Author Archives: BPI Contributor

Bioprocessing Challenges and CMO Opportunities in China

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This webcast features: Scott Wheelwright, PhD, Co-Founder and Principal, Complya Asia China’s biopharmaceutical manufacturing is significantly increasing, among domestic and international companies. Contract manufacturing services as well as those with potential to do so are rapidly changing as well. In Part 4 of our series, Dr. Scott Wheelwright, Co-Founder and Principal, Complya Asia, will provide an overview of factors affecting manufacturing, manufacturing trends by market, biopharmaceutical manufacturing in China among CMOs and developing companies. Watch the recorded webcast below.

November 2, 2019

Systems Compliance: A Risk-Based Approach to Software Management

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This webcast features: Martin Laferriere, Director, IT Systems Compliance, Avid Bioservices Software systems risk management and evaluations should be part of your validation process. It is possible to reduce testing by documenting your risk, actual use, regulation impact, evaluating vendor(s), etc. The approach to managing the risk evolves through audits and prior experience and can tailor the management and approach to system quality within each organizations. In my experience and observations, an efficient system risk management is essential, and it…

November 1, 2019

BioContinuum™ Buffer Delivery Platform

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Streamline your buffer preparation and management through an integrated combination of an automated buffer dilution system, high-quality buffer concentrates, single-use assemblies, and a tailored service package.

October 31, 2019

Single-Use Technologies: Accelerating Bioprocess Design with Key Insights from the Experts

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Companies turn more and more to single-use technologies (SUTs) to mitigate production challenges — and with good reason. SUTs clearly decrease conventional costs while increasing process integrity. Yet as the writers in this compilation suggest, SUTs are now making possible new, exciting ways to configure, operate, and evaluate biomanufacturing. In this compilation, BioProcess International gathers key insights from biopharmaceutical industry experts at Sartorius Stedim Biotech to explore how SUTs can realize high-quality yet cost-effective end-to-end bioprocessing. The studies herein identify…

October 29, 2019

Ask the Expert: Clarification of Lentiviral Vectors Using Scalable Filtration

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Researchers traditionally have produced lentivirus (LV) in adherent cultures by transient transfection using media containing animal serum. The method is inexpensive for process development (PD) and early clinical trials, but it requires increased operator manipulations and costs during scale-up. Development scientist Adam McLeod delivered an Ask the Expert webinar on 27 August 2019 to illustrate how GE Healthcare Life Sciences at the Centre for Advanced Therapeutic Cell Technologies (CATCT) in Toronto, Canada, approaches lentiviral vector (LVV) manufacturing. McLeod explained that…

October 23, 2019

Ask the Expert: Automated, Closed-Loop, Inline Monitoring of CAR T Cells in a Production Process

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Jan Van Hauwermeiren (vice president of sales and marketing at Ovizio Imaging Systems) joined BPI for an Ask the Expert webinar on 29 August 2019. He demonstrated how his company’s iLine F microscopy system combines sensitive optical capability with machine learning to monitor chimeric antigen receptor (CAR) T-cell expansion, transduction, and activation. The device captures holographic images of cells as they pass through a single-use conduit running between a microscope and bioreactor. Cells then funnel back into culture without additional…

October 23, 2019

New Features for Single-Use Pumps in Biopharmaceutical Manufacturing

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Everybody has heard the axiom “time is money,†which highlights the belief that time is a valuable resource; therefore, it is better to do things as quickly as possible in order to make more money. This concept perfectly describes the current atmosphere within the biopharmaceutical industry, where drug manufacturers are struggling to overcome speed-to-market challenges in order to reap the financial benefits of an optimized patent window. In order to bring their products to market, most biopharmaceutical-manufacturing systems employ a…

October 22, 2019

Using Slope Spectroscopy for Faster, Repeatable, More Accurate Protein Concentration Measurements

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This webcast features: Joe Ferraiolo, Bioanalytics Applications Manager, Repligen Traditional capture chromatography titer measurements that involve dilution requirements represent the highest single source of error in traditional UV analysis. Slope spectroscopy requires no sample preparation or dilution, saving substantial time without changing any other aspects of the assay. This webinar will demonstrate how variable pathlength slope spectroscopy using the SoloVPE™ device can significantly reduce sample prep and process time, while maintaining high repeatability and accuracy. Watch the recorded webcast below.

October 16, 2019

Highly Sensitive Host Cell Protein Analysis Using µPAC™ LC-MS

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This webcast features: Dr. Koen Sandra, Scientific Director, Research Institute for Chromatography, and Geert Van Raemdonck, Global Field Support Expert, PharmaFluidics Within a rapidly growing biopharmaceutical market, there is an increasing demand for the development of a rising number of biotherapeutic protein drugs, such as monoclonal antibodies (MAbs). During the development and production of biotherapeutic proteins, typically using mammalian cell lines, such as Chinese hamster ovary (CHO) cells, additional proteins are expressed as well by the host cell. These so-called…

October 14, 2019

Cell Culture Media Analysis Using a Handheld Raman Analyzer with Onboard Chemometrics

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This webcast features: Orville Dean Stuart, Technical Regional Sales Manager, Thermo Fisher Scientific This webinar presents the use of a handheld Raman analyzer with onboard chemometrics to verify the identify and monitor the quality and batch-to-batch variability of both dry powder chemically defined media and ready-to use liquid cell culture media. While scans of cell culture media using Thermo Scientific’s TruScan RM handheld Raman analyzer produce spectra with good Raman features, due to similar constituents and formulations, the TruTools add-on…

October 9, 2019