Manufacturing

AAV Vector Manufacturing Platform Selection and Product Development

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Adenoassociated virus (AAV) vectors have emerged as the prominent delivery mechanisms of corrective gene therapies. Three such products — Glybera (alipogene tiparvovec, uniQure), Luxturna (voretigene neparvovec-rzyl, Spark Therapeutics), and Zolgensma (onasemnogene abeparvovec-xioi, AveXis) — have been licensed, and a growing number of candidates are entering late-stage development. In mapping out an AAV gene therapy product development strategy, biomanufacturers should address fundamental considerations for their manufacturing strategies for both phase 1–2 clinical evaluation and translation for commercial market supply. A manufacturing…

December 16, 2019

The Road to Commercialization: A Commercial CDMO’s Perspective

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Richard Richieri, chief operation officer (COO) of Avid Bioservices, recently presented an Avid case study and strategy to design, prepare, and execute process validation in preparation for successful product approval inspections. The goals of the presentation were to share lessons about some of the strengths learned from Avid’s experience and to offer advice on industry best practices. Finding a CMO that meets your quality expectations and scale is a key driver for your eventual commercial success. Particularly, working with CMO…

December 10, 2019

Making Media a Priority: An Interview with Susan Riley of Advanced Bioprocessing

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Susan Riley is vice president and general manager of Advanced Bioprocessing. It’s been a year since Thermo Fisher Scientific’s acquisition of the Advanced Bioprocessing business from Becton Dickinson (BD). Why did Thermo Fisher see the Advanced Bioprocessing (AB) business as a good fit with its life-science offerings? AB has a significant portfolio in premium supplements for cell culture and microbial fermentation. The AB business was seen as a good fit for several reasons: It goes hand-in-glove with Gibco media, for…

December 4, 2019

Launch of the First Vaccine Bioprocess Training Program: A Standardized but Flexible Course to Boost the Global Vaccine Industry

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Based on the many forms that modern vaccines can take, their manufacturing is complicated. Unlike monoclonal antibodies (MAbs), vaccine manufacturers have no “template†platform to follow. Most vaccine producers develop their manufacturing processes from scratch, a prospect that can be challenging for small to mid-sized companies. Bioprocessing is the key challenge in vaccine manufacturing. Without a well-developed and understood process, a manufacturer will face serious challenges in commercial production: e.g., low yields, high costs, and difficulties in meeting quality standards.…

December 4, 2019

The Cell Therapy Industry Needs High-Quality Healthy-Donor Material

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The cell and gene therapy (CGT) segment has grown tremendously over the past decade. And while the industry deals with a steep learning curve inherent to a rapidly developing field, problems must be solved, and solutions must be reduced to practice. One such problem, long understood by the industry but now thrust into the spotlight, is sample handling: proper collection, processing, preservation, storage, and transportation of cellular starting material. Suboptimal techniques for such logistics have been shown not only to…

December 4, 2019

Bioprocess Intensification – Fast, Flexible, and Efficient Solutions

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Propelled by single-use systems (SUSs), biopharmaceutical companies are approaching the ideal of continuous bioprocessing. In addition to improving process integrity and decreasing production costs, SUSs have enabled exciting ways to configure, operate, and evaluate manufacturing steps. Sensitive process analytical technologies (PATs) and discriminating data analysis platforms are supplementing those developments, helping process engineers and operators to study and modify workflows in unprecedented ways. The goal now is to intensify: to apply increasingly nuanced process knowledge and growing technological capability in…

November 21, 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

eBook: Automation — The Value of Plug-and-Play Automation in Single-Use Technology

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The biopharmaceutical industry’s movement away from large-scale, fixed-tank facilities to flexible facilities featuring single-use technologies (SUTs) has demonstrated the value of modular equipment and agile process design. SUTs have proven to be clear advantages to end users because those technologies enable quick facility build and changeover times. But linking SUT equipment with equally flexible automative technology has been difficult. Herein a group of automation experts from the BioPhorum Operations Group (BPOG) elaborate “plug-and-play” principles and introduce a supervisory control system…

October 28, 2019

From Supplying Components to Providing Total Solutions: Overviewing Supplier Side Capabilities

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Only a thin line now separates biopharmaceutical manufacturers and suppliers because the latter are increasingly becoming the process knowledge owners in the biopharmaceutical industry. As a result, suppliers are racing to become the most efficient “total solutions†provider. In the 1990s, leading players in the industry such as Pall, Millipore, and Sartorius all supplied membrane filters for upstream and, to some extent, downstream processes with their crossflow and final filtration offerings. Pharmacia (which became GE Healthcare) was the major force…

October 28, 2019

Bioprinting Capabilities and Futures

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Bioprinting has advanced rapidly through engineering step changes in the use of three-dimensional (3D) printing. With these developments, living cells can be positioned layer by layer to produce functional tissue structures. Key attributes of this emerging technology are its high scalability and modularity, which enable automated and repeatable manufacture of a wide variety of tissues. These high-throughput biofabrication capabilities equip companies with tools to develop 3D-printed tissues for broad applications, from in vitro drug testing models to therapeutic tissue implants,…

October 28, 2019