Prepping Fill/Finish Systems to Ensure Quality Output
A holistic approach to validation and quality assurance is essential.
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
Using Automated Inline Dilution to Ease Bottlenecking
Establishing an automated inline dilution system can potentially ease bottlenecking delays resulting from higher upstream yields.
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
Getting More Scientific About Cleaning Validation
The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.
What’s New in Lab Data Management Technologies
New advancements in lab data management technologies include devices with a fully integrated SDMS, a cloud-based and an online ELN, an ELN featuring a virtual assistant, and updated LIMS software.
Meeting the Challenges for Scaling Up Vaccine Manufacturing Systems
Scaling needs for potential COVID-19 vaccines depend not only on capacity, but also on supply chain challenges and technological hurdles.
Pandemic Brings Major Changes to FDA and Drug Development in 2020
Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.
Biopharma, People, Perseverance, and Hope
After a difficult year, biopharma science delivers promising results.
Impact of Pandemic on Permanent Procedures
Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
