Newsletter | February 19, 2021

02.19.21 -- Cell & Gene Therapy Development CDMOs

Veroplex® Proprietary Vero Cell Platform

Need an established and validated platform to manufacture your vaccine candidate? Look no further than Ology Bio’s proprietary Veroplex Platform, comprised of proven Vero cells, patented processes for vaccine development and production, and experienced regulatory support.

A Viral Vaccine And Viral Vector CDMO

IDT Biologika provides contract development and manufacturing of live viral vaccines, gene and immune therapeutics, and fill/finish of biologics.

Catalent Cell & Gene Therapy, The Journey

In a little over a year, Catalent has expanded into the Cell and Gene therapy space through acquisitions. In this podcast you will hear from Colleen Floreck, Sr. Director, Strategy & Marketing, Cell & Gene Therapy, about Catalent’s journey into this exciting and growing space, overcoming challenges, and the company’s commitment to its partners.

De-Mystifying And De-Risking Process Development Through Early Engagement With A CDMO

An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.

Viral Vector Services Regulatory Offering Menu

The regulatory environment for Cell and Gene Therapies is evolving at a rapid pace. Many companies, especially new and emerging ones, often lack the internal resources, or expertise to support regulatory filings. Companies need a partner who continuously monitors the changing regulations and has the capabilities to support them with their regulatory needs. Patheon Viral Vector Services provides a comprehensive range of regulatory consulting services for the cell and gene therapy innovators.

cGMP Manufacturing Of Cell And Gene Therapies For Phase I & II Clinical Trial CDMO Services

CCRM's 40,000 sq-ft PD and cGMP manufacturing facilities are staffed with 120+ scientists, engineers, operators and support functions, with plans to grow the team by late 2020 to support increasing industry demand. We have experience in manufacturing for global clinical trials, and can provide both small-scale autologous and large-scale (200 L) allogeneic batches, as well as have scalable workflows. Our team can perform complex and highly customized manufacturing runs (CAR-T, T-cell, iPSC, NK, MSC, LVV, AAV).

Plasmid DNA

Aldevron is a responsive and reliable resource of plasmid DNA for research, pre-clinical and commercial use. 

Delivering Integrated Clinical Trial And Commercial Packaging Services

Sharp is a global leader in contract packaging and clinical trial supply services to the pharmaceutical and biotechnology industries. Operating from eight state-of-the art facilities across the United States and Europe, Sharp works collaboratively with pharmaceutical and biotechnology clients across the world to create unique commercial and clinical solutions for even the most complex drug products.

Process Transfer CDMO Services

Cytovance® has a 10+ year track record of successful technology transfer to support a wide range of biologics and clinical stages. Our core objective is to ensure that the contracted activities are well aligned with our clients’ objectives, whether they are focused on scale-up from early stage development phases to commercial manufacturing, expanding commercial scale to meet new market demand, or modifying the manufacturing process to improve process economics.