Author Archives: BPI Contributor

Ten important lessons the cell and gene therapy industry can take from the bioprocessing industry

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It’s time to tackle the challenges of sustainable and cost-effective commercial manufacturing regarding cell and gene therapy. Cell and gene therapies have many of the same manufacturing needs as biopharmaceuticals. As a result, industry experts expect single-use technologies used in biopharmaceutical clinical trials and commercial production to play a larger role in the future development and production of cell and gene therapy. Single-use systems are already incorporated in the development of cell and gene therapies today. However, many of those…

November 20, 2019

Closed, Single-Use TFF Assembly Makes Performance-Leading TangenX Cassette Technologies Even Easier to Use

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This webcast features: Michael LaBreck, Global Bioprocess Sales Specialist, TangenX™ TFF Products, Repligen Corporation SIUS-Gamma TFF cassettes incorporate the performance-leading TangenX™ TFF membrane and cassette manufacturing technologies into a closed, gamma-irradiated, single-use assembly. Genderless, aseptic connections easily integrate into your current UF/DF flow path, and a library of 64 MWCO and surface area configurations provide rich process options. The closed format, leading TFF performance (flux, selectivity, reproducibility) of the TangenX membrane and manufacturing innovations that enabled the first single-use by…

November 19, 2019

Asahi Kasei Bioprocess’ Planova SU-VFC: Realizing Single-Use Technology in Virus Filtration

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This webcast features: Brian Crawford, Director of Operations, Asahi Kasei Bioprocess America, Inc. By eliminating the need for clean-in-place, reducing demands on quality control, and optimizing product changeover times, single-use systems offer great benefit at pilot, clinical, and commercial production scales. The new Planova™ Single-Use Virus Filtration Controller (SU-VFC) from Asahi Kasei Bioprocess America, Inc. offers the hallmark consistency of Planova™ filters in a compact, fully automated single-use form factor with full 21 CFR Part 11 compliance for greater efficiency…

November 19, 2019
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Discover Capsugel Dry-Powder Inhalation Capsule Portfolio

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This webcast features: Claire Tardy, PhD, Research & Development Manager, Capsule Delivery Solutions, Lonza Pharma & Biotech Dry-powder inhalation (DPI) is a major drug delivery technology for the treatment of respiratory diseases and increasingly for systemic drug delivery. Providing a uniform dose in a portable, easy-to-use system, capsule-based DPI is a simple and cost-effective way to deliver medication via the pulmonary route. Within dry-powder inhalation application fields, Lonza offers the Capsugel® Zephyr™ Dry-Powder Inhalation portfolio: high-quality capsule solutions based on…

November 15, 2019

Aseptic Filling for Gene Therapies and Next-Generation Biologics Within Closed Robotic Workcells

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This webcast features: Thomas Page, PhD, Vice President, Engineering and Asset Development, FUJIFILM Diosynth Biotechnologies Fujifilm Diosynth Biotechnologies (FDB) sought to “close the loop†by keeping all upstream and downstream aseptic processing operations within closed systems. The missing part was downstream, where FDB implemented a closed robotic filling workcell for manufacturing gene therapies. Workcells solve long-standing problems with sterility assurance, containment, and process control in aseptic filling. The knowledge developed by FDB during its implementation and early use of a…

November 13, 2019

Accelerating Timelines by Integrating Cell Line Development and Manufacturing Programs

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This webcast features: Nicole Wakes, Group Leader, Cell Line Development, Abzena The start of cell line development represents a significant milestone for biologics innovators: It’s a commitment to a specific molecule and the start of the journey towards IND. By using the latest technologies such as automated multiple microscale bioreactors and high-throughput analytics, it is possible to interrogate clones more closely to determine productivity, manufacturability, and performance at scale and at an early stage. In addition, the data generated can…

November 12, 2019

Implementation of Single-Use Fermentation Technology

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This webcast features: Andrew Lowell, Associate Director, Upstream Process Development, KBI Biopharma, Inc. KBI Biopharma, Inc. has implemented single-use fermentation (SUF) systems that have allowed greater throughput and efficiency in the laboratory, leading to accelerated project timelines to good manufacturing practice (GMP) production. The single-use fermentation systems address those programs with relatively small material needs while decreasing validation requirements and increasing operational efficiencies. Coupling process design with the SUF equipment capabilities has enabled processes capable of high cell densities and…

November 12, 2019

Accelerating Development and Manufacturing Platforms for Viral Vectors

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This webcast features: Bai-wei Gu, Head of the Cell Line Development Group, WuXi Advanced Therapies Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. In this webinar, we will discuss our recent technical advancements in efficient viral vector manufacturing process development. From cell line development, to suspension culture of HEK293 cells, to media optimization and purification process, a series of improvements were implemented to advance our platform development for scalable large-scale manufacturing of viral…

November 8, 2019

Efficient Solutions for the Purification of Challenging Antibody Formats

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This webcast features: Laurens Sierkstra, Senior Director, Business Leader, Purification, Thermo Fisher Scientific Inc., Bioproduction Leiden/Naarden, The Netherlands The changing landscape for antibody-derived therapeutics, such as bispecific monoclonal antibodies, Fab fragments, and Fc-fusion proteins brings new purification challenges in the downstream process of these molecules. Standard chromatography resins, such as Protein A, may not result in the most efficient process. Thermo Scientific™ CaptureSelect™ resins, focusing on alternative antibody domains, enhance the success of your antibody purification process. From research to…

November 5, 2019

China’s Emergence in Global Biopharma Manufacturing: Trends in the Chinese Biopharma Industry

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This four-part educational series, sponsored by BioProcess International and BioPlan Associates, Inc., highlights key trends emerging in China biopharmaceuticals, using select content BioPlan Associates’ 2018 2nd edition report, Advances in Biopharmaceutical Technology in China, 2nd Ed. The quarterly series, each consisting of articles, an e-book, 40-min webcast, and live presentation at select BPI Events cover China’s Emergence in Global Biopharma Manufacturing: Trends in Chinese Biopharma Industry. The projects include an Overview, Developments in Biologics, Biosimilars, and Global Expansion. The series…

November 5, 2019