Sponsor to CDMO, site to site
Technology transfer
A transfer plan that makes the receiving site reproduce your product, not an approximation of it.
Discuss your programmeOverview
Most failed transfers fail on knowledge, not equipment. Critical parameters live in the heads of two or three people, analytical methods behave differently in a new lab, and nobody agreed what success looks like.
We make that knowledge explicit, plan the transfer around the real risks and stay with the programme until the receiving site meets the acceptance criteria.
What we do
Transfer strategy and plan
Scope, timeline, roles and acceptance criteria agreed before work starts, so that sending and receiving teams are working to the same definition of done.
Process knowledge package
We turn development reports, batch records and tacit know-how into a document the receiving site can execute from.
CDMO selection and technical due diligence
Capability, capacity and quality-system review of candidate sites, with a view on technical fit rather than price alone.
Fit-gap and risk assessment
Equipment, materials, scale and facility differences between sites, with a mitigation for each real risk.
Engineering and PPQ-readiness runs
On-site oversight of engineering batches, and a clear view of what the data say before you commit to validation.
Analytical method transfer
Protocols and comparison studies that show the receiving lab gets the same answer, including potency and other complex assays.
When teams call us
- You are moving from a development lab or pilot plant to a CDMO for the first time.
- You are changing CDMO, or adding a second site for supply security.
- A transfer is running late and nobody is sure why.
- You are scaling up and need to show the product is comparable.
How it runs
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Assess
We review the process, the documentation and both sites, and identify what the receiving site needs to know.
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Plan
We agree the plan, criteria, responsibilities and communication rhythm with both parties.
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Execute
We oversee knowledge handover, engineering runs and method transfer, and escalate problems early.
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Confirm
We compare outcomes with the criteria and write the transfer report that supports your regulatory filings.
Common questions
Tell us what you are facing
A thirty-minute scoping call, no charge. We will tell you honestly whether we are the right team.