Author Archives: BPI Contributor

Applying Single-Use Efficiencies to Room-to-Room Fluid Transfer

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Biopharma manufacturers need to transfer critical fluids from cleanroom to cleanroom quickly, aseptically, and with minimal effort and expense for maximum productivity. Traditional hard piping involves intensive cleaning operations and down time between uses. Portable tanks run the risk of damage and leaks and also present cleaning challenges. Incorporating Single-Use components and practices with in-wall transfer systems can help speed and streamline operations while maintaining isolated environments. These types of systems help remove the risk of breakage, spillage and lost…

March 2, 2016

Sartocon® Slice 50: A New Small-Scale Crossflow Device

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Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has launched the single- use ultrafilter Sartocon® Slice 50. The new crossflow filter device is designed for use in biotechnological applications, especially for membrane screening and small-volume process development. Sartocon® Slice 50 is offered as an encapsulated and ready-to-use crossflow module with a filter area of 50 cm2 and a wide variety of molecular weight cutoffs. The cGMP validated self-contained unit eliminates the need for a compression holder…

February 29, 2016

AdvantaPure® Introduces AdvantaFlex® Sterile Molded Tubing Ends

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Single-Use AdvantaFlex tubing with molded mini Tri-Clamp ends is now available from AdvantaPure. Offered in three tubing lengths, the assemblies are supplied gamma sterilized and are ideal for aseptic transfer and processing applications. AdvantaFlex Molded Tubing Ends work well in Single-Use applications by reducing operational costs and improving production efficiencies. They’re compatible with sterile tubing welders and available in a variety of tubing sizes and lengths for biopharma fluid transfer. The mini Tri-Clamp material – USP Class VI polypropylene –…

February 23, 2016

Proliant Biologicals Opens New Zealand Facility

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Proliant Biologicals is proud to announce the opening of its New Zealand Bovine Serum Albumin (BSA) manufacturing facility. The facility is located on the North Island of New Zealand, in Feilding. The facility was designed and constructed to replicate the “Closed Loop†system, developed and instituted in Proliant’s U.S. facility located in Boone, Iowa. The equipment design and installation was done to functionally duplicate the systems in the U.S. facility, with critical processing systems coming from the same vendors used…

February 13, 2016

Kodiak Sciences Inc. and Lonza Announce Agreements for the Development and Manufacture of Medicines for the Treatment of Retinal Disease

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Lonza, a global leader in biological and chemical manufacturing, and Kodiak Sciences Inc., a biopharmaceutical company designing and developing novel therapies for the treatment of retinal disease, announced today agreements for the clinical supply of Kodiak’s therapeutic candidates. Under the agreement, Lonza will manufacture material at multiple sites, including Slough (UK), Visp (CH) and Nansha (CN). Retinal diseases, such as age-related macular degeneration (AMD), cause blindness by damaging the retina, typically in those over 50 years of age. As the…

February 8, 2016

Gene Murano Announced as CASSS Hancock Award Winner for 2016

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CASSS has honored Genesio “Gene†Murano, PhD, principal/partner with Bioscope Associates, LLC, with its prestigious Hancock Award for Outstanding Achievements in CMC Regulatory Science. This annual award recognizes outstanding and sustained contributions in the field of regulatory science. Murano was announced as the 2016 honoree during CASSS’ 20th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (commonly referred to as WCBP), held in Washington, D.C., January 26 through 28. “The Hancock Award represents the dedication and commitment…

February 3, 2016

Lonza to Build Capabilities for Drug Product Development Services, Enabling One-Stop-Shop Solutions for Customers

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Lonza announced today that its Pharma&Biotech segment is expanding its footprint to offer customers a complete portfolio of development and manufacturing services for clinical outsourcing requirements by entering into Drug Product Services. This new service offering is part of Lonza’s drive to enable customers to meet some of the greatest challenges in patient treatment. These drug product services will focus on parenteral dosage forms, including products for injection and infusion for intravenous, subcutaneous, intraocular and other routes of parenteral administration.…

February 2, 2016

Goodwin Biotechnology Teams with Panacea Pharmaceuticals in Overcoming a Significant Bioconjugation Challenge for an Anti-Cancer Monoclonal Antibody

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Goodwin Biotechnology, Inc., a biological contract development and manufacturing organization (CDMO) that specializes in bioprocess development and CGMP manufacturing of biopharmaceuticals utilizing mammalian cell culture expression systems and bioconjugation technologies, was selected by Panacea Pharmaceuticals, Inc. to develop a proof-of-concept conjugation of a fully-human monoclonal antibody to a radionuclide chelator to generate an antibody-chelator conjugate. The conjugate is subsequently labeled with indium-111 (111In) and other potential radioisotopes for in vivo diagnostic imaging and treatment of cancers. “Panacea has developed a…

February 1, 2016

Pall Enters Supply Agreement with Kaneka for the Sale and Technical Support of KANEKA KanCapAâ„¢ Protein A Chromatography Sorbent

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Pall Corporation, a global leader in filtration, separation and purification, announced the signing of a supply agreement for KANEKA KanCapA, a leading Protein A (PrA) chromatography sorbent from Kaneka Corporation, Japan for the primary capture of monoclonal antibodies from clarified cell culture. KANEKA KanCapA enables the high productivity affinity capture of monoclonal antibodies and related biomolecules using a proprietary alkali stable rPrA ligand. The sorbent will be supplied in a range of pre-packed columns and high throughput screening tools, as…

January 29, 2016

Sartorius Stedim Biotech Launches Integrated Solutions Online Resource Center

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Sartorius Stedim Biotech, an international leading supplier for the biopharmaceutical industry, today announced the launch of its Integrated Solutions website, an online resource and information centre to support its clients as they develop and implement entire single-use or hybrid biomanufacturing processes. The new website is designed to assist clients in the implementation of flexible, scalable and cost-efficient bioprocesses by utilizing the tools, technologies, support and expertise available from Sartorius Stedim Biotech. To allow clients to better understand the effectiveness with…

January 26, 2016