Author Archives: BPI Contributor

Filling Industry Gaps with Dedicated Cell Therapy Fluid Transfer Sets

For years, availability has cornered cell therapy manufacturers into utilizing transfer sets intended for other industries and applications. These transfer sets or accessory sets are not designed for cell therapy, and therefore lack key requirements, essential to clinical and commercial manufacturing. Many current personalized cell therapies are highly manual in practice, and require numerous ancillary components and handling steps. Modifications to these processes further complicate this inherently challenging process. These deviations impact the reproducibility of the manufacturing platform, as well…

Lonza and Selecta Biosciences Announce Manufacturing Agreement for Anc80-AAV-Based Gene Therapy for Treatment of Methylmalonic Acidemia

Lonza Houston, Inc., a global leader in viral gene and cell therapy manufacturing, and Selecta Biosciences, Inc., a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases that avoid unwanted immunogenicity, have entered into a strategic manufacturing agreement. Under the terms of the agreement, Lonza will produce an Anc80-AAV-based gene therapy product for Selecta’s proprietary program for the treatment of Methylmalonic Acidemia (MMA), a rare inborn error of metabolism, and may in the future produce other…

Almatec® Featuring BIOCOR Series Pumps at INTERPHEX 2017

Almatec®, part of PSG®, a Dover company and premier manufacturer of sanitary air-operated double-diaphragm (AODD) pumps, will be featuring its BIOCOR Series pumps for sterile applications in Booth 2253 at INTERPHEX 2017. The INTERPHEX event brings together a wide variety of leaders from the pharmaceutical and biotech industries and will be held at the Jacob K. Javits Convention Center in New York, NY, USA, from March 21-23. BIOCOR pumps from Almatec have been specifically designed for critical biotech and pharmaceutical…

Rentschler and Leukocare Announce Formulations Strategic Alliance and Equity Investment

Rentschler Biotechnologie GmbH, Laupheim and Leukocare AG, Martinsried today announced a strategic alliance under which Leukocare will become the specialized technology partner and the exclusive formulation developer for Rentschler’s biopharmaceuticals business. Rentschler in return will become the first and only contract development and manufacturing organization (CDMO) to have access to Leukocare´s patented SPS® formulation technologies. Leukocare’s ongoing and future business activities with pharma and biotech beyond the CDMO business will not be affected by this alliance. Rentschler will acquire a…

Servier Appoints MaSTherCell for the Development of its CAR-T Cell Therapy Manufacturing Platform

Servier, the independent international pharmaceutical company, and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, today announced the signing of a master service agreement for the development of a manufacturing platform for allogeneic cell therapies. Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier cell therapy products. This is a critical…

Improving Protein Folding Control and Scalability Using imPULSE Mixing Technology

This webcast features: Anthony Hawrylechko, Director of Microbial Bioprocess, Cytovance Protein folding by dilution is a common approach used in the manufacturing of biologics derived from microbial expression systems. This typically involves the solubilization of a washed inclusion body preparation containing the concentrated product polypeptide with a strong chaotrope or detergent solution. The denatured, inactive product solution is then diluted into a combination pH and red/ox buffer solution. Within this environment, the molecular diffusion rates of chaotrope, buffer components, and…

Continuous Processing Optimization With Smarter Tools

Single-use technology (SUT) has long been viewed as a viable solution to today’s biopharmaceutical manufacturing challenges. It offers the flexibility to change a production configuration to meet demand while also offering many other cost benefits, such as savings related to the elimination of clean-in-place (CIP) and sterilization-in-place (SIP) processes. However, traditional and fed-batch models fail when trying to adapt to single-use flexibility due to the required rewriting of code and revalidation. The best way to use the flexibility of single-use…

Vetter Starts Operations in its Center for Visual Inspection and Logistics

Vetter, a leading global Contract Development and Manufacturing Organization (CDMO) for development, aseptic filling and final packaging of injectables, has announced today that it has begun operations in its expanded Visual Inspection and Logics Center located in Ravensburg. The enlargement, in which the company invested approximately 100 million euros ($107 million), bundles capacity for final product inspection and logistics in one cutting-edge site. By finalizing the second construction stage of the site that was initially put into operation five years…

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 Launches First Commercial Service to Predict Multiple Sources of DNA Damage

MilliporeSigma has introduced CAN MultiFlow™ screening services to more accurately predict genotoxic and mode of action* properties of substances, ingredients and drug compounds. Offered through its BioReliance® testing facilities, MilliporeSigma will be the first company to provide this service in the United States. The screening process uses flow cytometry to quickly and efficiently screen for clastogens, aneugens and non-genotoxicants (CAN) in pharmaceutical compounds, agricultural chemicals, flavors, fragrances and consumer products. The results from the assay can help manufacturers reject harmful…