BPI White Papers

Future Immunoassay Approaches in Modern Bioprocess Development

Modern bioprocess development requires accurate, high throughput analytical methods to match scaled-down, high-throughput screening, the application of DoE, and science-based decision making consistent with QbD. Gyrolab™ systems and Gyros’ immunoassay kits constitute a proven platform that supports these needs today and has the capability to meet future challenges. The assay principle uses high-capacity, flow-through affinity columns embedded within a CD. Centrifugal force, capillary action and hydrophobic barriers are exploited during parallel processing of up to 112 samples on each CD.…

Applying Single-Use Efficiencies to Room-to-Room Fluid Transfer

Biopharma manufacturers need to transfer critical fluids from cleanroom to cleanroom quickly, aseptically, and with minimal effort and expense for maximum productivity. Traditional hard piping involves intensive cleaning operations and down time between uses. Portable tanks run the risk of damage and leaks and also present cleaning challenges. Incorporating Single-Use components and practices with in-wall transfer systems can help speed and streamline operations while maintaining isolated environments. These types of systems help remove the risk of breakage, spillage and lost…

Robust, Load Independent Viral Clearance in Monoclonal Antibody Purification

Anion exchange chromatography is an important flow-through polishing step for viral clearance of monoclonal antibodies. Resin based materials are most commonly used for this but the large size of virus particles limits diffusion and binding capacity. It is therefore necessary to use large volumes of resin and oversized column hardware. Column chromatography as a unit operation also means high operational costs, including validation, cleaning and storage. This is a particular issue for clinical manufacturing, where a column is used for…

Development and Optimization of CHOgro® Transient Expression Technologies for High Titer Antibody Production in Suspension CHO Cells

During early stage drug development, quickly obtaining relevant candidate proteins through transient transfection can accelerate drug discovery. High titers are often obtained from Human Embryonic Kidney (HEK) 293 derived cell types; however, the use of different host cells between early stage transient and later stable protein production is a concern and can lead to the advancement of false-positive candidates. Chinese hamster ovary (CHO) cells are a desirable target cell type due to growth characteristics and a history of regulatory approval;…

Increased Monoclonal Antibody Resolution with TSKgel® UP-SW3000 Columns

The antibody therapeutics market is enjoying high growth rates, the major areas of therapeutic application being cancer and immune/inflammation-related disorders including arthritis and multiple sclerosis. In 2013, six of the top ten best-selling global drug brands were monoclonal antibodies (mAbs) and more than 400 mAbs were in clinical trials. The characterization of these complex biomolecules is a major challenge in process monitoring and quality control. The main product characteristics to be monitored are aggregate and fragment content, glycosylation pattern and…

Characterization of Subvisible Particles in Vaccine Development

Vaccine manufacturers want meaningful information that can be linked to process knowledge to increase product quality and eliminate patient safety issues. New requirements from the United States Pharmacopeial Convention (USP) and the U.S. Food and Drug Administration (FDA) put pressure for root cause analysis to understand impact on changes during process and product development. The new demands involve not only size and distribution but deeper characterization that involves morphology and composition studies as part of particle characterization. Nanoparticles like virus,…

Your Reliable Contract Manufacturing Solution Partner in China

This whitepaper focuses on Boehringer Ingelheim’s development and manufacturing facility in China. As one of the world’s leading organizations in the area of biopharmaceutical contract manufacturing, Boehringer Ingelheim is the first multi-national pharmaceutical company that brings over 30 years of experience in biopharmaceutical contract manufacturing to China, to better serve patients and the biopharmaceutical industry – both in China and in the world. As a pioneer in biopharmaceuticals with more than 35 years of experience the company has brought more…

How Molded Manifold Assemblies Prevent Leaks & Costly Consequences

Molded tubing manifolds have roles to perform over and above being a transport vehicle for liquids. The assemblies must maintain leak-proof flow. They need to meet sterility requirements and help limit the need for cleaning and associated validations. They also must be cost effective, simple to use and efficient. When compared with hand-assembled tubing sets, the advantages of molded tubing manifold assemblies are clear. Tubing sets made from multiple components present a risk of leaks at every juncture. With barbed…

Development of a Novel Cold-Chain Tubing, FP-FLEX™, and Single-Use Freezing Bag: For Working Cell Banks Enabling Closed-System Processing to Temperatures As Low As –196 °C

Working cell banks (WCBs) are commonly applied to initiate cell culture manufacturing campaigns to produce therapeutic proteins. Those campaigns typically begin with the inoculation of cells previously cryopreserved in vials. Although vials are typically used to establish WCBs and initiate manufacturing campaigns, they are not optimal for the growing demands of commercial production.

ThawSTAR™ Automated Cell-Thawing System: Breakthrough Adaptive Sensing Technology for Reproducible, Standardized Cell Thawing

Advances in cryopreservation techniques have been crucial for the substantial progress achieved in many fields, including cell biology research, drug discovery, bio-banking, and assisted reproduction. While cryopreservation techniques have markedly improved, downstream cell thawing techniques have thus far been neglected, even though proper thawing of cryopreserved materials is essential for optimal cell viability. The success of high-promise fields such as cellular therapy and regenerative medicine require reproducible and standardized handling of the therapeutic cells, which includes thawing both during manufacturing…