Newsletter | March 28, 2024

03.28.24 -- Meet "MAM," The New Quality Control Strategy On the Block

FEATURED EDITORIAL

Shocking! Biotech Facilities Don't Maintain Themselves

Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.

Navigating China's Biologics Approval And Accelerated Pathways

Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.

Getting To Know MAM, The New Quality Control Strategy On the Block

When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.

A Structured Approach To Regulatory Information Management Vendor Selection

Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

INDUSTRY INSIGHTS

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill/finish process.

Elastomer Plungers With Barrier Film For COVID-19 Vaccines

Minimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.

NEWS HEADLINES

Dr. Reddy's Laboratories Launches Versavo (bevacizumab) In The UK

Biosimilars Forum Announces Support For Increasing Access To Biosimilars Act

SOLUTIONS

Mabion Capacity Update February 2024: Large Molecule

A Dedicated Team To Safely Store Your Cell And Virus Banks