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Validation 4.0: An industry transformation

by Bryan Ennis, CEO and co-founder of Sware, Inc.

The life sciences industry is on the precipice of a new frontier — a future that is digital-first and technology-led. With the mass acceleration and adoption of software-as-a-service (SaaS) cloud systems—from discovery through to point of care—widespread digital transformation is a key business driver, saving companies critical time, resources, and spending. Despite this ongoing industry-wide shift, one business-critical aspect common to regulated companies lags: validation. Historically, compliance has followed the industry practice of Computer System Validation (CSV), which is paper-driven,…

AAVs: The future of gene therapies, but what will it take to make them stable?

by Halo Labs

Characterize adeno-associated viruses (AAVs) for aggregation, stability, and particles at low volume for accelerated development of life-saving gene therapies. Development can further be accelerated by monitoring critical quality attribute parameters like subvisible particles (SVP) concentration early in the development process. Capsid degradation and nucleic acid leakage can both occur under different formulation and storage conditions and contribute to the accumulation of aggregates. Characterizing candidates earlier in the development process is best as it identifies and eliminates inherently unstable candidates before…

Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality

by BPI Contributor

The rate of innovation within Cell and Gene Therapy is incredible and will continue to grow at an exponential rate as new methodologies are developed. With the novel techniques, come new and improved manufacturing procedures for sought after therapies. The use of viral vectors is now a common approach within the sector, but there are still difficulties when scaling up for bioprocessing. An example being a recovery range of 5-30%, a less than optimal result within the manufacturing process. When…

Designing a Plasmid DNA Downstream Purification Process

by BPI Contributor

mRNA plasmid-based DNA vaccines, and advanced modalities using viral vectors, are at the forefront of the fight against cancer, cardiovascular, immunological, and infectious diseases. To reach their full potential and benefit as many patients as possible, however, workflows used for their manufacture must achieve greater efficiency. A critical step in the process is production of plasmid DNA (pDNA), which traditionally, delivers low yields and requires complex purification schemes. This new process development book provides you with guidance for your plasmid…

Innovations in Single-Use Technology Help Advance Downstream Processing

by BPI Contributor

Biopharmaceutical manufacturers across the globe are trying to rapidly expand their production capacity to meet the growing demand for new therapies. A key challenge they face is to scale that expansion cost-effectively while protecting the quality and integrity of their production processes. One way they are achieving this growth is through expanded use of single-use systems (SUS). This informative new Avantor® Technical Article details several ways SUS technology can help improve throughput and productivity in key downstream processes that routinely…

Best Practices for Oncolytic Virus Design, Development, and Manufacturing

by BPI Contributor

Oncolytic viruses (OVs) have the potential to become a very important pillar in the treatment of cancer because of their dual mechanism killing infected cancer cells and triggering anticancer immune response to also destroy uninfected cancer cells. This motivates researchers continually optimize oncolytic viral vectors to further improve their safety, efficacy as well as manufacturability for a commercial scale-up. As biopharmaceutical manufactures just begin to explore the prospect of OVs based therapies, the need for contract development and manufacturing organizations…

Downstream Process Development for the Purification of Biosimilar Insulin from Escherichia Coli

by BPI Contributor

This webcast features: Sharon Bola, Global Product Manager, Process Chromatography, Bio-Rad Laboratories. With the increasing global demand for insulin product, there is a need to develop a more efficient and economical process for the production of recombinant insulin therapeutics. In this webcast, we will present an efficient downstream processing workflow for recombinant human insulin production using Escherichia Coli as the host system. Data will be presented for sample preparation and purification results of proinsulin and insulin. Size exclusion was identified…

Building and demonstrating quality of mAb therapies from the ground up

by USP

The demand for monoclonal antibody (mAb) therapies is growing at an unprecedented rate likely due to their proven effectiveness in treating a wide range of illnesses. The recent pandemic is just one example of a situation where the potential of mAbs to reverse even the most severe disease was realized. This bodes well for mAb biosimilar manufacturers ready to bring many more products to market over the next decade. Public impact MAbs had a significant head start over novel technologies…

Robust and Scalable MAb Capture Facilitated by a Novel Convecdiff Membrane Structure

by BPI Contributor

Alternative stationary phases are being developed to solve the shortcomings of bead chromatography processes, namely high diffusional resistance leading to long processing cycles (4–6 h). Targeted lifetimes of 75–150 bind and elute cycles, taking sometimes years to achieve and requiring cleaning and respective validation, storage, and column unpacking and repacking, elevate costs and introduce increasingly unacceptable bioburden risks. Chromatographic membranes, due to intrinsically high mass transfer rates, overcome these limitations, enabling residence times of seconds and full lifetime utilization (75–150…

Comprehensive Solutions for Your Vaccine Platforms

by BPI Contributor

You want to scale and deliver your vaccine to the world quickly. Our collaborative global vaccine capabilities will take your innovation from pre-clinical to full-scale GMP-manufacturing efficiently, safely, and cost-effectively. Our new handbook describes how our global capabilities can help you achieve these goals for all your modalities/platforms including inactivated/live attenuated vaccines, subunit vaccines, VLP vaccines, viral vector vaccines, pDNA vaccines, mRNA vaccines.