Endotoxins are remnants of bacterial cell walls that may contaminate drug products and cause an immunogenic response. They are often referred to as “pyrogens†due to their fever-inducing effects. Endotoxins may be found in drug products either due to contamination from host cells used to produce a drug product in a bacterial expression system or due to adventitious bacterial contamination in non-microbial products. Thus, endotoxin clearance is a requirement of downstream processing of biologics, especially those derived from microbial expression…
Author Archives: BPI Contributor
Finesse Solutions Opens Branch Office in South Korea
Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life science process applications, has enhanced its business operations in Asia by opening a branch office in Seoul, South Korea. Finesse Korea joins other offices already established in Asia – in Singapore and Shanghai – to support the rapidly expanding Asia market. “The bioprocessing industry in Korea is one of the fastest growing in the world,†said Dr. Barbara Paldus, CEO and co-founder of Finesse Solutions. “Korea is poised…
MilliporeSigma Relaunches Customer Collaboration Centers with New Concept and M Labâ„¢ Name
MilliporeSigma today is relaunching its global network of customer collaboration centers, providing customers a shared, exploratory environment with scientists and engineers working to solve their toughest biomanufacturing challenges, helping accelerate development of new therapies. Formerly known as biomanufacturing science training centers, the new state-of-the art M Labâ„¢ concept will include a simulated manufacturing environment that provides customers a setting that fosters education and full end-to-end process development support. The centers are created especially for customer collaboration in which problem solving for…
Sartorius Acquires US Start-Up ViroCyt
Sartorius, a leading international pharmaceutical and laboratory tools provider, today announced the acquisition of ViroCyt Incorporated, an innovator in the field of rapid virus quantification. Based in Broomfield, Colorado, USA, the start-up is expected to achieve high double-digit growth and to generate more than $3 million sales revenues in 2016 while achieving break even underlying EBITDA by the end of 2018. The transaction values ViroCyt at approx. $16 million. ViroCyt’s main customers come from pharma and biopharma R&D laboratories, vaccine…
MilliporeSigma Advances Water Purification Systems with New High-Throughput Line
MilliporeSigma today introduced the Elix® High-Throughput water purification system, providing laboratories with a reliable water purification solution for daily water volumes of up to 9000 liters. Designed to operate at the heart of a central water purification solution, the Elix® High-Throughput system offers full connectivity, providing authorized users real-time remote monitoring via computer, tablet or smartphone with access to all important water quality data. “MilliporeSigma is committed to improving laboratory workflows with innovative products like our Elix® line of water…
MilliporeSigma Expands Excipients Portfolio, Adding Polymers for Sustained Release Injectables
MilliporeSigma has entered into an agreement with PCAS S.A. (Longjumeau, France) to expand MilliporeSigma’s excipients portfolio. Under the agreement, MilliporeSigma will be the exclusive, global distributor of the Expansorb® line of biocompatible and biodegradable polymers. The portfolio will include 38 polymers for sustained release of small molecule and selected peptide injectables, allowing customers to optimize and precisely control release kinetics of final drug products. The ability to better control and sustain the release of drugs allows for delivery via reduced…
Qosina Introduces New Barbed Check Valves
Qosina is pleased to announce the addition of eight new barbed check valves to complement their extensive line of stock components. Available in three different configurations, these barbed valves have a low, 0.087 psi cracking pressure. The barb to barb straight and reducing configurations (#80500 – #80503) accommodate 1/8 inch (0.125 inch, 3.2 mm) and 3/32 inch (0.093 inch, 2.4 mm) ID tubes and are made of MABS and silicone. The female luer lock to barb and the barb to…
Svec and Pesek Honored by CASSS for Service to Biopharmaceutical Community
CASSS, a professional biopharmaceutical society, honored longtime volunteers Frantisek Svec and Joseph Pesek as Distinguished Fellows after their retirements from the CASSS Board of Directors. At a recent luncheon, John Frenz, president of the CASSS Board, noted that Svec had “shepherded CASSS into a big evolution” that developed CASSS into a global community of biopharmaceutical professionals. Svec, the former facility director of the organic and macromolecular synthesis facility at E.O. Lawrence Berkeley Laboratory, served on the CASSS Board for more…
Sartorius Stedim Biotech Acquires U.S. Start-Up kSep Systems
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, today has signed a contract to acquire U.S. centrifuge specialist kSep Holdings, Inc. (kSep). The privately owned company based in Morrisville, NC, has been operating on the market since 2011, and is expected to achieve significant double-digit growth and to generate around $7 million sales revenues and a strong double-digit EBITDA margin in 2016. The transaction values kSep at around $28 million and will be closed by the…
Eppendorf Expands Single-Use Vessel Portfolio for Microbial Fermentation
Eppendorf expands its portfolio of rigid-wall single-use vessels for fermentation. The newly launched Eppendorf BioBLU® 3f was developed specifically for microbial bioprocessing in working volumes of 1.25 to 3.75 L, extending the full range of operation for single-use fermentation from 60 mL to 3.75 L. Eppendorf BioBLU f Single-Use Vessels specifically address the demands of high cell density fermentation of bacteria, yeasts, and fungi. Robust magnetic overhead drives featuring Rushton-type impellers support agitation rates up to 1200 rpm and provide…