Part 2 — The Ins & Outs of Technology Transfer

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 2 of an in-depth, multi-part series on tech transfer. Visit our blog page to view Part 1.]

Technology transfer — the handover of knowledge between organizations — is the seminal event in all outsourcing arrangements, particularly for pharmaceutical manufacturing. Tech transfers may occur internally, within a company, externally, involving two or more corporate entities, or involve successive lifecycle stages, such as development and scale-up. External tech transfers prompt the most discussion, and contractors and sponsors have each developed their own unique tech transfer subcultures

The key to success is not allowing those subcultures to clash. This is the step where the CMO comes to understand, from the sponsor, the product’s critical quality attributes and known process control parameters within the scope of the customer’s business objectives. Once this occurs, a CMO should have a good idea of process design options, and a secondary step, internal technology transfer process from the process engineers to the manufacturing group. After selecting engineering and quality controls, engineering presents QA a development plan to ensure consensus.

Common Misalignments

Because CMOs often work with many different products and technology platforms, manufacturing teams must possess deep understanding of good manufacturing process (GMP), and recognize potentially adverse process issues early enough to implement preventive actions.

A common misalignment between sponsors and manufacturers during this process involves deliverables. Sponsors unfamiliar with formal requests for proposal (RFP) fail to communicate their needs accurately and completely; contractors misinterpret poorly conceived RFPs and the result is widely varying bids with an “apples-to-oranges” comparison. PharmaDirections, which serves as an intermediary between CMOs and sponsors, recommends including a demo or engineering batch into CMO contracts. It adds about one month to the project, but can help avoid much longer delays associated with a failed clinical batch.

Kickoff Meeting

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook

The best way to begin a tech transfer is with a tightly structured and documented kickoff meeting with the customer. During this consultation, the business partners assemble a detailed technology transfer list that includes everything required to initiate and understand the project. After the CMO has reviewed the sponsor’s documentation package, a “technical kickoff” meeting is initiated where the parties cover specific, anticipated chemical/engineering issues.

Bottlenecks occur when the sponsor does not or cannot provide a robust data package. Sponsors may not fully understand tech transfer and the CMO’s expectations. Many small sponsors lack GMP, regulatory or analytical experience, and may underestimate their significance. This assumes that the CMO is prepared to explain the sponsor-specific activities required that it may not have anticipated before the tech transfer.

CMO-to-CMO

When a process transfers from one CMO to another based on production scale, capacity, scheduling, or some dissatisfaction with the first contractor, disjointed communication can occur when the product owner and two CMOs are involved. Even when everyone cooperates and is well-informed, involving three parties rather than two is inherently confounding. In some instances, the innovator and the first contractor have intellectual property to protect surrounding the product, proprietary know-how, or patented technology that they prefer not to share.

If you want to get a technology transfer off to a great start, it is imperative to avoid disjointed communications on both the transferring and receiving sites. Starting off with clear and open dialogue between the two parties will reduce potential clash in the subcultures and ensure a smooth handover of knowledge between the organizations.

Next Time: Part 3 — Ensuring a Smooth Start with Project Managers

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Topics: CMO, technology transfer, process design, GMP, quality controls, scale-up

Norm is the technical transfer manager, business development, for WellSpring. He has over 21 years in the pharmaceutical manufacturing industry and has held development, transfer and commercial manufacturing positions over the course of his career with Patheon, Global Pharm (formally Pharmacia Upjohn) and Genpharm (owned by Merck). Norm is responsible for overseeing technology transfer and all validation activities in the organization.

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