Newsletter | December 9, 2024

12.09.24 -- Maintaining Harmony With Your CDMO Using 'The Middle Way'

SPONSOR

The field of gene therapy manufacturing faces a significant hurdle in the form of a lack of process standardization. There are ways to address this challenge, such as using standardized methods, materials, analytics, and documentation. By implementing these measures, it is possible to minimize supply chain bottlenecks and increase manufacturing efficiencies and scalability. Catalent explores how a complete platform approach to fast-track AAVs can enhance quality and efficiency. Click to learn more.

FOCUS ON OUTSOURCING

Maintaining Harmony With Your CDMO Using 'The Middle Way'

Sponsor and CDMO relationships are fertile ground for conflict. A measured approach can mitigate disruptions with troublesome contractors and high performers alike.

Development Of A Downstream Processing Platform For AAV

There is a growing need for innovative solutions that reduce costs while maintaining high product quality. This poster presents investigations to derive an economic and scalable method for purification of AAV.

NK Cells: 3 Strategies For Creating A Cost-Effective Program

Opportunities are arising for NK cell-based therapies to make a significant impact on patient care. Discover three strategies for creating a cost-effective NK cell biopharma product.

Smoothing The Path To Successful mRNA Manufacturing

Producing mRNA therapeutics requires navigating complex manufacturing challenges. A strategic partnership with an integrated CMO streamlines manufacturing processes and reduces costs.

A Proven AAV Platform To Drive Down Program Costs And Maximize Speed

To ensure that your adeno-associated virus (AAV) therapy reaches patients as soon as possible, begin your relationship with an experienced AAV manufacturer early in the development journey.

CRISPR RNPs And The Future Of Cell And Gene Therapy

Explore the potential of ribonucleoprotein (RNP) to deliver CRISPR materials more accurately, efficiently, and effectively, as well as the manufacturing challenges which require further attention.

DoE Reveals Key Parameters For Optimizing rAAV Productivity, Packaging

This Design of Experiment model was developed to address the multifactorial nature of large-scale transfection, where variables like viable cell density (VCD) and DNA amount jointly influence efficiency.

Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics

Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.

Exploring An Integrated Solution For AAV Vector Clinical Production

Every choice is critical in AAV vector production. Experts share how to make the right choices, from the process and cell line, to off-the-shelf plasmids and qualified analytical methods.

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.

SPONSOR

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

Capacity Update October 2024: Cell & Gene Therapy - WuXi Advanced Therapies

Capacity Update October 2024: Fill/Finish - Ajinomoto Bio-Pharma Services

Future-Ready Development - Landmark Bio

Cryopreservation Centers Of Excellence - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

Testing Solutions For Viral Vector-Based Products - SGS

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