ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics. The announcement, released in the Federal Register 72 (40) Docket 1999D-2013, relates to “cooperative manufacturing arrangements applicable to biological products licensure under section 351 of the US Public Health Service Act,” including short-supply, divided manufacturing, shared manufacturing, and contract manufacturing arrangements.
Primary topics covered in the document include reporting and recordkeeping responsibilities relating to these arrangements for the licensed manufacturer, the contract manufacturer, and the final-product manufacturer. Specifically, the draft guidance details the following:
Notification of any proposed change in the product, production process, quality controls or facilities
Notification of results of tests and investigations related to or impacting the product
Notification of products manufactured in a contract facility
Standard operating procedures.
The comment period for the draft guidance ends September 21, 2007.
Comment Period Open on Draft Guidance on Cooperative Manufacturing for Biologics
ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics. The announcement, released in the Federal Register 72 (40) Docket 1999D-2013, relates to “cooperative manufacturing arrangements applicable to biological products licensure under section 351 of the US Public Health Service Act,” including short-supply, divided manufacturing, shared manufacturing, and contract manufacturing arrangements.
Primary topics covered in the document include reporting and recordkeeping responsibilities relating to these arrangements for the licensed manufacturer, the contract manufacturer, and the final-product manufacturer. Specifically, the draft guidance details the following:
The comment period for the draft guidance ends September 21, 2007.
Abzena Expands Analytical Services with GMP Cell-Based Potency Testing in US and UK
The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Circio and Certest to Collaborate on LNP Formulations
The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.
Three New European Facilities Established by BioPharmaSpec for R&D
Located in German, Italy, and Lithuania, the new European facilities will specialize in drug discovery and R&D services.
CDMO SEKISUI Expands its CGMP Biopharma Manufacturing Capacity
SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.
Alentis Therapeutics to Advance Anti-Claudin-1 ADCs to Treat Solid Tumors on $181.4 Million Financing
Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.
Abzena Expands Analytical Services with GMP Cell-Based Potency Testing in US and UK
The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Circio and Certest to Collaborate on LNP Formulations
The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.
Three New European Facilities Established by BioPharmaSpec for R&D
Located in German, Italy, and Lithuania, the new European facilities will specialize in drug discovery and R&D services.
CDMO SEKISUI Expands its CGMP Biopharma Manufacturing Capacity
SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.
Alentis Therapeutics to Advance Anti-Claudin-1 ADCs to Treat Solid Tumors on $181.4 Million Financing
Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.