharmaceutical, agrochemical, and chemical industries. Our scientists have expertise in large molecule bioanalysis, assay development, validation and sample analysis at our GLP- and GCP-compliant and CLIA registered laboratory. EMA APPROVES NEW MANUFACTURING SITE FOR MODERNA COVID-19 5 hours ago · The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing. The new site follows two other sites approved by CHMP in June for the EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials arePHARMTECH | PAGE 2
Lonza and Moderna to Expand Their COVID-19 Vaccine Drug Substance Manufacturing Collaboration. June 02, 2021. By Pharmaceutical Technology Editors. The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’sGeleen
EU REGULATORS RECOMMEND NOT RELEASING BATCHES OF JANSSEN 5 hours ago · As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility. The European Medicines Agency (EMA)MANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive processTOPIC - PHARMTECH
2021 MJH Life Sciences and Pharmaceutical Technology. All rightsreserved.
FILL-FINISH
Fill-Finish. CONTINUE TO SITE. OR WAIT null SECS. Search. Spotlight. COVID-19 Update Analytics Dosage Forms Drug Development Manufacturing Outsourcing Quality Systems. Topic. View More Analytical Method Development APIs Aseptic Processing Biologic Drugs Drug Delivery Equipment Excipients Formulation Packaging Process Control/PAT ProcessOUTSOURCING
Developing a Method for Success through Partnerships. Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and developmenttime efficiencies.
BRINTER SUCCESSFULLY CLOSES SEED FUNDING ROUND LED BY 14 hours ago · Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor. Bioprinting start-up company, Brinter, has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early COMPANIES | PHARMA MARKETPLACE | PHARMACEUTICAL TECHNOLOGY BioPharma Solutions, a business unit of Baxter, collaborates with pharmaceutical companies to provide contract manufacturing Jost Chemical Co. For 30 years Jost Chemical Co. has manufactured high purity chemical salts for the pharmaceutical, biopharmaceutical, nutrition and AbbVie. AbbVie Contract Manufacturing has nearly 30years of
PHARMTECH
Supply Chain Hurdles for Vaccine Production. Materials availability is a factor in vaccine production. Spray-Dried Dispersion Formulation. In-vitro and in-silico tools can help predict in-vivo outcomes. Manufacturing Outside the Box. Intensified and distributed manufacturing approaches create flexible, local capacity.INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
MANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive processFORMULATION
Focusing on Accelerated Formulation Strategies. April 02, 2021. Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Risk assessment and careful planning are crucial for timely delivery. Demonstrating the Value of Collaboration. The rapid pace of drug development during the COVID-19 pandemic demonstrates the value of collaborations. Collaboration toward Commercialization. Innovators, contractors, and technology providers advance cell and gene therapies.BIOLOGICS APIS
This new collaboration between Vyant Bio, Ordaōs Bio, and Cellaria mitigates risk in the drug discovery process using artificial intelligence and in-vitro “avatar” clinical trials.PHARMTECH
Supply Chain Hurdles for Vaccine Production. Materials availability is a factor in vaccine production. Spray-Dried Dispersion Formulation. In-vitro and in-silico tools can help predict in-vivo outcomes. Manufacturing Outside the Box. Intensified and distributed manufacturing approaches create flexible, local capacity.INDUSTRY NEWS
Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation. May 26, 2021. FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are PHARMACEUTICAL TECHNOLOGY 2021 MJH Life Sciences ™ and . Pharmaceutical Technology. Allrights reserved.
PHARMACEUTICAL TECHNOLOGY-03-15-2021 A Real-World Approach to Evaluating Cleanroom Garments. March 15, 2021. Operations. 2021 eBook. 1. Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garmentlife cycle.
MANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive processFORMULATION
Focusing on Accelerated Formulation Strategies. April 02, 2021. Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.PHARMA INSIGHTS
Pharma Insights - Thought Leadership from Marketers | Sponsored Content. Lipoid GmbH. STERIS. Vetter Pharma.OUTSOURCING
Risk assessment and careful planning are crucial for timely delivery. Demonstrating the Value of Collaboration. The rapid pace of drug development during the COVID-19 pandemic demonstrates the value of collaborations. Collaboration toward Commercialization. Innovators, contractors, and technology providers advance cell and gene therapies.BIOLOGICS APIS
This new collaboration between Vyant Bio, Ordaōs Bio, and Cellaria mitigates risk in the drug discovery process using artificial intelligence and in-vitro “avatar” clinical trials. EQUIPMENT - PHARMTECH Bag Dump Module for Bulk Solid Equipment. May 02, 2021. Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials areTOPIC - PHARMTECH
2021 MJH Life Sciences and Pharmaceutical Technology. All rightsreserved.
MANUFACTURING
Annex 1 and Isolator Operation. Decontamination, automation, and containment are important considerations. Monitoring Downstream Processing in Real Time. Near-infrared spectroscopy demonstrates process analytical technology capabilities. Detecting Pharma Processing Fingerprints. Raman spectroscopy delivers real time, non-destructive process AGC BIOLOGICS TO SUPPLY MORE PLASMID DNA FOR PFIZER 22 hours ago · On June 7, 2021, AGC Biologics, a contract development and manufacturing organization (CDMO), announced that it has partnered with BioNTech to further supply plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine at AGC’s Heidelberg, Germany, facility. pDNA starting material is an essential component of BioNTech’s mRNA-based vaccine manufacturing process. FDA PUBLISHES GUIDANCE DOCUMENTS TO ENHANCE SUPPLY CHAIN 22 hours ago · FDA published guidance documents on June 3, 2021, that provide recommendations for complying with the Drug Supply Chain Security Act (DSCSA) in order to identify and trace drug products as they move through the supply chain. Two final guidance documents and two draft guidance documents were issued. Product Identifiers Under the Drug Supply Chain Security Act, Questions and PFIZER AND BIONTECH COVID-19 VACCINE AUTHORIZED IN UK AND 16 hours ago · The vaccine is now authorized for ages 12 and older in European Union member states and the UK. The United Kingdom’s Medicines and Healthcare products Regulatory Authority (MHRA) announced on June 4, 2021, that it was giving temporary authorizationof
CATALENT'S BIOAVAILABILITY AND DEVELOPMENT TOOLKIT OptiForm® Solution Suite is a fast, flexible, and fact-based screening platform, which works in combination with Catalent’s comprehensive bioavailability enhancing technology toolkit. From its network of development and manufacturing facilities, Catalent provides customers with end-to-end FDA APPROVES TREATMENT FOR PLASMINOGEN DEFICIENCY TYPE 1 22 hours ago · FDA announced on June 4, 2021, that it has approved Ryplazim (plasminogen, human-tmvh) to treat plasminogen deficiency type 1. Also known as hypoplasminogenemia, the rare disorder can impair tissue and organ function and may lead to blindness, according to the agency. Ryplazim was granted Orphan COMPANIES | PHARMA MARKETPLACE | PHARMACEUTICAL TECHNOLOGY BioPharma Solutions, a business unit of Baxter, collaborates with pharmaceutical companies to provide contract manufacturing Jost Chemical Co. For 30 years Jost Chemical Co. has manufactured high purity chemical salts for the pharmaceutical, biopharmaceutical, nutrition and AbbVie. AbbVie Contract Manufacturing has nearly 30years of
JANSSEN RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATION FOR 23 hours ago · The Janssen Pharmaceutical Companies of Johnson & Johnson announced on June 1, 2021 that FDA has granted breakthrough therapy designation for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody, for treating relapsed or refractorymultiple myeloma.
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