Wednesday, October 5, 2022 Daily Archives

Comprehensive Solutions for Your Vaccine Platforms

You want to scale and deliver your vaccine to the world quickly. Our collaborative global vaccine capabilities will take your innovation from pre-clinical to full-scale GMP-manufacturing efficiently, safely, and cost-effectively. Our new handbook describes how our global capabilities can help you achieve these goals for all your modalities/platforms including inactivated/live attenuated vaccines, subunit vaccines, VLP vaccines, viral vector vaccines, pDNA vaccines, mRNA vaccines.

Flexibility in Next-Generation Facilities Through Rocking Motion Bioreactors

The biopharma industry continues to face increased demands for more efficient production processes and flexible solutions. Increasing efficiency in upstream bioprocesses leads to improvements in yield, speed, and cost-effectiveness. However, an often-overlooked feature of intensifying production processes is how they contribute to a more flexible and streamlined process, essential to meet the demands of this dynamic industry. What you will learn: Understand the issues creating operational challenges for the biopharma industry. Explore how an intensified seed train can increase upstream…

Leveraging Post-Translational Modifications and Bio-Functional Assays for Characterization of Charged Variants

This webcast features: Shawn Fitzgibbons, Senior Manager & Jacob Kraus, Manager, Biologics Analytical, Catalent. The heterogeneity of a biologic product has implications for the safety and efficacy of the final biotherapeutic or biosimilar therapy. It is important to characterize the charged variant profiles of biologics, since many important post-translational modifications (PTMs) impart or alter the charge (isoelectric point or pI) of the molecule, potentially impacting stability, pharmacokinetics, and pharmacodynamics. Examples of charged variants include lysine variants and deamidation products, both…

MilliporeSigma opens €50m France antibody production plant

The facility in Martillac will make commercial monoclonal antibody drug substance up to 2,000 L and is part of a wider MilliporeSigma investment in France. In June 2021, MilliporeSigma – the life sciences division of Germany’s Merck KGaA – announced plans to invest €175 million ($174 million) and create 500 jobs at its sites France. As part of that, a €50 million facility has opened its doors, adding a 2,700 square-meter single-use drug substance plant at the Martillac site, south…

Kite receives US FDA nod for California viral vector plant

The US FDA has approved Kite’s retroviral vector manufacturing plant in Oceanside, California for commercial production. According to Gilead company Kite Pharma, the authorization received from the US Food and Drug Administration (FDA) concerning its retroviral vector (RVV) facility in California supports its worldwide chimeric antigen receptor (CAR) T-cell therapy production network and helps meet demand of the firms’ blood cancer treatments. “With today’s approval, we’ll begin transitioning viral vector supply to our inhouse Oceanside manufacturing facility, while maintaining our…