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Eradicating the Need for Cold-Chain Distribution in the Biopharmaceutical Industry

Cold chain distribution is complicated and critical for formulations that must be kept in very cold temperatures in the pharmaceutical industry, since their stability decreases quickly at room temperatures. The World Health Organization (WHO) has reported over 50% of vaccines are wasted and must be disposed of globally every year due in part to disruption of the cold chain distribution and lack the resources to support the ultracold temperature requirements. A possible solution to the existing problem is Hyalo Technologies’…

The Five Heresies of Cell Culture: Debunking Conventional Wisdom

by Ian Sarad

Cell culture and bioprocessing conventional wisdom remains a hurdle for the wider adoption of more precise tools. It has been more than 60 years since any real progress has been made towards creating a more accurate and reliable way of performing cell culture monitoring to better understand the effects of things like pH and oxygen at the pericellular level. At SBI, we’re developing optical sensing technologies that unlock the “black box” of cell culture to bring actionable insights to scientists…

Cell-Line Development: Accelerating Antibody Discovery By Monitoring Titer and Glycosylation with the Octet Platform

by David Apiyo

Cell line development involves the screening of thousands of clones in an effort to find the few optimal clones that are stable, grow as expected, and produce high yields of the bioproduct. The time it takes from engineering an optimal cell line to the production of the target biologic can be prohibitive and may differ from molecule to molecule. While expression-level analysis like titer screening is carried out early, other critical quality attributes (CQAs) such as glycan characterization are often…

Measuring Cell Density in HyPerforma S.U.B.s with ABER Futura neo_tf
Single-Use Sensors

by Ben Madsen, Nephi Jones, Aditya Bhat and Rhys Jones

Monitoring critical process parameters (CPPs) and key performance indicators in bioreactor control systems is crucial to ensure proper cell growth and protein production. Today, most of the major biopharmaceutical companies employ capacitance measurement, in R&D and through process development to manufacturing. Owing to the increased use of single-use bioreactors and building on Aber’s experience with single-use capacitance sensors, the latest Futura neotf single-use capacitance sensors have been specifically developed for integration into Thermo Fisher Scientific bioprocess containers (BPCs) for use…

Simplifying AAV Downstream Process and Product Characterization: A Look at Purification and Analytical Tools

by BPI Contributor

This webcast features: Dr. Julia Baek, PhD, Staff Specialist, Ilaria Scarfone, PhD, MBA, Field Applications Specialist, and Chantelle Gaskin, Field Applications Specialist, Thermo Fisher The optimization of the downstream process for adeno-associated virus (AAV) production with consistent quality depends on the ability to characterize critical quality attributes affecting potency, purity, and safety of the final product. As the gene therapy field continues to push products through the clinical pipeline, an increasing need for efficient analytical tools has become evident. In…

How to Optimize Final Filling in Bioprocessing

by BPI Contributor

This webcast features: Andeka Ocio Velasco, Manufacturing & Process Validation Technician, Progenika Biopharma, a Grifols company; and Robert Martindale, Product Sales Manager, Masterflex EMEA, Antylia Scientific The final filling mistakes within bioprocessing are far too expensive to be allowed or tolerated. Continuous optimization is a commitment that all companies need to embrace to increase business profitability potential. Evaluating and utilizing new technologies will enable a faster methodology of process, increase the scaling up of bioprocesses, and increase the accuracy of…

Improving the Bioavailability of Challenging APIs using Hot Melt Extrusion with Polyvinyl Alcohol

by BPI Contributor

New molecular entities (NMEs) are becoming larger, more crystalline and more lipophilic and, as a result, less soluble. While approximately 40% of active pharmaceutical ingredients (APIs) currently on the market show poor solubility, it is estimated that between 60 and 90% of compounds in development have solubility challenges.1,2 For an oral formulation, API solubility and permeability are critical factors for absorption in the gastrointestinal tract. As a result of this, solubility-enhancing formulation techniques have become an area of focus for…

Evaluating Current Manufacturing Platforms for Viral Vector Production to Enable Gene Therapy Products

by BPI Contributor

The rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral vector manufacturing platforms to deliver these therapies. Adeno-associated virus (AAV) has become the vector of choice as it stands out for its safety profile since infection with the vector is not pathogenic. Also, AAV cannot replicate on its own and is not directly integrated into the host genome. Realizing the full potential of viral vector-based therapies requires a successful manufacturing platform for…

What Technologies Should You Apply to Your Vaccine-Specific Process?

by BPI Contributor

Vaccines have been protecting against disease since the late 1700s. They function by triggering the immune system to generate short-term and long-term responses. Because there are many pathogens, there are also many vaccines. They can be classified by antigen character, but the manufacturing flows used to produce them are relatively similar. Read now our Vaccine Bioprocessing Handbook to learn more on similarities and differences on Vaccine processes for: viral vaccines, Virus-Like Particle (VLP) Vaccines, Polysaccharide Conjugated Vaccines, Viral Vector Vaccines…

Ask the Expert: Selecting the Right Buffer Management Strategy

by BPI Contributor

Although buffers are among the simplest materials used in bioprocessing, they are critical to biopharmaceutical manufacturing success. Buffer preparation, storage, and handling can require significant investments in time, labor, equipment, and facility space. Jenny Dunker, MSc, and Alexander Troken, PhD (global product managers for customized bioprocess solutions and for process liquids and buffers, respectively, at Cytiva), delivered an “Ask the Expert” presentation on 30 March 2021 to explore strategies for intensifying buffer management. Available Options Biopharmaceutical manufacturers often prepare buffers…