Newsletter | December 8, 2022

12.08.22 -- Biocon Completes Acquisition Of Viatris Biosimilar Business
 
Featured Editorial
FDA Releases Guidance On Drug Products Containing Nanomaterials
 
By Tim Sandle, Ph.D.

The level of regulatory oversight required for these advancements has led to the FDA issuing a guidance for industry document. The guidance sets out the current challenges in nanomedicine development and the likely future directions in the field.
One Year Out, Where Do We Stand On DSCSA Implementation?
 
By Madeleine Giaquinto, J.D., Greenleaf Health

This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts before examining where implementation currently stands and what gaps and challenges remain.
Industry Insights
The Dynamic Regulatory Environment Of Drug-Device Combination Products
White Paper | By Diane Paskiet, West Pharmaceutical Services, Inc.

This white paper examines the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time-to-market.
COVID-19 Impact To Biological Drug Products Safety
Application Note | By A. Fun and S. Sheridan, MilliporeSigma Biosafety Testing Services

Review currently available literature, our recommended COVID-19 virus detection test methods, and susceptibility of common biological host cells to infection.
Generating A Robust Host Cell Line For A Cell Line Development Platform
Application Note | By M. Sabourin, P. Ravnikar, Z. Jiang, N. Lin, and P. Lio, Cytiva

Learn how cell performance within the context of the cell line development workflow was confirmed with the successful isolation of stable, high-producing clones from three model monoclonal antibodies.
Liposomal And Nanoparticle Technology At Pfizer Melbourne
White Paper | Pfizer CentreOne

Specializing in oncology, anti-infective, and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
Wearable Injectors: An Alternative To Traditional Intravenous Administration
Infographic | BD Medical - Pharmaceutical Systems

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.
News Headlines
Solutions
An Altogether Different Approach To Specialty API Supply
Pfizer CentreOne
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