Author Archives: BPI Staff

May Supplement Spotlight

World Vaccine Congress Names “Best CMO†At its annual meeting in Washington, DC, this past March, the World Vaccine Congress named Paragon Bioservices, Inc., as the “Best Contract Manufacturing Organization†(CMO) for 2016. The annual Vaccine Industry Excellence (ViE) Awards honor the industry’s most outstanding achievements in vaccine development around the world. This award is based on the service range in niche and core therapeutic areas, methods of performance improvement, attention to and quality of relationships with clients, reaching milestones…

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Niche Disease: Autoimmune/Noninfectious Uveitis Uveitis is the inflammation of the uvea, the pigmented layer that lies between the eye’s inner retina and its outer fibrous layer composed of the sclera and cornea. The most frequent etiologies are autoimmune diseases such as Behçet disease. Noninfectious intermediate and posterior uveitis (NIU) represents 10–15% of uveitis cases, making it the fourth leading cause of blindness in the developed world. About one in 4,500 patients suffer with this condition. Uveitis typically has been treated…

MilliporeSigma Expands Production Know-how to Deliver Full End-to-End Solution for Biopharma Industry

MilliporeSigma today announced the expansion of its state-of-the-art single use current good manufacturing process (cGMP) facility with the addition of the Mobius® 2000L single-use bioreactor. With the new upstream suite at its Biodevelopment Center in France, MilliporeSigma can now offer clients full process line cGMP manufacturing, comprised of MilliporeSigma’s own instrumentation and products. “Our aim is to facilitate accelerated drug development and delivery via continued innovation and technical expertise by offering customers a complete end-to-end solution from clone to commercial production,”…

New MilliporeSigma Products Bring Ease of Use to Single-Use

MilliporeSigma is launching three Mobius® products that deliver improved efficiency and ease-of-use for biopharmaceutical manufacturing workflows. The new Mobius® products include a 1000-liter single-use bioreactor with an industry-leading design, a 2000-liter mixing system for difficult-to-mix biopharm ingredients and a large volume liquid transport system for aseptic and non-aseptic substances. “Our newest Mobius® products meet our customers’ increasingly complex demands for user friendly systems that allow them to focus on their science,” said Udit Batra, CEO, MilliporeSigma. The Mobius® 1000 liter single-use bioreactor completes the…

MilliporeSigma Introduces First Multi-use Disposable Sterile Connectors for Biopharma at INTERPHEX 2016

MilliporeSigma today announced the launch of its first-in-class  Lynx® CDR connectors to improve fluid management in the biopharma industry. The Lynx® CDR connectors debut at the International Pharmaceutical Expo (INTERPHEX) event in New York, New York, April 26-28. “Lynx® CDR connectors will change the way pharmaceutical fluids are managed, lowering drug manufacturing costs,” said Udit Batra, CEO, MilliporeSigma. “Our connectors set a new standard for sterile fluid connections, dramatically improving ease of use and reliability.” Making simple, reliable, sterile-to-sterile fluid connections is critical…

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Preventing Vaccine Shortages Few people worry about vaccine supply until a shortage occurs. New research from Duke University’s Fuqua School of Business focuses on market tensions that can keep vaccine manufacturers out of the business and price points needed to entice them in. “The government doesn’t want to overpay,†says professor David Ridley, “but there’s a tension between responsible use of government funds and giving manufacturers sufficient incentives to get into vaccine manufacturing — and stay in.†Together with colleagues…

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Introducing a New Editorial Advisor Nanda Subbarao is a senior consultant with the Biologics Consulting Group specializing in analytical, stability, and quality systems for chemistry, manufacturing, and controls (CMC) with good laboratory and manufacturing compliance (GLPs, GMPs). She has assisted pharmaceutical and biotechnology organizations in evaluation of analytical methods and method validation for a broad range of products ranging from conventional drugs to well-characterized proteins and vaccines, from preclinical to commercial phases. Subbarao has been involved several times over her…

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Niche Disease: Soft-Tissue Sarcoma (STS) by Cheryl Scott Cancer comes in two forms: the more common carcinoma form (of epithelial origin) and the less common sarcoma form. Sarcoma cells are mesenchymal in origin. Soft-tissue sarcomas are cancers of tissues such as fat, muscle, nerves, tendons, the lining of joints, blood vessels, or lymph vessels. Because there are at least 50 different types of STS, it is more accurately described as a family of related diseases rather than a single disease.…

WuXi Biologics Signs On As Premier Sponsor of the 2016 BioProcess International Awards

BioProcess International (BPI), a business-to-business publication dedicated to delivering cutting-edge information focused on the development and manufacture of biopharmaceuticals and therapeutics, announces an agreement with WuXi Biologics to become a premier sponsor of the 2016 BioProcess International Awards – Recognizing Excellence in the People, Organizations and Technology Applications in Bioprocessing. The BPI Awards has been developed to encourage the leaders, scientists, manufacturers, and suppliers to raise the awareness of their individual achievements, collaborations, successful business strategies, social corporate responsibility and…

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Niche Disease: CAPS by Cheryl Scott Cryopyrin-associated periodic syndromes (CAPS) are rare, inherited, autoinflammatory diseases with similar genetics and overlapping symptoms. The group includes three subtypes: familial cold autoinflammatory syndrome (FCAS); Muckle-Wells syndrome (MWS); and neonatal-onset multisystem inflammatory disease (NOMID), also called chronic infantile neurologic cutaneous articular (CINCA) syndrome. The cryopyrin protein is critical to production of the inflammatory cytokine interleukin-1β (IL-1β), which triggers inflammatory response when it binds to inflammatory cells. Genetic alterations in cryopyrin cause IL-1β overproduction, resulting…