Jens H. Vogel, Ph.D.

Roche's recent decision to offload their Vacaville facility highlights the increasing importance of cell line productivity in biomanufacturing strategy. According to Dan Stanton of Bioprocess Insider, Roche is moving towards more high titer processes and products with lower volume demands. (You can read the article here https://lnkd.in/erRx597k) Agile manufacturing strategies are enabled by cell line productivity, which allows for the same amount of drug substance to be produced in smaller bioreactors. This, in turn, allows for smaller clean rooms and lower running costs. Just - Evotec Biologics' J.CHO High Expression System cell lines, grown in perfusion bioreactors, produce over 4 g/L of antibody each day, equivalent to around 30 g/L in fed-batch mode (https://lnkd.in/eexeJrQA). This level of productivity allows for commercial quantities of antibody to be manufactured in 1000L single-use bioreactors in our modular J.POD facilities. As a result, large-scale stainless-steel facilities are becoming redundant. The future of biomanufacturing lies in maximizing cell line productivity, and our J.CHO system is leading the way. #biomanufacturing #celllineproductivity #JCHO #JPod #agilemanufacturing 👨‍⚕️Philip Boehme

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It’s exciting to see Oregon policy makers eager to learn how the state can work to build and strengthen every level of the state’s biotech ecosystem. Our three big takeaways today were… 1) Venture creation often starts in academic labs after new intellectual property is filed. If the state worked to increase research funding to flagship institutions like Oregon State University, the University of Oregon, Portland State, and OHSU, we would likely see an increase in the number of patents filed in Oregon. Additionally, any funding used to reduce tuition costs or prevent further increasess would limit the burden of student-debt on Oregonians, making entrepreneurship less risky for young people who would otherwise be forced into a traditional career path. Either policy could increase the number of biotech (and general deeptech)companies in Oregon. 2) The Oregon Bioscience Incubator and OTRADI is a wonderful organization that provides an essential early-stage landing pad for startups in the form of low-cost laboratory space. However, there’s a lot of room for impactful growth for OBI as the steward of biotech in Oregon and the Pacific Northwest. We identified a list of aspirational peers for OBI like MassBio, The Engine, and other government and non-government organizations around the globe. These organizations provide a template for success and roadmap for growing the biotech industry in Oregon. In my opinion, the legislature should adopt policies to increase OBI funding for improved facilities, increased SBIR/STTR-matching, and enhanced programming for entrepreneurial education and investor relations. Implementing these changes will increase the chance of success for Oregon-grown startups. Moreover, when coupled with Portland’s low cost-of-living compared to hubs like SF & Boston, these changes could attract other startups to the region. 3) Finally, we discussed what incentives there are for successful companies grown in Oregon to stay in Oregon. We discussed the recent example of AbSci, a 100 employee biotech company, which started in Portland but later moved to Vancouver, Washington for rational financial decisions — due in-part to Washington-state incentives. In my opinion, the state should work to assess and understand disparities between Oregon and other states’ (especially WA & CA) policies that incentivize companies to leave. Matching those incentives so Oregon companies stay in Oregon would be a great first step. More optimistically, the growth of biotech could be used to increase the number of companies in Portland’s urban core. Biotech companies, even those that leverage the latest laboratory automation tools, generally require their scientists be in-office 5 days/week to work in the lab. Policies from the state, or even the City of Portland, that support office-to-lab conversions would certainly be a boon for the industry and the City of Portland. Note, I’m biased here as someone working to grow an R&D team in Portland.

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The latest Sector Snapshot from the Alliance for Regenerative Medicine highlights the rapidly evolving landscape of #cellandgenetherapies. Recent breakthroughs, like the #FDAapprovals for #sicklecell and #hemophilia treatments, emphasize a strong #productpipeline. Beyond the headlines, the latest insights underscore the long-term value of #advancedtherapies. The analysis shows that despite upfront costs, these treatments are proving to be highly cost-effective, offering sustainable solutions by replacing the current standard of care with more durable options. As the sector continues to grow, understanding the economic and clinical impacts of these transformative medicines is critical for driving innovation and ensuring sustainability.

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PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™ WARREN, N.J., May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency. The application has been granted Priority Review with a target regulatory action date of November 13, 2024. "We are excited to be one step closer to bringing an approved therapy to patients with AADC deficiency in the United States," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The data collected to date continue to support the transformative benefit of Upstaza, this highly innovative gene therapy directly infused into the brain." About Upstaza™ (eladocagene exuparvovec) Upstaza is a one-time gene replacement therapy indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L–amino acid decarboxylase (AADC) deficiency with a severe phenotype. It is a recombinant adeno-associated virus serotype 2 (AAV2) https://lnkd.in/e5EvQp7D

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I am excited to announce that one of Access Discovery Bio’s first clients is Cache DNA based out of San Carlos, CA. Cache has an exciting new technology that allows for the “Caching” of DNA and RNA, allowing them to be stored at ambient room temperature. Caching can be done on a small scale with various tubes or can be completely integrated into existing automated technologies that handle plates for working at scale. This is a profound development in my eyes after decades of both working in biorepositories and shipping frozen samples all over the world. I have personally witnessed sample evaporation and loss despite long term cold storage. I’ve seen the dramatic rise in costs not only to create and maintain freezer farms but also to safely ship frozen samples which can often dip into the thousands for a single shipment. I have personally been on call and had to travel into a lab at 2am to recover samples in a failed freezer or during a power outage. I have also worked in the lab having to use various techniques to properly freeze or thaw samples to work with them. For many reasons, I see this as a transformational technology. Who doesn’t like to save massive amounts of money? Everyone does of course and this comes with the added benefits of reducing carbon footprints and helping the environment. Michael Becich and his team at Cache are a great group of scientists who have created something truly beneficial to basic science. Cache is presently offering free demo kits to select customers while supplies last. Given my network is made up almost entirely of people using or storing samples for research, please help me in giving this great start up a signal boost and please reach out directly to me with interest in either demo kits or more information. #biobanking #DNA #RNA #technology #biospecimens https://lnkd.in/eK9q9JQk

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Nucleus Biologics Launches QuickStart Media™: A Suite of Optimized Media Formulations That Provide a Head Start on Your Therapy Optimization - https://lnkd.in/gYKezEBS Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media and buffers for the cell and gene therapy industry, announces the launch of a novel platform to expedite the formulation and manufacture of custom media. This platform, called QuickStart Media™, is a groundbreaking addition to its comprehensive line of cell culture products and solutions and further demonstrates Nucleus Biologics’ expertise and dedication to the delivery of custom cell culture media, buffers, reagents, and services simpler and faster. As the name implies, QuickStart Media was developed to provide scientists with a head start in the development of a high performing, custom media. The formulations that carry the QuickStart Media brand have all been developed for high performance for specific cell types or functions but allow full customization of components and final packaging enabling researchers to tailor their product to fit their exact process or critical quality attributes (CQAs). This offering stands alone in the cell culture market by providing researchers with both the convenience of off-the-shelf and the flexibility of custom media. This process offers transparency through licensing that can both enhance performance and supply chain consistency. “Nucleus Biologics is committed to empowering scientists with the tools they need to drive innovation and discovery,” said David Sheehan, President and CEO of Nucleus Biologics. “QuickStart Media represents the first platform of proven formulations that can be optimized and licensed to allow unprecedented transparency. This flexibility not only accelerates the research process, but also speeds the time for therapy developers to get into the clinic. As a critical component of a therapy, the industry needs to shift its thinking and allow scientists to know what is in their media and optimize their therapy. Ultimately, this is about faster cures.” #cellculture #celltherapy #genetherapy #custommedia David De Leonardis Brad Taylor

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