OUTSOURCING ARTICLES
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![Education-GettyImages-498337698]( "“A Particular Set Of Skills:” Outsourcing Considerations For mRNA Therapeutics")
“A Particular Set Of Skills:” Outsourcing Considerations For mRNA TherapeuticsIn the first of this two-part article series, Jain offers us his observations on the growth of the mRNA outsourcing sector, as well as the most important learnings he’s gleaned from engaging and contracting CDMOs in this space — particularly in these “earlier” days of the RNA therapeutics industry.
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![bioreactor for cell culture-GettyImages-517743648]( "A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers")
A Deeper Look At What's Driving Dependence On Biotech Contract ManufacturersAre you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.
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![Leprechaun Man Dancing-GettyImages-538148163]( "ARW’s ATMP Manufacturing Must-Reads (ST. PATRICK’S DAY EDITION!)")
ARW’s ATMP Manufacturing Must-Reads (ST. PATRICK’S DAY EDITION!)Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.
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![GettyImages-1397698830 Female scientist working on antiviral drug in laboratory]( "Comparability Considerations For mRNA Product Development")
Comparability Considerations For mRNA Product DevelopmentGiven the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.
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![Industrial technology-GettyImages-1184804468]( "How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing")
How Pharma 4.0 Can Unlock The Full Potential Of External ManufacturingTo address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
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![2024-GettyImages-1699060818]( "Cell & Gene Therapies: How Can Our Knowledge Of 2023 Inform Our Predictions For 2024?")
Cell & Gene Therapies: How Can Our Knowledge Of 2023 Inform Our Predictions For 2024?2024 promises a potential turnaround and blue skies for cell and gene therapies. Let’s explore each modality’s prospects: oligos and mRNA, cell therapies, and viral gene therapies.
OUTSOURCING VIDEOS
mRNA-based therapeutics require comprehensive analytical testing to meet regulatory requirements. Optimize processes and ensure fast and reliable results as you bring your product to market.
Examine the challenges CGT innovators face and how adhering to GMP requirements from an early stage helps to ensure successful downstream applications from early clinical development to commercial phase.
Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support that Cytiva offers to facilitate your documentation progress.
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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![GettyImages-1313742092 tech partner]( "The Execution Stage Of Technology Transfer")
What are the key elements in the readiness stage of a technology transfer is critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.
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![Regulatory network digital EHR EMR patient data GettyImages-1298626492]( "Getting CMC Right For Emerging Technologies")
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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![Developing mRNA Vaccines GettyImages-1307593959]( "Consolidating The Supply Chain For mRNA")
Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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![GettyImages-1387090964 cell and gene therapy]( "Gene And Cell Therapy: Planning For Manufacturing Success Early")
As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Supercharge Your Supply Chain: Harness AI To Gain Competitive Advantage")
The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.
