Author Archives: BPI Contributor

OPUS PD

Effective Deployment of OPUS Pre-Packed Chromatography Columns for Bench-Scale Process Development and Process Validation

This webcast features: Tim Schroeder, Director, Product Management at Repligen GmbH Formerly Atoll pre-packed columns, OPUS® pre-packed chromatography columns for process development are used in all steps of downstream development, including screening, process validation and viral clearance, scale up and sample preparation. This webcast will demonstrate how OPUS® ValiChrom Columns, glass pre-packed columns that are exact scale-down models of corresponding full-scale chromatography columns, are ideal for process validation including viral clearance. It will also demonstrate how OPUS® RoboColumns®, miniaturized columns…

MilliporeSigma Expands End-to-End Biodevelopment Centers in North America, China and Europe

MilliporeSigma, a leading science and technology company, today announced the expansion of its end-to-end biodevelopment centers to meet increasing customer demand for its turnkey portfolio of bioprocessing products, manufacturing capabilities and industry leading technological expertise. The expansion, which includes the opening of two new process development centers in the U.S. and China, follows the commercial success of MilliporeSigma’s biodevelopment center in Martillac, France. The two new units will be located in close proximity to customers in the Shanghai and Boston…

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Qosina Adds New Y Connector Hemostasis Valves

Qosina is pleased to announce the addition of four new Y connector hemostasis valves (#80300-#80303) to its product line. Each hemostasis valve is equipped with a rotating male luer lock or male luer slip, and a female luer lock sideport. The Y connector gives the valve an ergonomic design for comfortable handling. The housing is made from a tinted polycarbonate material that minimizes discoloration during the sterilization process. The silicone gasket creates a seal for secure positioning when closed and…

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Characterization and Engineering Performance of the Allegro™ STR 2000 Single-Use Stirred Tank Bioreactor

Process performance in bioreactors is strongly influenced by the efficiency of bulk fluid mixing and the oxygen mass transfer coefficient (kLa). The success of traditional stainless steel STR systems lies in their direct impeller driven agitation that can deliver a wide range of specific power inputs to the fluid. The Allegro™ range of single-use stirred tank bioreactors has adopted this direct driven impeller technology, which allows a wide range of specific power inputs to be achieved. In addition, modifications to…

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Ultimate Flexibility from Pre-Packed to Unpacked: OPUS 45R and OPUS 60R Columns

This webcast features: Fletcher Malcom, Director of Product Management, Repligen With an innovative side port that allows for easy resin unpacking, OPUS® 45R and OPUS® 60R Columns provide the ultimate flexibility in pre-packed column technology. Without compromising chromatographic performance or cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in CGMP settings, and allows for re-use of the unpacked resin in other columns. This webinar covers test results on chromatographic performance, bioburden testing, shipping tests and simple…

Photo Members of the China SFDA tour the BTEC facility. (www.btec.ncsu.edu)

Saint-Gobain Opens New Maryland Facility to Manufacture Single-Use Systems for Cell Therapy

Saint-Gobain Performance Plastics’ Life Sciences Division is celebrating its move into the fast-growing cell therapy market with a new state-of-the-art facility that will manufacture specialty disposables for both the cell therapy and biotechnology markets. With material technology combined with expertise in custom design, Saint-Gobain Performance Plastics is uniquely positioned to offer solutions to the numerous challenges faced by cell therapy manufacturers today, contributing to the end goal of delivering effective therapies to more patients. Located in Gaithersburg, Maryland, the new…

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Enabling Custom Solutions for Downstream Processing for Future Therapies: AAV Case Study

This webcast features: Orjana Terova, Purification Product Manager, Thermo Fisher Scientific There is a need in the industry for a standard purification strategy for the manufacture of novel molecules including viral vectors and oligomeric therapies. Working with customers, Thermo Fisher Scientific has developed innovative purification resins through the POROS™ custom resin program and CaptureSelect™ ligand technology. This combination of ligand and resin development has allowed for development of platform purification processes that increase productivity and improve product yield for gene therapies.…

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The Standardization of Single-use Components for Bioprocessing

As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology. This paper discusses standardization in…

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Challenges of Scale Up and Development of Insect Cell Culture and BEVS

This webcast features: Sharyn Farnsworth, Associate Principal Scientist, FUJIFILM Diosynth Biotechnologies A strategy for scale up and implementation of Insect Cell Culture (ICC) should be assessed at the earliest stages of process development as there are a different set of challenges in the culture of ICC and BEVS versus a CHO culture and a limited number of vendors experienced enough to guide you through the adventure of manufacturing ICC. Each system has a unique problem set ranging from which cell…

Lonza to Divest Peptides Business and Operations in Braine-l’Alleud, Belgium, to PolyPeptide

Lonza and the PolyPeptide Group jointly announced today that PolyPeptide Laboratories Holding (PPL) has entered into a definitive agreement with Lonza Sales AG and Lonza AG (both 100% affiliates of Lonza Group AG) to acquire the peptides business and operations of Lonza in Braine-l’Alleud, Belgium. Lonza’s Braine facility, with approximately 280 employees, is the center for peptide chemical development and manufacturing within Lonza. The agreement is expected to close in the next weeks, subject to customary closing conditions. The acquisition…