Alison Moore

Demonstrating the technical leadership of SK pharmteco! 🧬 Catch up with our team at ASGCT to discuss how SKPT can support your #cellandgene development!

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Among #cell and #genetherapy companies, the pressure for manufacturing innovation and optimization can incentivize them to seek third-party partners who possess technical, manufacturing, and regulatory expertise. In addition to industry giants that include Lonza, Catalent​, WuXi Advanced Therapies, Minaris Regenerative Medicine, and others, there are specialty CDMOs serving the CGT marketplace. For example, FUJIFILM Cellular Dynamics opened a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products. Helixmith, a biotech company with an extensive gene therapy pipeline and a CAR-T program targeting solid tumors, expanded into CDMO services for early-stage CAR-T developers. ThermoGenesis launched CDMO services with expertise in CAR-T cells, T cell receptor (TCR), tumor-infiltrating leukocytes (TILs), natural killer cells (NKs), iPSCs, and MSCs. Anemocyte announced itself as the first BMO (Biotech Manufacturing Organization) in the field of cell and gene therapies. In addition to building 2000 sq. meters of GMP and GMP-compliant facilities for the production of ATMPs, its FLYn’ICE project is using drones equipped with cryogenic pods to achieve temperature controlled transit of cell and gene therapies. Excellos opened its doors with $15M in funding and access to one of the largest cellular material procurement portfolios yet to support cell and gene therapy manufacturing. RoslinCT, a cell and gene therapy CDMO based in the UK, and Lykan Bioscience, a CDMO focused on cellular therapeutics in Hopkinton, MA, merged to form an international CDMO specializing in advanced therapeutics—with a specialty in gene editing and iPSC capabilities. Of course, there have been hefty M&A deals inked within the cell and gene therapy CDMO sector as well. Thermo Fisher Scientific snagged Brammer Bio for an astonishing $1.7B, while Catalent acquired Paragon Bioservices for an impressive $1.2B and MaSTherCell for $315M. Also, HCATS, apceth, and Hitachi Chemical Co., Ltd. Regenerative Medicine now operate under Minaris Regenerative Medicine, while Charles River Laboratories (CRL) acquired Cognate BioServices for $875M. Ascend Gene & Cell Therapies raised an impressive $132.5M to launch itself as a CDMO specializing in AVV-based gene therapies. In late 2023, Bayer opened a $250M cell therapy manufacturing facility to advance regenerative medicines on a global scale. Around the same time, Ajinomoto Co. acquired CDMO Forge Biologics for an astounding $620M to enhance its Bio-Pharma Services business. In January 2024, EXO Biologics launched its subsidiary, ExoXpertTM, as a CDMO specializing in exosomes. Similarly, Esco Aster is a global CDMO that is supporting the rapidly emerging field of EVs. Finally, Novo Holdings announced it was acquiring the global CDMO Catalent for a staggering $16.5 billion in enterprise value. Learn more here: https://lnkd.in/edtzMzx

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Are you experiencing Upstream Process Development screening capacity constraints? Leverage Culture Biosciences’ cloud-connected bioreactors to accelerate your project. #processdevelopment #processoptimization #cloudconnectivity #bioreactor #bioprocess

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📹In a video interview with Associate Editor Donald Tracy, MA, Melissa Lattanzi, VP, Emerging Therapies, Cencora discusses ways that #cellandgenetherapy developers can follow examples from the commercialization and distribution of #orphandrugs

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Mark Tornetta, VP of Biologics Discovery at Tavotek Biotherapeutics discussed "Fully synthetic nanobody libraries and how to manage the diversity they produce into late-stage pre-clinical" at #DDSS. This insightful presentation took place on #Day1 of #DDSS2024! Keep an eye out for further updates from #15thddss2024. #PharmaInnovation #UnlockPotential #summit2024 #staytunedformore."

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Come and watch our latest webinar to learn more about Mabion and why we are your CDMO of choice! #CDMO #Mabion

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Natural killer (NK) cells are lymphocytes of the innate immune system. A key feature of NK cells is their ability to recognize a wide range of cells in distress, particularly tumour cells and cells infected with viruses. They combine both direct effector functions against their cellular targets and participate in the generation, shaping and maintenance of a multicellular immune response. As our understanding has deepened, several therapeutic strategies focused on NK cells have been conceived and are currently in various stages of development, from preclinical investigations to clinical trials. Here they explore in detail the complexity of NK cell biology in humans and highlight the role of these cells in cancer immunity. Here they also analyse the harnessing of NK cell immunity through immune checkpoint inhibitors, NK cell engagers, and infusions of preactivated or genetically modified, autologous or allogeneic NK cell products.

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Thoughts on this? >> Takeda budgets $230M for plasma therapy facility expansion in California >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #biotech #pharma #pharmaceutical #healthcare

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Century Therapeutics Raises $60 Million, Acquires Clade Therapeutics, and Expands Pipeline of Allogeneic, iPSC-Derived Cellular Therapies - https://lnkd.in/ehDg3gC9 Century Therapeutics, Inc (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024. Century plans to pursue additional autoimmune disease indication regulatory filings in 2024. Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors. Concurrently, Century announced pipeline and platform enhancements through the acquisition of Clade Therapeutics, Inc. (“Clade”), a privately-held biotech company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases. “Today’s news signifies a transformative milestone for Century, as we accelerate and broaden our research and development initiatives in autoimmune diseases and iPSC-derived cell therapy on a larger scale. With support from a distinguished group of investors, coupled with the acquisition of Clade, we are poised for continued success,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century. “Under the leadership of a pioneering team of scientists and senior leaders with decades of experience in stem cell biology and iPSC differentiation enabled by significant capital investment from their investors, Clade has established a discovery engine with industry-changing potential,” said Hy Levitsky, M.D., President of R&D of Century. Read more at: https://lnkd.in/ehDg3gC9 #ipsc #cancer #autoimmunediseases

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The FDA has issued a draft guidance that can be a paradigm shift in the biosimilar landscape. By potentially removing the requirement for switching studies, which aim to demonstrate interchangeability between a biosimilar and its reference product, this guidance has the power to catalyze innovation and improve market dynamics. The impact of biosimilars on the healthcare system has been substantial, with FDA-approved biosimilars generating $23.6 billion in savings since 2015. The new guidance can further accelerate this impact by lowering development costs, facilitating market entry, and fostering a more competitive landscape. This regulatory evolution encourages innovation from the ground up by leveraging advanced analytical methods and potentially reducing the need for extensive clinical trials. By streamlining the biosimilar approval process and leveraging advanced technologies, the FDA is creating a regulatory environment in this case that encourages innovation, fosters competition, and improves patient access to life-changing therapies. This is the promise of what many of us call smart regulation – driving progress in the spirit of America's enduring culture of ingenuity and entrepreneurship. https://lnkd.in/exVbx3Ys

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In BioPharm International's latest issue, our VP of Cell Line Development (CLD), Simon Keen, shares innovative approaches that can optimize cell line development for next-generation biologics. From vector construction to rapid cloning strategies, he provides insights on how to build a flexible and efficient CLD platform that reduces the potential for bottlenecks in the development pathway.   "Efficient and flexible cell line development (CLD) platforms are critical to meeting the growing global demand for biologics." says Simon Keen.   Dive into the full article to explore these advancements in detail: https://lnkd.in/epHXRy3d #CDMO #CRO #Celllinedevelopment #DrugDevelopment 

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GMP-manufactured CRISPR/Cas9 technology as an advantageous tool to support cancer immunotherapy The latest advancements in GMP procedures are allowing an efficient improviement of personalized medicine. In particular immunotherapy is strongly taking advantage of clinical manufacturing platforms to cure patients who are refractory to previous therapy or who relapse upon a first period of remission. CRISPR/Cas9 technology has become the most widely used gene-editing tool in cancer immunotherapy favoring differentiation and persistence of genetically modified T-cells. The discovery of cancer-selected markers remains one of the principle obstacles while the use of allogenic CRISPR/Cas9-modified CAR T-cells is overcoming the difficulties to treat relapsing cancer cells showing an antigen different from that expressed at the onset of the disease. CAR T-cells generated against multiple tumor targets are preventing relapsing events. The manufacturing processes still comprised procedures performed manually even if supported by semi-automated manner, which result in product variability and very high cost. The development of a more controlled and cost-effective manufacturing process remains the pivotal aim to ensure CAR T-cells therapy for all patients. https://lnkd.in/eWkEGiNq

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We love BioPharma Dive's round up of FDA decisions to watch in #Q3. We're keeping an eye on Bristol Myers Squibb and Karuna Therapeutics' #schizophrenia drug, Lykos Therapeutics' #PTSD therapy, Gilead Sciences' liver drug for #primarybiliarycholangitis, Ascendis Pharma' #rare endocrine condition #hypoparathyroidism, and Adaptimmune's cell therapy drug for synovial sarcoma. Read more here: https://lnkd.in/gJDP8sCE

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One year ago, our Chief Scientific Officer, Li Peng, was named to Endpoints News’ list of top women leading biopharma R&D – a testament to her drive and dedication to develop glycan editing, an entirely new field of drug development. Li has played a major role in the Palleon story and how our science came to be, developing an enzyme-based approach to editing cell-surface sugars. In case you missed it, view the list of honorees here: https://bit.ly/3OmW1gj #glycotime

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Advancing cell and gene therapies (CGTs) globally presents unique hurdles at every step, and Labcorp has the experience and capabilities to help you overcome them. In a recent presentation for the Korea Biomedicine Industry Association (KoBIA), Maryland Rosenfeld Franklin, PhD, vice president and enterprise head of CGT at Labcorp, discussed some of these challenges and explored their solutions. Watch the recorded webinar to learn more. #CellandGeneTherapy #CellTherapy #GeneTherapy

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iRegene Receives IND approval from U.S. FDA to Start Clinical Trial for Parkinson’s Disease - https://lnkd.in/gbKS7Z8M On June 20 (UTC-4), the U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene Therapeutics targeting Parkinson’s Disease. This marks a significant milestone as NouvNeu001 becomes the world’s first chemically induced allogeneic cell therapy product to enter clinical stages for Parkinson’s disease in the US. Previously, the “Combined Phase I/II Clinical Study” of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. On June 20, 2024, iRegene further announced IND approval of NouvNeu001 by the U.S. FDA for the treatment of mid-to-late stage of Parkinson’s disease. Read more at: https://lnkd.in/gbKS7Z8M #parkinsonsdisease #regenerativemedicine #stemcell

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Astellas Inks Second CAR-T Agreement with Poseida to Develop ‘Convertible’ Cancer Therapies Astellas Pharma on Wednesday entered into a collaboration and license agreement with Poseida Therapeutics to develop novel CAR-T therapies for solid tumors. Under the deal, Astellas will pay an upfront fee of $50 million and has pledged up to $550 million in potential development, sales and other contingent payments. Poseida will also be eligible for up to low-double digit tiered royalties on net sales. Astellas will conduct the transaction through its subsidiary Xyphos Biosciences. The collaboration is designed to combine “the innovative cell therapy platforms from each of the companies,” according to Wednesday’s announcement. Poseida will contribute its proprietary allogeneic CAR-T platform, while Xyphos will lend both its ACCEL and convertibleCAR technologies. The partnership’s goal is to produce one CAR-T construct, which in turn will yield two convertibleCAR product candidates for solid tumors. https://lnkd.in/gGZG4KKY

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Process validation for cell and gene therapy products is a daunting challenge when scaling up manufacturing. In this snippet from a recent webinar, AGC Biologics' Senior Manager of MSAT reviews the primary considerations for process validation strategy in cell and gene therapy development. Wondering how to overcome these challenges and advance novel therapies from concept to market? View the full webinar to receive expert insights on navigating the journey to FDA/EMA approval: https://hubs.li/Q02Ghx4r0 #CellAndGeneTherapy #GeneTherapy #Biologics #Biopharmaceuticals #FDAApprovalProcess

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