Wednesday, December 7, 2022 Daily Archives

Simple In-House Mycoplasma Testing Method for Regulatory Expectations and Rapid, Confident, and Actionable Results

Mycoplasma contamination is a risk to cell-based biologics manufacturing, potentially jeopardizing patient safety and product quality. Therefore, regulatory guidance globally requires manufactures to routinely employ a validated mycoplasma detection strategy for lot-release of their drug product. Beyond meeting regulatory expectations, the implementation of an in-house mycoplasma testing method is extremely valuable, providing companies with rapid, actionable data for both lot-release and raw materials testing, saving both time and money. The introduction of live mycoplasma or live mycoplasma cultures in production…

Solving Cost and Supply Challenges in Biopharma Downstream Processing

In only five years, the number of FDA approvals for monoclonal antibody (mAb) therapies has more than doubled. These therapies continue to lead resource investment as biopharmaceutical companies drive to get these innovative, life-changing therapies to market faster. Yet mAbs downstream processing — which accounts for roughly 60% of the production cost of a biologic drug — hasn’t kept up with advances in upstream processing. Much of this challenge stems from downstream processing’s need to move biological materials through a…

MilliporeSigma bolsters bioreactor offering with Erbi buy

The acquisition of Erbi Biosystems will enable MilliporeSigma to offer a full range of bioreactors ranging from 2 ml to 2,000 L, says firm.   MilliporeSigma – the life sciences division of Germany’s Merck KGaA – has acquired Massachusetts-based firm Erbi for an undisclosed fee. According to the bioprocess vendor and contract development and manufacturing organization (CDMO), Erbi’s 2 ml micro-bioreactor platform, Breez, will strengthen its upstream portfolio.  The Breez bioreactors operate by using miniaturized valves, filters, mixing, pumps, and sensors to perform…

Avid: Smaller player hesitancy contributes to a lumpy order book

Avid Bioservices attributed a lower order intake during its second quarter FY2023 to cash-strapped biotech but remains positive for the overall CDMO business as new capacity prepares to come online. For the quarter ending October 31, 2022, contract development and manufacturing organization (CDMO) Avid reported revenues of $34.8 million – an increase of 33% on the same period last year. The firm also announced the quarter clocked in at $26 million in net new project orders, considerably lower than the…