OUTSOURCING ARTICLES
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![GettyImages-532447321-children-kids-workout-exercise]( "From \"Up & Coming\" To \"Fully Formed\": Maturing Our mRNA Outsourcing Partnerships")
From "Up & Coming" To "Fully Formed": Maturing Our mRNA Outsourcing PartnershipsIn the first- of this three-part article series, several mRNA execs share their perspectives on the world of partnering in the RNA therapeutics space, assessing first the current state of CDMO partnerships and how they anticipate this critical supportive infrastructure will grow in the years ahead.
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![GettyImages-2036497686-lab-team-collaboration-laboratory-tablet-computer]( "Have We Got Novel Drug Production And Compliance Timelines All Wrong?")
Have We Got Novel Drug Production And Compliance Timelines All Wrong?Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.
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![FDA-GettyImages-679546546]( "Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products")
Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy ProductsFDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.
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![Connecting the dots-GettyImages-1311926130]( "2 “Must-Haves” In mRNA CDMO Outsourcing Partnerships")
2 “Must-Haves” In mRNA CDMO Outsourcing PartnershipsIn the final installment of this two-part series, Jain shares his assessment of the partnering landscape for mRNA therapeutic candidates. Though capacity has been a hot-button topic/need for other modalities in the ATMP space, his tips for evaluating CDMOs for mRNA therapeutics keep us aligned around the importance of capability and flexibility in outsourcing partnerships, especially when working with a nascent therapeutic modality.
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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.
OUTSOURCING VIDEOS
To unlock the potential of your mRNA therapies and accelerate your development and manufacturing program, discover the benefits of a novel PCR-based mRNA drug substance manufacturing process.
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.
Hear from inSeption Group clients as they share their experiences working with us. Watch as they recount their journeys, highlighting the exceptional service and support they received.
Tune in as Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx share supply chain and manufacturing capacity constraints in the face of the urgency to address COVID-19. This is an excerpt from the Bioprocess Online Live event - mRNA Manufacturing: Bright Future, Big Challenges.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1288438537 ecosystem]( "Clinical Research As A Delicate Ecosystem")
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
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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-1483104506 Document Digitization Concept]( "A Sustainable, Efficient Approach To Enhance Equipment Qualification")
Explore compelling reasons to digitize your qualification documents and the benefits of a sustainable and efficient approach that utilizes digital tools to enhance your equipment qualification process.
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![GettyImages-1327112218 Scientist using a laptop in a laboratory]( "Tackling Antimicrobial Resistance")
Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.
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![Gene Therapy GettyImages-1164556175]( "Advancing Cell And Gene Therapy Clinical Development In 2023")
Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.
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![GettyImages-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
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![Outsourcing RNA Feature Image]( "How Outsourcing RNA-LNP Production Can Have A Competitive Advantage")
Manufacturing RNA-containing LNPs demands specialized expertise Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
