Newsletter | April 14, 2025

04.14.25 -- Embracing Turnkey And Outsourced Quality Management In Biopharma

SPONSOR

Navigating Next-Generation Quality Control Strategies For AAV Testing

Explore essential quality control strategies for AAV-based gene therapies, including advanced testing methods and regulatory insights, to ensure safety and efficacy in delivering transformative treatments. Click to learn more!

FOCUS ON OUTSOURCING

Embracing Turnkey And Outsourced Quality Management In Biopharma

In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.

Strategies For Engineering Mammalian Cells To Express Difficult Proteins

By leveraging cells equipped with an existing TARGATT™ landing pad, we demonstrate how inducible expression can be efficiently achieved within just 4-6 weeks after donor plasmid creation.

Advancing Treatments For Pediatric Patients With Rare Diseases

Advancing cell and gene therapies for rare pediatric diseases requires overcoming unique challenges in trial design, patient access, and long-term follow-up.

Analytical Comparability Of Five Alternative AAV9 Downstream Processes

Explore how two-column AAV processes can enhance yield and potency while maintaining high-quality standards in the production of gene therapy products.

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.

Insights On How To Boost CMC Regulatory Efficiency In Gene Therapy

Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

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.

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.

Meet An Optimized Suspension-Based Platform Technology

Discover a ready-to-use, suspension-based platform technology for transient transfection of LVVs that eliminates the need to transition from small-scale adherent processes.

Future Proofing The Cell And Gene Therapy Supply Chain

Uncover guiding principles to ensure that your CGT supply chain is future-proof and learn how an agile, flexible approach can help advance your project with reduced costs and delays.

SPONSOR

Webinar: Harnessing the Potential of Gene Therapies: Innovations and improvements in Viral Gene Therapy

Explore innovations in viral gene therapy with experts Dr. Steven Gray and Eric Talley. Dr. Gray will discuss AAV-mediated therapies for neurological diseases and strategies to streamline studies and reduce costs. Eric Talley will highlight manufacturing improvements addressing key challenges. Learn about regulatory pathways, technological advancements, and solutions driving the development of life-changing gene therapies. Click here to learn more.

OUTSOURCING SOLUTIONS

Viral Clearance Studies To Meet Your Timelines - MilliporeSigma

End-to-End CDMO Solutions For CGT Success - GC Cell

UpTempoâ„  AAV Platform Process - Catalent

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