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| Webinar: Engineering Precision in Genetic Medicines | Precision matters in genome editing, where permanent DNA changes demand both potency and pinpoint specificity. In this webinar, ElevateBio shares how its genome editing toolbox combines assay-driven engineering, directed evolution, rational design, and AI to build bespoke editors. Using adenine base editors as a case study, the session explores strategies to minimize off-target and bystander edits for safer clinical translation. Click here to learn more. |
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| Digging Into Manufacturing Priorities For Viral Vectors | Article | Novartis Contract Manufacturing | Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies. |
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| Enhancing AAV Production Performance And Economics | Application Note | Touchlight | Enzymatically produced dbDNA offers safer, faster, and more scalable AAV manufacturing by reducing costs, improving full capsid yields, and enabling high‑fidelity, bacteria‑free DNA production. |
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By Louis Garguilo, chief editor, Outsourced Pharma | After graduating with a biology degree from Howard University and entering the pharma industry, Stephanie Wimberly found herself the only woman — the only black woman — in a manufacturing facility in Maryland. A supervisor made it clear he didn’t want her on his team; she was reassigned to the night shift at her facility. “I had a family to support, and night shift, or abuse, was not what I signed up for,” she says. “But I didn’t have many options.” Here is how she persevered, and prospered. | |
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By Louis Garguilo, chief editor, Outsourced Pharma | Three reports – on the oligonucleotide CDMO market; mRNA synthesis and manufacturing; and the bioconjugation space - demonstrate where our outsourcing industry is headed, and the important role of CDMOs to get us there. Ostensibly quite different market slices, these reports present us with the industrialization of our most advanced modalities. | |
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By BioPhorum | BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance. | |
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INDUSTRY INSIGHTS CONTINUED |
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| Balancing Early-Stage Needs With Future Success | Article | By Omar Baez, Comprehensive Cell Solutions | Streamlining the tech transfer process is a key variable in shortening development timelines and controlling costs, maximizing a molecule's potential for late-stage success. |
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| Capital Constraints In CDMO & Pharma M&A | Q&A | Vector BioMed | Capital constraints are reshaping CDMO and pharma strategies, driving selective M&A, prioritizing partnerships, and enforcing financial discipline amid tighter investment conditions. |
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| From Outsourced To In-House: Establishing On-Site Lab Services | Article | By Carolyn Garrett, Eurofins PSS Insourcing Solutions | Laboratory testing services for biopharmaceutical development often are outsourced, but insourcing offers sponsors greater control and stability by combining provider expertise with sponsor infrastructure. |
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| Join Outsourced Pharmaceutical Live’s Jeff Buguliskis and panelists on April 22nd at 11 AM Eastern for One Program, Many CDMOs: Managing Multi-Partner Strategies. Registration for this virtual event is free thanks to sponsor Thermo Fisher. |
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Our Advanced Therapies Overview | | Global cell and gene therapy CDMO providing GMP manufacturing, testing, and development services with commercial success, regulatory expertise, and advanced multi‑modality capabilities. |
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A Concept-To-Commercial Gene Therapy CDMO | | This adherent platform has been used to manufacture more than 450 Phase 1 and 2 clinical batches, spanning over 17 years and covering a variety of serotypes and indications. |
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