Newsletter | December 22, 2022

12.22.22 -- FDA Accepts Biogen BLA For Biosimilar Actemra

Featured Editorial

Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
		By Crystal M. Booth, PSC Biotech This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

5 Steps To Eliminate Weak Links In Your Data Governance
		By Patrick Middag and Dennie van de Voort, Deloitte Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how those data will be governed.

Industry Insights

De-Risking Biosimilar Development With A Clinically Validated And Commercially Proven Disposable Autoinjector

White Paper | By Victoria Meyer, BD Medical - Pharmaceutical Systems

Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

CDMO Collaboration: Foundation For Sterile Injectable Product Success

White Paper | Pfizer CentreOne

Explore how a small or midsize biotech or pharma company developing sterile injectables can benefit from the experience and assistance provided by a CDMO.

Capture Of Bispecific Antibodies And Removal Of Product-Related Impurities

Application Note | Cytiva

Many antibody variants are prone to aggregation or to forming product-related impurities. Explore the application of a resin with novel selectivity to purify challenging entities.

News Headlines

• FDA Accepts Biogen Biologics License Application For BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)

• Paras Biopharma Streamlines Offerings As ‘Biologics CDMO’ And Biosimilar Co-Development As ‘Paras Biologics’

• Fresenius Kabi Receives U.S. FDA Approval For Biosimilar Idacio (adalimumab)

• Cigna Offering Equal Access To New Biosimilars And Humira Next Year

• MiGenTra Highlights How Biosimilars Are Transforming Healthcare In Africa At The Festival Of Biologics

Solutions

Large Molecule Biologics Made With Intelligent Collaboration

Pfizer CentreOne

Life Science Leader Magazine


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