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Cell and Gene Therapy (CGT) Manufacturing Boom Roars Along

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With a swell of R&D activity flowing into the development of cell and gene therapies over the past decade, a manufacturing shortage gripped the industry. This caused industry participants to express grave fears that the manufacturing shortage would threaten industry growth and lengthen time-to-market for these new types of living therapies.

While there remains a shortage of skilled workers, the manufacturing capacity available to the cell and gene therapy marketplace has turned a proverbial corner, entering an era of prolific growth.

Aggressive construction of cell and gene therapy manufacturing facilities is now being undertaken by biotech companies seeking their own production capabilities, as well as by Contract Development and Manufacturing Organizations (CDMOs) who plan to serve third-party clients. [Read more…]

ElevateBio to Operate at a Hybrid CDMO and Investment Holding Group

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ElevateBio, LLCElevateBio, a newcomer to the cell and gene therapy sector, is taking a different approach than the competition. Founded only months ago in early 2019, the company plans to aggregate a portfolio of cell and gene therapy companies that will develop, manufacture and commercialize life-transforming medicines.

It has launched with an unusual business model, which is to be a hybrid CDMO for cell and gene therapy companies, as well as an investment holding company. It will accomplish this feat by offering “R&D and cGMP manufacturing facilities to be shared across several portfolio companies, each with a different disease focus.”

Key to ElevateBio’s plan is the construction of an R&D and cGMP manufacturing facility in Cambridge, MA, that it calls BaseCamp. The complex will act as a centralized research and manufacturing group to support a portfolio of promising cell and gene therapy companies, each which will have a different disease focus.

[Read more…]

Cell Therapy Manufacturing | Factors Driving Interest in Cell Therapy CDMOs

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Cell therapy manufacturing is becoming of growing importance as more and more cell therapeutics make their way through clinical trials. One of the major issues with moving cell therapy products from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing.

Cell Therapy Manufacturing CDMOs

While these realities may sound like negative factors for the industry, the reality is quite the opposite. For cell therapy CDMOs, these factors create pressures for cell therapy companies to seek third-party partners who possess technical, manufacturing, and regulatory expertise in cell therapy development and manufacturing. [Read more…]

SanBio’s Regenerative Medicine Product SB623 to Be Manufactured by Hitachi Chemical

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March 13, 2018 03:39, TOKYO — SanBio Group and Hitachi Chemical Co., Ltd. (Hitachi Chemical) jointly announced today that, through an agreement with Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS; formerly PCT Cell Therapy Services, LLC), Hitachi Chemical’s US subsidiary that engages in contract manufacturing and development of regenerative medicine products*1, they will manufacture SB623, a proprietary regenerative medicine product under development by SanBio. Under the agreement, late stage clinical products and commercial products of SB623 for the US and Japanese markets will be manufactured using Hitachi Chemical’s global facilities. [Read more…]

Key Strategies for Positioning Cell Therapy CDMO Services – Size & Specificity

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A contract development and manufacturing organization (CDMO), is a company that serves cell therapy companies on a contract basis. Common cell therapy CDMO services include cell therapy product development, manufacturing, clinical trial support, and commercial supply.

CDMOs allows cell therapy companies to outsource aspects of their business, which can support:

  1. Scalability
  2. Speed to market
  3. Adding technical expertise without overhead costs
  4. Cost efficiencies

[Read more…]

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