Newsletter | December 5, 2024

12.05.24 -- October 2024 — CDMO Opportunities And Threats Report

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When navigating the clinical trials process to bring a molecule to market, meeting the regulatory standards required for the approval of new mRNA-based drug products is critical. A crucial aspect is developing extensive chemistry, manufacturing, and controls (CMC) documentation, outlining the quality of drug substance and product. This article explores the regulatory requirements for mRNA drug substance and product, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance. Download now!

FOCUS ON OUTSOURCING

October 2024 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

A CDMO's Checklist For Prospective Clients: Part 3

In the last entry of our client checklist series, we delve into crucial aspects such as project management, decision-making, MSA negotiations, and building trust in CDMO-client partnerships.

Identifying The Right Analytical Strategy For AAV Production

AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.

Demystifying CGT Studies In Australia And The Broader APAC Region

Though conducting your clinical trial in Australia may initially seem daunting, the benefits are ample. Australia is home to qualified CRO partners that will guide your CGT to regulatory success.

Exploring The Cost Considerations Of Immune Cell Therapies

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

Adapting A rcAAV Assay For Commercial Manufacturing

Better understand the intricacies of AAV triple transfection and how advances in vector production and cell line optimization are enhancing gene therapy.

A Deep Dive Into Expression Approaches For Biotherapeutics

Whether you’re at the discovery stage or thinking about commercial production, gain useful insights on expression formats from transient transfection, through stable pools to stable clones.

Quality Management Systems: Implementation Strategies And Compliance

A robust pharmaceutical quality system is pivotal in achieving safe and efficient drug manufacturing. Learn more about its importance and the optimal methods for implementation. 

Lentiviral Vector Platform: Right The First Time

Leveraging the right LVV manufacturing platform can accelerate timelines, better manage costs, and transform product development and potential for clinical success so that therapies reach patients in need.

Delivering The Science, Partnership And Technical Solutions You Need

Uncover how our collaborative approach positions us as an extended workbench for our partners, enabling faster, more effective solutions for patients.

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Despite significant advances, challenges remain in optimizing AAV-based treatments for broader clinical application. Join Cell & Gene Live on December 10th for a discussion on the latest developments in AAV vector design, manufacturing processes, and clinical strategies as well as key issues such as immunogenicity and regulatory considerations that are shaping the future of AAV gene therapies. Registration is free thanks to the support of Roche CustomBiotech.

OUTSOURCING SOLUTIONS

Cell And Gene Therapy Analytical Services - AGC Biologics

Virotherapy Manufacturing - ReciBioPharm

Technologies That Smartly Scale iPSC To Benefit Human Health - Cellistic

Helping Cell Therapy Innovators Bring Treatments To Market - Kincell Bio

Capacity Update October 2024: Cell & Gene Therapy - Viralgen

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