05.10.22 -- Inside FDA Draft Guidance On CMC For Individualized ASO Therapies

Deciding the best path forward to manufacture and commercialize cell and gene therapies means determining whether to partner with a CDMO or to build the development and manufacturing capacity in-house.

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and in clinical trials — all from one partner.

To provide a smooth transition from the lab to a CDMO, there are important factors you must first understand and steps to take prior to searching for and engaging with an external partner. 

In this study, we aimed to understand and quantify the levels of impact of cell therapy manufacturing but also to heighten our awareness of such impacts in years to come.

We show CRISPR/Cas9-mediated knockouts (KO) of the T cell receptor (TCRɑΒ) and explore multi-step LNP engineering to produce TCRɑΒ KO CAR T cells, a promising approach toward allogeneic CAR T cell therapy.

In building your new drug program, investors are betting on you to effectively manage development. Answering their questions well increases the likelihood of receiving support for your company’s vision.

The performance of the VIA Thaw CB1000 is compared to thawing in a water bath. The VIA Thaw™ dry thawing system shows comparable performance to a water bath with less handling.

See the industry’s NAS success stories: new chemical or biological entities where the active ingredient had received no prior approval for human use. 

Cloning efficiency is often overlooked in the cell line development workflow relative to the single cell isolation step. However, recovery and growth of the single cells is a challenging step in the process.

A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Discover what happens in this case study.

Achieving appropriate scientific oversight and thorough and efficient sample management throughout studies are challenges that many pharma and biotech companies encounter. In this Q&A, explore a highly specialized outsourcing model that address these challenges.

With a growing pipeline of traditional and regenerative biopharmaceutical drugs and increasing approvals for novel biologics and biosimilars, we need readily available development solutions.

In this webinar, experts discuss how enriching oncology clinical trials with RWD generates deeper insights and improves operational efficiency to achieve better patient outcomes.

Walk through the four primary challenges to In Vitro Diagnostic Regulation (IVDR) conversion and discover solutions to simplify and de-stress the process so that IVD manufacturers can approach deadlines confidently and avoid having products pulled from the market.

Explore case studies for neuromuscular degenerative indications, AAV technology and manufacturing, and strategies for navigating the regulatory environments in the U.S. and Europe.

Standardization via automation and introduction of quality control via closed systems in cell and gene therapy manufacturing will contribute to overcoming barriers and facilitate the reach of this treatment to broader patient populations. In this webinar experts discuss drivers and challenges associated with decentralized manufacturing and how streamlined processes can enable scalable point of care. Gain insight on closed, modular, automated cell therapy workflow solutions.