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Application Note: Early-Stage Process Optimization for Seamless Scaling of MSC Therapies

A single dose of MSC therapy could consist of billions of cells per patient. To sustainably meet this clinical demand, cell expansion processes must be transformed from static cultures to suspension-based systems. This application note describes an efficient approach to process optimization in a scale-down model for suspension-based cell expansion. Read more to learn how to: • Comprehensively screen media and components for optimal cell growth • Rapidly characterize phenotypic and functional CQAs of MSCs • Develop process knowledge early…

CAR-T approvals marred by autologous manufacturing limitations, says Allogene

Autologous therapies have not kept up with demand says Allogene Therapeutics, which claims only off-the-shelf cell therapies can serve larger patient populations. While the approval of Novartis’ Kymriah (tisagenlecleucel) in 2017 marked a breakthrough for chimeric antigen receptor (CAR) T-cell therapies, the sector has been slow to blossom. However, the past year or so has seen some breakthroughs in the space: Approvals for Bristol-Myers Squibb’s Breyanzi (liso-cel) and Abecma (ide-cel), and J&J’s Carvykti (ciltacel). Meanwhile, last month Gilead’s Yescarta (axicabtagene…

Analytical Tools to Improve Production of Full Capsids in Initial Stages of AAV Process Development

This webcast features: Ivana Petrović Koshmak, PhD, Head of Upstream Process Development, BIA Separations, now a Sartorius company. Empty AAV capsids are known contributors of immunogenicity in gene therapy products. Reducing them below 10% during downstream process is difficult if they constitute the vast majority of total AAV produced in harvest – the solution is a further optimization of harvest. Determining the factors that improve production of full AAVs is possible at the initial stages of upstream process development, with…

ALSA latest VC firm to contract Lonza to service its portfolio

Lonza says small to mid-sized companies represent the bulk of its customers as it adds ALSA Ventures’ biopharma portfolio to its client list. European biotech investment firm ALSA has contracted Lonza to help develop and manufacture molecules within its biologics and small molecule company portfolio. The deal, financials of which have not been divulged, will see ALSA’s portfolio companies – which include Promatix, Montis Biosciences, Epsilogen, and Oxford BioTherapeutics – leverage Lonza’s development and manufacturing services and network, along with…

Bora Pharmaceuticals bolsters CDMO biz with Eden buy

As part of its five-year plan, Bora Pharmaceuticals will initially invest $50 million to acquire the CDMO assets of Eden Biologics in Taiwan. Taiwan-based contract development manufacturing organization (CDMO) Bora Pharmaceuticals has said it will initially invest $50 million and up to $100 million to acquire Eden’s CDMO assets. Through the acquisition, Bora will gain assets located in Hsinchu Biomedical Science Park, Taiwan. According to the CDMO, this will build and expand its presence in the biological macromolecule and cell…

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

The development of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional…

Poloxamer: A Simple and Powerful Solution for Accelerating Dissolution

While oral administration remains the most popular route for drug delivery, many of the active pharmaceutical ingredients (APIs) in use and development today exhibit low bioavailability, owing to low solubility which leads to a lower passage through the intestinal membrane, a key step to enter the systemic circulation. As such, formulators have developed a toolkit of enabling formulation techniques to increase bioavailability, including solid-state modification, formulation with lipids, salt formation with meglumine and complexation with cyclodextrins. However, the high degree…

Emergent ditched 400m vaccines amid quality and staff issues, report finds

Emergent BioSolutions hid evidence of contamination and destroyed nearly 400 million doses of J&J and AstraZeneca vaccines, a US Government staff report has found. Emergent was one of the benefactors from the US Government’s efforts in countering COVID-19, winning a Trump Administration contract worth $628 million to make the Johnson & Johnson (J&J) and AstraZeneca vaccines. However, the contract development and manufacturing organization (CDMO) was hit with an FDA Form 483 and a directive to stop production at its Bayview,…

Streamline cGMP Viral Vector Analytical Challenges With Robust and Sensitive Impurity, Fragment Sizing, and Oncogene Quantitation Assays

This webcast features: Jonas Buege, Product Manager, Thermo Fisher Scientific. The therapeutic potential of viral vector-based gene therapies is tremendous, but with some recently adverse outcomes in clinical trials, the safety of these drugs has come into question. Both regulatory agencies and manufacturers are working hard to define appropriate critical quality attributes and identify process-related impurities crucial to ensuring patient safety. These requirements increase the demand of analytical development teams working on viral vectors, over traditional biopharmaceuticals, to utilize novel…

JSR launches services firm for biosimilar development

Newly formed business division Similis Bio will help companies improve efficiency and cost of biosimilar development, says JSR Life Sciences. According to JSR, Similis will provide biosimilar drug developers with solutions to drive development timelines and decrease associated costs. Additionally, Similis will supply partners with data to establish a biosimilar target as well as offering complete analytical and process development packages. The data packages include analytical procedures, product data, process knowledge, and CMC templates from a centralized model created to…