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Gene & Cell Therapy
Advanced therapies where the regulatory path is still being written, the manufacturing is the product, and the people who have done it before can be counted.
The problem
For a small molecule you can characterise the product and control the process loosely. For an autologous therapy you often cannot fully characterise the product at all, so control shifts almost entirely onto the process, the facility and the people running it. Every deviation becomes a potential product impact rather than a paperwork exercise.
That would be hard enough with a mature talent market. There is not one. The number of people who have genuinely run a batch-of-one manufacturing quality system, or defended a potency assay to a regulator, is small, and the companies competing for them are well funded.
Speed of access matters more here than anywhere else we work. When a real specialist becomes available, the window is days, and it closes whether or not your requisition has been approved.
Tell us the problem. A specialist replies, not a form robot.
What we do
Quality and operations resource for chain of identity and chain of custody.
Analytical specialists for the assays regulators question hardest.
RMAT, PRIME and breakthrough designations, and the evidence they demand.
Batch-of-one manufacturing quality systems that still hold up.
Registry and pharmacovigilance support across extended observation periods.
Access to a pool most generalist recruiters cannot reach.
Days
The window when a genuine specialist becomes available
Client testimonials are being collected and will be published here once the clients concerned have approved the wording in writing.We do not publish quotes we have not been given permission to use.
Questions
We have a network in it, which is the honest answer. Nobody has a bench of available cell therapy quality leads sitting idle. What we can do is reach the people who exist and move quickly when one is between engagements.
Both, though they are genuinely different problems. Autologous work is dominated by chain of identity and single-patient batch control. Allogeneic looks closer to conventional biologics manufacturing with harder comparability questions.
Yes. RMAT, PRIME and breakthrough requests are won or lost on how the existing data is argued rather than how it is formatted, and the commitments that follow need tracking from day one.
That transition is one of the most common reasons companies call us. The gap is rarely scientific. It is documentation, controls, and the discipline of doing exactly the same thing twice.
The same way as any other: an agreed rate against a rate card you sign off in advance. Scarcity moves the market rate, and we will show you what the market is actually paying rather than assert it.
Related
Judge us on the shortlist, not the sales deck.