BPI White Papers

Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control

The analytical group at Boehringer Ingelheim, Fremont, USA needed a robust assay to measure the biological activity of an antibody fragment (Fab) molecule for in-process testing as well as stability and lot release testing in their Quality Control (QC) department. The developed Fab activity assay is accurate and robust, with intermediate and intramediate precision less than 10%. Drug activity measurement using the Octet¬ģ system has become a critical parameter for their product evaluation and has resulted in increased Fab drug…

Security of Supply Risk Mitigation in HCP Monitoring

The most common method scientists use to monitor host cell protein (HCP) levels in biologics is the enzyme-linked immunosorbent assay (ELISA). For the reagent, security of supply is a regulatory requirement ‚Ā†‚ÄĒ it‚Äôs a factor that‚Äôs critical to consistently monitoring HCP during biologic production. In this webinar, we discuss why security of supply is important, the consequences of not having it, and how to mitigate this risk. Topics covered Why security of supply is critical to your HCP plans Consequences…

The Production and Application of Antibody Fragments

Antibodies are modular defense systems that identify and neutralize foreign objects like bacteria and viruses. In addition to oncology and inflammation, antibodies are now recognized as routine molecules in many therapeutic fields. Antibody fragments, in particular the Fabs, scFvs and VHH retain full antigen-binding capacity and superior properties for research, diagnostic and therapeutic applications. They have a smaller size that enables their binding to hidden epitopes not accessible to whole antibodies. In the context of therapeutic applications, a small molecular…

Protecting Protein Stability with a Novel Grade of Sucrose

Ensuring the chemical and physical stability of the therapeutic protein is critical to the safety and efficacy of biopharmaceuticals and presents one of the major challenges in formulation. A number of excipients, including sugars, can be used to solve this problem. Sugars are stabilizers that maintain conformational stability by preferential exclusion and function as cryo- and lyoprotectors in lyophilized formulations. Given these properties, it is not surprising that sucrose is one of the most widely used stabilizers in marketed drug…

Human Umbilical Cord-derived Mesenchymal Stem Cell Production in Corning¬ģ HYPERStack¬ģ 36-layer Cell Culture Vessels

As more clinical trials are evaluating MSC-based therapies, the demand for more pertinent adherent scale-up tools is likely to increase. Corning¬ģ HYPERStack¬ģ 36-layer cell culture vessels offer a closed system solution for scaling up large quantities of quality, human umbilical cord-derived MSCs. Most importantly, the MSCs expanded in the HYPERStack 36-layer vessel expressed high percentages of CD90, CD105, and CD73, characteristic of MSC quality. The ability to grow large quantities of human umbilical cord derived MSCs with high viability and…

Whitepaper: Intensifying Upstream Processing – Implications for Media Management

Process intensification offers many benefits but implementing PI can introduce an unexpected challenge of managing larger media volumes. This whitepaper helps ensure your implementation strategy accounts for the increased media volume associated with process intensification. What You Will Learn Gain the tools and knowledge needed to confidently assess intensification options with a focus on media management for new or existing facilities. Follow the media journey from prep to use, exploring potential logistical pitfalls in the management of increased media volumes…

A Frost & Sullivan Virtual Think Tank: 3M™ Polisher ST Beta Testing Series

One step can change everything: Replace your flow-through AEX column with a novel single-use polishing solution 3M™ Polisher ST single use polishing solution – from lab to manufacturing scale Frost & Sullivan recently invited a panel of bioprocessing industry leaders and key opinion leaders to participate in a Virtual Think Tank (VTT) Early Access series ‚Äď a new and unique thought leadership forum. Each VTT panel, comprised of professionals from top pharmaceutical companies, contract development and manufacturing organizations (CDMOs) and…

Build vs. Buy: A Critical Calculation for Cell Therapy Innovators

Cell therapy is proving to be one of the most promising advanced modalities, representing a significant step forward in the treatment of a wide range of challenging diseases and conditions. As a cell therapy candidate advances from discovery through clinical development and ultimately to commercialization, foundational decisions must be made by the product sponsor that will impact both scientific and commercial success. One of the biggest decisions is whether to build a manufacturing facility or outsource to a contract development…

Five Ways the Amersham ImageQuant™ 800 GxP Helps You Remain Compliant

In highly regulated environments, such as the pharmaceutical industry, remaining GxP compliant while efficiently delivering your products to a competitive market is a challenging task, particularly when Western blot imaging is involved. While this can often be a tricky and time-consuming task, our Amersham ImageQuant™ 800 GxP imaging system and software streamlines the process. It provides simple solutions that support data traceability, accountability, and integrity. Confident decision making and GxP compliance go hand in hand with high-quality imaging. In this…

3M™ Polisher ST ‚ÄĒ The Next Frontier in Downstream Processing, a Frost & Sullivan White Paper

Advancements in next-generation therapies‚ÄĒPaving the way for novel bioprocessing solutions. Learn about 3M Polisher ST technology which utilizes a guanidinium-functionalized polyamide membrane protected by a Q functionalized non-woven material. This Frost & Sullivan whitepaper explains how the technology demonstrates the viability of replacing the depth filtration and anion exchange chromatography (AEX) steps to achieve a simplified and cost-effective process. The platform is designed to reduce process and product related impurities and offer robust performance across a wide range of process…