Newsletter | July 14, 2025

07.14.25 -- June 2025 — CDMO Opportunities And Threats Report

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Accelerate Your AAV Journey To IND And Beyond: Critical Insights On Some Tough QC Challenges

This webinar addresses QC topics that are crucial to consider when navigating regulatory complexities and optimizing development timelines, with specific regards to replication-competent AAV, viral clearance, and impurities impacting product quality. Watch it here.

FOCUS ON OUTSOURCING

June 2025 — 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.

EMA Support For Rare Disease Therapies

Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.

Choosing The Right PBMCS For Your Research And Product Development Needs

Enhance the success of your research and cell therapy programs by sourcing PBMCs with proven functional performance and donor-specific insights.

Part One: Challenges In LVV Purification And Quantitation

Discover how a company is overcoming purification challenges and advancing scalable, GMP-ready LVV manufacturing for gene and cell therapies.

Supporting The Clinical Journey From Discovery To Delivery

Clinical Trials Day celebrates the science and collaboration driving medical breakthroughs — discover how Cryoport Systems helps power this progress behind the scenes.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

How-To Master Tech Transfer: Strategies To Sidestep Common Pitfalls

Ensure a smooth and efficient technology transfer by following key strategies and avoiding common pitfalls to streamline your process and achieve consistent, error-free results.

Unlocking Potential: A Deep Dive Into AAV Development And Manufacturing

When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

Overcome Scale-Up Hurdles For Adenovirus-Based Vaccine Manufacturing

Learn about the development and effective scale-up of a robust process for manufacturing adenovirus vectors and the obstacles that were encountered and successfully overcome.

Cell Line Development For AAV

As advanced therapies race forward, staying ahead is paramount. Harnessing technology, sponsors can unlock efficiencies and propel AAV production to new heights.

Demonstrating Value Throughout The Product Development Lifecycle

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

OUTSOURCING SOLUTIONS

SK pharmteco Capacity Update April 2025: Cell & Gene Therapy - SK pharmteco

Alcami Capacity Update October 2024: Fill/Finish - Alcami

A Platform For Lentivirus-Based Cell And Gene Therapy Manufacturing - MilliporeSigma

UpTempo AAV Platform Process - Catalent

Allogeneic And Autologous Cell Therapy CDMO Services - FUJIFILM Biotechnologies

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