Newsletter | October 15, 2024

10.15.24 -- When Should You Select Your Supply Partner?

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Your Trusted Biologics Testing Partner

SGS Supports biopharmaceutical clients from discovery to clinical development and commercialization, through a comprehensive scope of expert-led quality control testing for raw materials, APIs, and finished products. Whether you need testing support through every stage of the drug development cycle or just when your in-house capabilities are limited, SGS serves as your trusted partner to support product characterization, method development and validation, bioanalysis and final GMP product release. Learn more.

FEATURED EDITORIAL

When Should You Select Your Supply Partner?

In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.

Keys To Successful CMC Source Document Preparation For CGT

Chemistry, manufacturing, and controls (CMC) source documents are the foundation for module 3 of a cell/gene therapy FDA regulatory submission.

If The CDMO Shoe Fits, Wear It Now

Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

Marriage Or Roofing Contractor? Metaphors For Outsourcing

Chief Editor Louis Garguilo instigates a bit of philosophic thought in panelists Sriram Naganathan, REVOLUTION Biologics, and Kirsteen Keith, Immunocore, when it comes to strategic alliances with CDMOs.

INDUSTRY INSIGHTS

Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy

We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.

Adopting Modular, Semi-Automated Approaches To Optimize CGT Development

There are a number of technology solutions that, when applied to a cell and gene therapy workflow, can streamline development and improve workflow integration.

Next-Gen rAAV: A Scalable Platform For Gene Therapy Manufacturing

See how a next-generation rAAV production platform delivers high yields and superior product quality across various serotypes and genome lengths through innovative process optimization.

Quality Management Systems: Implementation Strategies And Compliance

A robust pharmaceutical quality system is pivotal in achieving safe and efficient drug manufacturing. Learn more about its importance and the optimal methods for implementation. 

3 Fundamental Services For Superior Master Cell Bank Management

The integrity of your master cell bank (MCB) is paramount key in the production of advanced therapies. Selecting a provider with specialized expertise, optimal storage facilities, and meticulous record-keeping is crucial.

Accelerating Treg Therapy Manufacturing

The integrity of your master cell bank (MCB) is crucial for advanced therapy production. Choosing a provider with specialized expertise, top-tier storage, and precise record-keeping is essential.

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.

SPONSOR

Partner Week is back this October! From 10/21 through 10/25, hear from CDMOs across Fill/Finish, Large Molecule, Small Molecule, Cell & Gene, and our newest addition: ADC. Bring your questions and requirements, skip the small talk, and get right down to the business of finding the best-fit partner for your short- and longer-term drug development needs. Register for free at this link.

SOLUTIONS

Codex HiCap RNA Polymerase

This revolutionary enzyme delivers enhanced safety, cost-effectiveness, and performance, empowering researchers to unlock the full potential of mRNA therapeutics.

Vernal Biosciences Capacity Update May 2024: Cell And Gene Therapy

Examine our platform analytical and process technologies designed to accelerate the development of your cell therapy, gene therapy, or vaccine drug product.

Genomics Experience In Oncology

Discover comprehensive genomics solutions to advance your clinical trials, with tailored support from expert teams, state-of-the-art technologies, and a focus on oncology and beyond.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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