INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Cell And Gene Therapy Bioprocessing: Hiring And Capacity Crunch On The Horizon

  With a very healthy R&D pipeline of cell and gene therapies, we can expect multiple blockbuster products and various “orphan” niche products to be launched annually in coming years. As a result, the industry is heading for a capacity crunch.

• Selecting The Right CMO For Your Gene Therapy

  Find out what criteria makes a great CMO partner and how to know if it is the right one for your gene therapy.

• Telltale Signs You’re With The Wrong CDMO

  Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

• Is Not Using A CDMO Slowing Down Your Process Development?

  Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

• Continuous Or Batch: Deciding On The Best Solution For Your Oral Solid Dose Product

  Gaining a better understanding of continuous manufacturing and its fitness for your OSD product could secure more control over the quality and safety of your product and, ultimately, the future of its success.

• Process Scale-Up And Scale-Out, Closure And Automation CDMO Services

  CCRM has extensive experience in closing and automating various cell therapy processes.

• Cell (iPSC ES CAR-T MSC NK) Process Development And Optimization For Commercial Manufacturing CDMO Services

  CCRM has deep experience in optimizing and developing processes for various cell types to ensure success during cGMP manufacturing. One example is the CAR-T process developed for a key international client, which is now being used to treat patients in clinical trials and with initial positive outcomes.

• cGMP Manufacturing Of Master/Working Cell Banks CDMO Services

  CCRM routinely manufactures cGMP master and working cell banks within our Centre for Cell and Vector Production. We can maufacture cell banks for use in USFDA, EMA, Health Canada and other jurisdictions around the world. Currently, we can manufacture cell banks up to 400 vials per lot and plan to increase our throughput and capacity in late 2020.

• 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).

• Cell Reprogramming And Gene Editing CDMO Services

  CCRM has extensive experience in cell reprogramming using a variety of gene editing tools to enable the development of iPSC and iPSC-derived therapeutics.