Newsletter | April 17, 2025

04.17.25 -- How AI Is A Game-Changer For Auditing Compliance And Efficiency

SPONSOR

The biotechnology sector is transforming with AI, automation, and digitalization playing key roles in drug development and manufacturing. As the industry moves toward end-to-end digitalization, don't miss the opportunity to join the 2025 ISPE Biotechnology Conference, 2 – 3 June in Boston, Massachusetts, USA, and virtually, to gain a holistic perspective on how to view and apply digital transformation in biopharmaceutical manufacturing. Register today

FOCUS ON OUTSOURCING

How AI Is A Game-Changer For Auditing Compliance And Efficiency

In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

Optimizing Cell Therapy Development

Plan early and align research, development, and commercial priorities to ensure a seamless transition from clinical development to scalable, cost-efficient commercialization.

Digging Into Manufacturing Priorities For Viral Vectors

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

Comparing Synthesis Processes To Establish rAAV Batch Quality

In this study, we present a comprehensive analysis of various published and newly developed dsDNA conversion processes that were tested using the same sequencing chemistry.

Opportunities To Accelerate Allogeneic Cell Therapy

Learn more about the potential of allogeneic cell therapies to combine the efficacy of personalized medicine with the scalability, accessibility, and uniformity of traditional off-the-shelf therapeutics.

Strengthening Europe's Advanced Therapy Supply Chain

Ensure the seamless development and commercialization of your ATMPs in Europe with integrated supply chain solutions that optimize logistics, biostorage, and regulatory compliance.

CGMP-Validated RCL Assay Used For Release Testing

Ensure the safety and efficacy of lentiviral-based therapies by addressing the risks of replication-competent lentiviruses (RCLs) through advanced monitoring and control strategies.

A Scalable Platform To Revolutionize Gene Therapy Manufacturing

Discover how our innovative rAAV production platform can revolutionize your gene therapy pipeline with unparalleled yield, quality, and scalability.

Collaborate With A Partner To Bring Your Rare Disease Therapy To Clinic

Choosing the CDMO best suited to manufacture your rare disease therapy can be challenging. Ideally, a CDMO will prioritize your goals while working to ensure quality and regulatory success.

Supporting Cell And Gene Therapy Manufacturing

Ensuring the safety and efficacy of cell and gene therapy treatments necessitates rigorous quality control. See how an outsourcing partner can help you deliver safe, efficacious therapies to patients.

OUTSOURCING SOLUTIONS

Alcami Capacity Update July 2024: Cell & Gene Therapy - Alcami

Expertise In Commercial Fill-Finish For More Than 30 Years - IDT Biologika

Accelerating CGT With Speed, Cost, And Innovation Advantages - VintaBio

Advancing CRISPR-Based Therapeutic Development - Aldevron

Manufacturing GTP And GMP - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

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