Accurate and reliable analytics are crucial in the development and manufacturing of viral-based drugs.

| September 27, 2019

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MiniTEM is an innovative analytics solution that uses artificial intelligence to automate the analysis of viral particle samples.

Spotlight

AxoGen, Inc.

It's time to rethink nerve repair! AxoGen (NASDAQ: AXGN) is a medical products company with a portfolio of proprietary products and technologies for peripheral nerve reconstruction and regeneration. People suffer traumatic injuries or undergo surgeries that impact the function of their peripheral nerves daily. Damage may cause loss of function and feeling. AxoGen is bringing the science of nerve repair to life with its Avance® Nerve Graft which AxoGen believes is the first and only commercially available allograft for bridging nerve discontinuities, AxoGuard® Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and AxoGuard® Nerve Protector that protects nerves during the healing process.

OTHER ARTICLES

Making Predictions by Digitizing Bioprocessing

Article | April 20, 2021

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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Pfizer, BioNTech Plan Clinical Trial for COVID-19 mRNA Vaccine Candidate

Article | April 9, 2020

Pfizer and BioNTech plan to begin human clinical trials on their lead COVID-19 therapeutic candidate, an mRNA vaccine, by the end of this month, the companies said today, through a collaboration that could generate up to $748 million for the German biotech. The companies announced plans last month to partner on BNT162, the first treatment to emerge from BioNTech’s accelerated COVID-19-focused development program, “Project Lightspeed.” BioNTech and Pfizer established collaboration intended to draw upon BioNTech’s proprietary mRNA vaccine platforms, and Pfizer’s expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.

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Better Purification and Recovery in Bioprocessing

Article | August 2, 2021

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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Wisconsin biotech companies could play key roles in long-term economic recovery from COVID-19 pandemic

Article | April 19, 2020

Whether it’s called a modern “Manhattan Project” or a medical moon shot, the concept of long-term economic recovery rests on how confident people are they won’t risk serious illness by venturing forth in public again. Wisconsin stands to be a significant part of such an undertaking, whatever it’s called. The shorter-term debate is well under way over the gradual lifting of COVID-19 emergency rules, such as the now-extended “safer-at-home” order in Wisconsin. At least a dozen states, including regional coalitions on the East and West coasts, are exploring next steps as they seek to balance responses to the virus with calls for reopening the economy, at least, in part. Wisconsin’s ability to shape longer-term responses will come from private and public resources, which range from companies engaged in production of diagnostics.

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Spotlight

AxoGen, Inc.

It's time to rethink nerve repair! AxoGen (NASDAQ: AXGN) is a medical products company with a portfolio of proprietary products and technologies for peripheral nerve reconstruction and regeneration. People suffer traumatic injuries or undergo surgeries that impact the function of their peripheral nerves daily. Damage may cause loss of function and feeling. AxoGen is bringing the science of nerve repair to life with its Avance® Nerve Graft which AxoGen believes is the first and only commercially available allograft for bridging nerve discontinuities, AxoGuard® Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and AxoGuard® Nerve Protector that protects nerves during the healing process.

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