A Future Gene Therapy Could Be Delivered in Tiny ‘Nanocontainers’

| January 28, 2020

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A Swiss research group has developed tiny plastic particles that could carry gene therapies to the center of the cell with less risk of getting attacked by the immune system than conventional gene therapies. The majority of gene therapies in use today are delivered to the DNA of target cells using viral vectors. While efficient at their job, viral vectors can risk triggering the immune system to destroy them. This can lead to the therapy becoming ineffective.

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Ruminating on Bioprocessing 4.0

Article | February 18, 2020

The Bioprocessing 4.0 concept seeks to apply automation and technology to the digital transformation of biologics manufacturing. As the paradigm moves forward, it faces barriers to its adoption, according to Eric Langer, president of BioPlan Associates. “Perhaps the greatest challenges involve unsecured links and adapting the applications to areas where automation is critically needed today,” says Langer. “Unresolved security issues could seriously affect a company’s data in a regulated environment, so they will need to have iron-clad anti-hacking protection in place. Unfortunately, cyber security is not yet a top focus for the industry.”

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Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | February 18, 2020

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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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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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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