GMP facility – feasibility study for biologics production

Drawing on expertise from its regulatory, gene therapy and manufacturing consultants, Alacrita conducted feasibility study and formulated a business case for a new GMP facility for production of investigational therapies.

The client’s facility had established a leading position in Europe in the GMP production of cell therapeutics and viral vectors for gene therapy, and consequently had an extensive pipeline of prospective developmental products for both academic and commercial customers. With the expectation that market demand for clinical trials supply of cellular and gene therapies was due to increase dramatically over the coming years, driven by rapid growth in gene therapy, CAR-T Cell immunotherapy and other cellular therapeutics, the client wanted to develop plans to expand capacity and refurbish, and in the process look at the options for bringing in external capital.

Alacrita conducted a reality check and high-level due diligence exercise by interviewing key members of the client team to understand their customer base; capabilities and capacity; financials (actual and projected); development plans; any underpinning assumptions and projections; and the context and status of any discussions with prospective investors and the nature of any proposed transaction.

Our consultants then reviewed the technical plans to ensure there were no red flags, and then conducted an independent reality check of the development plans, based on a review of the materials provided, its knowledge of the market and competition in supply of GMP cellular and gene therapy therapeutics, focusing on:

  • The opportunity for the client and the sustainability of market demand;
  • The solidity of the development plans and the associated funding requirement;
  • The arguments for creating a commercial entity and involvement of external capital;
  • The prospective valuation of the entity and funding mechanisms.
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