TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.
TAP Biosystems, now part of the Sartorius Stedim Biotech Group, a supplier of cell culture and fermentation systems for life science applications, announced that CMO Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.
Scientists at Gallus BioPharmaceuticals are using the ambr15 micro bioreactor in the company’s new, state-of-the-art process development facility in St. Louis, Missouri. The system is being used for clone selection programs to determine which CHO cell lines are stable and produce the highest titre mAbs. The scientists are also using the ambr system to optimize media selection and feed strategies for these mAbs, which are being developed as antibody therapeutics and biosimilars for some of the world’s top pharma and biotech firms.
Source: TAP Biosystems
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.