Newsletter | February 3, 2025

02.03.25 -- The Ins And Outs Of In-House Manufacturing: Building A Cell & Gene Production Facility

FOCUS ON OUTSOURCING

The Ins And Outs Of In-House Manufacturing

Deciding whether to bring manufacturing in-house or outsource it to a partner can be a daunting decision, particularly as market forces continue to put pressure on small biotechs.

A Stratified Approach To rAAV DNA Purity And Integrity Characterization

Explore our comprehensive methods for assessing DNA purity and integrity in AAV products to ensure the highest quality gene therapies for your patients.

Development Of A Universal, GMP-Ready, Clonal HEK293 Cell Line

When manufacturing adeno-associated virus, lenti- and adenoviral vectors, see how this HEK293 cell line is optimized for suspension culture and viral vector production, which can significantly reduce costs.

Developing An mRNA-Encoded Antibody Platform

In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.

Modular, Scalable AAV Purification Process For Safe Vectors

We encourage the adoption and further optimization of this scalable AAV downstream process platform to enhance gene therapy applications, ensuring high product yield, quality, and compliance.

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.

Plasmid Engineering To Improve AAV Productivity And Packaging Efficiency

Review how you can significantly increase AAV productivity and packaging efficiency for various AAV serotypes and client-specific Genes of Interest (GOIs) at the upstream production stage.

Expectations On The Pathway To GMP For Gene-Modified Cell Therapies

Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.

Preclinical And Clinical Development Of CAR T-Cell Therapies

Streamline CAR T-cell therapy development with integrated support for asset identification, IND submission, early-phase studies, and advanced real-time tracking solutions.

Enhancing 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.

OUTSOURCING SOLUTIONS

Enabling The Outcome In EMEA - Cryoport Systems

Seamless, End-To-End Cell & Gene Therapy CDMO - GC Cell

Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles - Battelle

Helping Cell Therapy Innovators Bring Treatments To Market - Kincell Bio

UpTempo AAV Platform Process - Catalent

Adeno-Associated Virus (AAV) Biosafety Testing & Characterization Services - MilliporeSigma

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