Newsletter | January 23, 2025

01.23.25 -- Tune Therapeutics On Clinical Readiness, Technology Adoption

FOCUS ON OUTSOURCING

Tune Therapeutics On Clinical Readiness, Technology Adoption

Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

The Deep Roots Of Gene Therapy In Florida

Discover how Ascend builds on a legacy of AAV innovation in Florida, advancing gene therapy with cutting-edge expertise, GMP manufacturing, and deep academic collaboration.

Biotech Banter: The Realities Of Manufacturing

Experts discuss automated processes, “platformization,” moving early-stage companies into a commercialization structure, and how the industry can support academics developing these processes.

Overcome The Challenges Of Designing A QC Program For New Modalities

Stringent QC release testing throughout biologic production, as mandated by health authorities, ensures product safety and quality through evaluations of identity, purity, potency, and critical quality attributes.

Improving Pre-Clinical Study Efficiency With mRNA-LNP Technology

Uncover how Repair Biotechnologies, in collaboration with Vernal Biosciences, helped to pave the way for the next generation of breakthrough treatments for cholesterol and aging-related diseases.

Leveraging Platform And Process Characterization Data

Accelerate the delivery of cell and gene therapies by adopting streamlined validation and leveraging strategies that reduce timelines and support sustainable, compliant manufacturing pipelines.

Adapting An Adherent hCK Cell Line To A Serum-Free Suspension RCB

Learn about the development of a serum-free suspension MDCK cell line that serves as an optimal platform for isolating human influenza viruses from clinical samples and producing vaccines at scale.

Conduct Early-Phase Studies To Improve Manufacturability, Mitigate Risk

While clinical efficacy is the critical benchmark for any drug program, ensuring manufacturability is also vital. An experienced CDMO can help you establish efficient and cost-effective production strategies.

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.

Simplifying Outsourcing For Complex Formulations

Explore the necessary components of a tech transfer for LNP-based drugs, including the outsourcing strategies needed to avoid pitfalls.

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.

OUTSOURCING SOLUTIONS

Advance CGT With Scientific Insights Across Every Stage Of Development - Labcorp Cell and Gene Therapy Solutions

Capacity Update October 2024: Cell & Gene Therapy - Andelyn Biosciences

POSTmark™ CAR-T - Landmark Bio

Testing Solutions For RNA-Based Products - SGS

Groundbreaking Cryogenic Freezer Technology - Cryoport Systems

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