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| Explore how shifting demand for oligos and peptides is driving outsourcing relationships and innovation in CDMO partnerships. Join our next Outsourced Pharma Live as we cover best practices for outsourcing these specialized therapeutics, focusing on capacity, regulatory challenges, and technology transfer. Register today to learn about the unique challenges and opportunities in scaling production for these complex molecules. |
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By Louis Garguilo, chief editor, Outsourced Pharma | Are we on the same page? Do we need to be? That is, how do we differ on what might seem like the mundane defining of CDMOs as small, medium, or large? Some readers have been asking. How might this determination be relative and important to individual sponsors? Our Advisory Board members weigh in. | |
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UK MHRA Draft Guidance On Individualized mRNA Cancer Immunotherapies | By Tiffany Lucas, Ph.D. and Ifty Saiyed, Eliquent Life Sciences | The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31. |
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Upstream Optimization Paved A Straightforward Path For Full Capsids In AAV6 | Poster | By James Fasano, Azam Hassaninasab, Daniel Kennedy, Theresa Dao, et al., ElevateBio | Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product. |
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Integrating Analytical Method Development And Quality Control | Article | By Michael Sousa, Eli Kraus, and Manish Tandon, Landmark Bio | With the advancement of cell and gene therapies, a well-integrated analytical framework will be critical for accelerating development timelines and optimizing regulatory submissions. |
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A Focus On Cell Therapy: CAR-T, CAR-NK, And Beyond | Article | By Tae Whan Kim, GC Cell | As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology. |
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Overcoming Challenges In AAV And LV Viral Vector Manufacturing | White Paper | By Mathias Kahl, Stephan Bauer, Dr. Daniel Köhler, Dr. Tobias Thom, et al., IDT Biologika | Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs for viral vector production. |
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Scalable Suspension LVV Production Platforms | Webinar | Lonza | Review a scalable suspension-based Lenti production platform using a proprietary HEK293T clonal cell line and improvement steps to generate commercially viable therapies from concept to patient. |
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Next-Generation CRISPR Approaches | White Paper | Aldevron | By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond. |
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Enabling The Outcome In EMEA | Cryoport Systems | With our global network of facilities and services, Cryoport Systems is a strategic partner of choice for temperature-controlled supply chain management of critical materials. |
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Two-Sided Pharmaceutical Labeler: HERMA 362C | HERMA | The HERMA 362C is a compact and flexible two-sided labeling machine designed for quick and easy changeovers. It operates largely without format parts, accommodating a wide range of product formats. |
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Stand-Alone Fill/Finish Service Offering | Viralgen | Review our technical capabilities and specifications and discover how a partner with fill-finish services designed to take advantage of 100% of the product can guide your product to commercial success. |
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OUTSOURCED PHARMA CAPACITY UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs. |
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