2018

Product Development Through Commercial Production: Guiding Your Biologic from Start to Finish

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Eunyoung Yang, team leader and chief development officer of the business development team, Samsung BioLogics Samsung is maximizing customer satisfaction by providing customized, cost-effective, and comprehensive development and manufacturing services. It is the number-four company in the world worth, US$92.3 billion, with 672 offices in 91 countries and employing 512,000 people. Samsung provides electronics (its most well-known business), engineering and construction for heavy industries, financial services, and healthcare support including biologics manufacturing, a medical center, and electronic medical devices. Samsung…

August 21, 2018

The Perks and Pitfalls of a Single-Use Biopharmaceutical Facility

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Sun Ra Bullins, director of manufacturing, Avid Bioservices Avid Bioservices is a dedicated commercial contract development and manufacturing organization (CDMO) with over 13 years of commercial manufacturing experience. It received six CMO leadership awards in 2018. Avid has a new state-of-the-art facility (2016) in Myford, CA, which has been designed for fully disposable manufacturing with up to 2,000-L capacity; and a legacy commercial facility with stainless steel bioreactors up to 1,000 L in Franklin, CA. In designing the Myford facility,…

August 21, 2018

CMO Fusion: Where Stainless Steel Meets Disposable Technology

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Molly McGlaughlin, director of strategy and business development, BioVectra  Jim Stout, director of process science, BioVectra   McGlaughlin introduced BioVectra. The company has been in business for 45 years and is based in Canada. Its a well-established contract development and manufacturing organization (CDMO) and fine-chemical manufacturer, and is a subsidiary of Mallinckrodt Pharmaceuticals. BioVectra started out as diagnostic reagent company and now has a complementary set of niche capabilities. From 10 years of fermentation experience, it was a logical progression to…

August 21, 2018

BioProcess Insider Interviews at the BPI Theater @ BIO 2018 – Mass Bio and Bioasis

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At the BPI Theater @ BIO, editor Dan Stanton conducted a series of interviews live on stage to report on the latest movements in the biomanufacturing industry to start each busy day of dealmaking in Boston. Below are the videos from conversations with David Lucchino, chairman, Mass Bio; and Mark Day, president and chief executive officer, Bioasis. Massachusetts: Secrets to Success Lucchino explains that when you have a set of companies in an area, it lays the groundwork for growth…

August 20, 2018

eBook: Biopharmaceutical Training – Train Your Team to Meet Evolving Industry Needs

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Welcome to this year’s focus on industry training programs. In the past three years we’ve brought this information to you in several forms: as a full supplement issue (2016), a featured report (2017) – and now this ebook. Each program that we’ve profiled offers its unique approach to training present and future biotechnologists. The best of the programs offer hands-on training with current equipment provided by supplier partners and with up-to-date approaches to documentation and regulatory requirements. Many university- and…

August 10, 2018

Assurance of Clonality: Next-Generation Single-Cell Dispensing in Cell Line Development and Single-Cell Genomics

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At the Cell Line Development and Engineering (CLD&E) conference(23–25 April 2018, Amsterdam), Jonas Schöndube, CEO of cytena GmbH, gave a presentation highlighting some of the company’s recent developments in single-cell dispensing for documented clonal cell lines. About cytena cytena is a young company dedicated to the development and manufacture of tools for the biopharmaceutical industry. In 2015, cytena launched the single-cell printer™ (scp™), which enables fully automated isolation of single cells into 96- and 384-well plates. The patented technology uses…

August 8, 2018

eBook: Manufacturing CAR-T Cell Therapies — Insights and Challenges

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The rapid evolution and clinical success of T-cell immunotherapies is an exciting advance in the war on cancer. This treatment modality uses engineered cells from a patient’s own immune system to target and destroy cancerous cells. Chimeric antigen receptor T-cell (CAR-T) therapy is emerging as the most studied treatment in T-cell immunotherapy and is the basis for many ongoing clinical trials. FDA approval of the first two CAR-T therapies in 2017 provides a regulatory development framework, but optimization of CAR-T…

June 27, 2018

Accelerating Intensified Bioprocesses with High-Throughput Small-Scale Tools

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While many biopharmaceutical companies are exploring paths toward continuous processing, many tools already exist for implementing process intensification. As the authors of this special report illustrate, hybrid continuous processes that benefit from single-use technologies along with continuing improvements in perfusion cell culture already now are enabling improvements in cost reduction and accelerating time to market. And novel high-throughput and automated small-scale systems are helping development scientists gather more information in less time than before, reduce their development footprints, and make…

June 26, 2018

Oxygen Mass Transfer Correlation for a Rocking-Motion Bioreactor System

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Disposable bioreactor systems are technologies commonly used in bioprocessing. They provide cost-effective contamination control and allow more flexible facility layouts than do stainless steel alternatives. One of the most popular types of single-use bioreactors uses a rocking platform in place of a traditional shaft and agitator assembly to aerate and mix cell culture material within a presterilized, single-use plastic bag (1). The system studied here is the ReadyToProcess WAVE 25 bioreactor (GE Healthcare Life Sciences). In contrast to conventional stirred…

June 23, 2018

Demonstrating Scalable T-Cell Expansion in Stirred-Tank Bioreactors

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Emerging cell therapies have excited the pharmaceutical industry because they indicate potential new pathways to treat some of the most life-threatening diseases. T-cell therapies currently are the flagship technology in cell therapy with recent US FDA approvals of Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) treatments. Those therapies and others still in development use peripheral blood isolated lymphocytes (PBLs) modified with chimeric antigen receptors (CARs) or modified T-cell receptors (TCRs) to trigger the innate cytotoxic response of these immune…

June 23, 2018