Manufacturing

Expression of Recombinant Antibody Fragments: High-Density Fermentation in Multiuse and Single-Use Systems

by , , , and

Single-use fermentors (SUFs) offer dramatic advantages over traditional stainless-steel clean-in-place (CIP)/sterilization-in-place (SIP) fermentors. Single-use technology eliminates the need for steam, chemicals, and water to clean and sterilize stainless vessels, which provides a direct reduction in capital cost and environmental-impact mitigation. Single-use platforms also increase equipment and process flexibility significantly, making it possible to switch campaigns from one product to another in minimal time, while eliminating cleaning and associated validation steps (1). Both Cytiva and Thermo Fisher Scientific offer SUFs that…

February 9, 2022

Lymphocyte Activation Gene 3 in Immunooncology: A Soluble Protein Alternative

by

Early in 2021 at the American Society of Clinical Oncology’s (ASCO’s) annual meeting, attendees witnessed the first validation of a novel checkpoint target: lymphocyte activation gene 3 (LAG-3). Bristol Myers Squibb’s (BMS’s) recent success in a phase 3 study of the relatlimab anti-LAG-3 monoclonal antibody (MAb) proved that the combination of LAG-3 and programmed cell death protein 1 (PD-1) is more effective than the standard of care in first-line metastatic melanoma (1). For about seven years, that standard has been…

February 9, 2022

In Search of a CMO for My Biotechnology Startup: How to Navigate a Journey Without Process Maps

by and

An innovative biopharmaceutical product can transform from an abstract idea at small scale into the basis of a burgeoning startup company. At that point, company leaders seek ways to ensure that a biologic will scale up in a quality-controlled, professional, and sustainable environment. That involves refining a research-stage prototype into a product that will be consistent and reproducible for research and development (R&D) and manufacturing and that will meet all relevant regulatory standards in specified target markets. Within the constraints…

February 4, 2022

Analyzing Single-Use Polymers for Cell Culture Processes: Comparison of Cell Growth and Viability Test Procedures

by , , , , and

The acceptance and implementation of single-use systems (SUS) or “disposables†has increased strongly in bioprocess development and biopharmaceutical manufacturing over the past two decades. Typically, suppliers provide SUS presterilized and ready to use. Using SUS eliminates time-consuming and expensive cleaning procedures (which often require corrosive chemicals and a large amounts of water) and removes the need to perform cleaning validation between batches. The application of SUS reduces the risk of product cross-contamination and increases product and patient safety (1–5). Polypropylene…

February 4, 2022

Establishing a Digital Platform for Data Science Applications in Biopharmaceutical Manufacturing

by , and

Biopharmaceutical manufacturing consists of multiple processes with complex unit operations. Those include mammalian cell culture in upstream operations and downstream chromatography steps for removing impurities from production streams and purifying the therapeutic biological molecule (1). Biomanufacturers need enhanced understanding to ensure the process control and manufacture of safe and efficacious drug products. Process understanding also enables opportunities for improving manufacturing efficiency. Both process understanding and optimization can be facilitated by leveraging large volumes of biotechnology data — typically generated during…

February 4, 2022

Facilitating Workforce Development: A case study on improving single-use training through vendor and end-user collaboration

by and

Discover how Pall Corporation and Lonza collaborated to improve single-use technology training for operators using a blended approach to learning. This article presents: The importance of SUT training for operators. Why a blended approach ensures that operators get the training they need in the format that best suits their learning style. How collaboration between suppliers and biomanufacturers can shorten training program development timelines and increase the quality of training tools. How Pall and Lonza developed a digital training approach together.…

January 27, 2022

eBook: Antibody–Drug Conjugates —
A New Generation of Approaches Is Changing the Game

by , , and

Combining large proteins with linkers and cytotoxins, antibody–drug conjugates (ADCs) may be the most complex drug molecules in development today. Despite early promise and product approvals, a number of technical concerns arose during product and process development. Characterizing and ensuring consistency in the number of small molecules that attach to the antibody — as well as ensuring their proper attachment and biophysics — all present significant challenges to ADC developers. Solving early problems associated with product quality has introduced a…

January 26, 2022

Chromatography in mRNA Production Workflow

by and

Rapid response to global pandemics requires the manufacture of billions of vaccine doses within months. This short timeline must allow for design and testing of active ingredients, development of production and purification processes, clinical evaluations, regulatory filings, and manufacturing. Existing purification methods often have been adopted from laboratory-scale techniques to allow rapid implementation, and those have provided adequate product quality. But future mRNA development will require optimized production and purification processes. Chromatography has been a workhorse of biomanufacturing for decades,…

December 22, 2021

Protecting Artificial Intelligence Inventions in Drug Development

by , , and

Artificial intelligence (AI) is a lot more sophisticated today than it was just a few years ago. Its impacts are felt outside of technology applications such as computing, malware, and natural language processing. For example, Google’s AI (called DeepMind) recently solved one of biology’s greatest problems: It determined a protein’s three-dimensional shape from its amino acid sequence. Now, AI is making a foray into drug development processes. Drug development is a risky, expensive, time-consuming, yet often lucrative venture. The costs…

December 16, 2021

Working with Big Data in Healthcare and Bioprocessing Settings: A Brief Introduction to Key Components and Considerations

by , , and

Artificial intelligence (AI) in healthcare and biopharmaceutical industries still is in early stages of development and use, yet proper data management is critical to successful implementation at any stage of the enterprise continuum. AI is applied to help researchers understand and analyze biology, diagnose diseases, design new drugs, and predict clinical potential and treatment outcomes. AI has been applied in the discovery and development of novel drugs and for repurposing existing drugs, manufacturing different types of drug products, and optimizing…

December 15, 2021