Norm Fong

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.

Recent Posts

Introduction to Scale-Up and Post-Approval Changes (SUPAC)

Posted by Norm Fong

Scale-Up Blog Series, Part 2

[Editor’s note: Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. This is part 2 of an in-depth, multi-part series on product scale-up. Visit our blog page to read part 1.]

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Topics: scale-up, Pilot Batch, Process Development, SUPAC, batch, Documentation, Stability Testing

Practical Considerations in Pharmaceutical Production Scale-Up

Posted by Norm Fong

Scale-Up Blog Series, Part 1 

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook

From first-in-human and through each of the clinical trial stages and into commercialization, scale-up of formulation design is a natural part of pharmaceutical development. At each stage of process development, the batch size increases, from laboratory-scale batches that may be quite small to support preclinical and early clinical stages, to pilot batches that are used in process development, and finally to the production-scale batches needed to support commercialization.

Not surprisingly, the size, speed and power of the equipment involved in production has a significant impact on the entire process and must be matched to the batch-size requirements for production efficiency. Regardless of the size of the batch and its application — for use in clinical trials and stability testing, to service a smaller patient population with an orphan drug, or to provide for a larger population with a commercial product — the object is always the same: the finished product must be identical to the original formulation design regardless of the volume under which it is was produced.

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Topics: scale-up, Pilot Batch, Validation Batch, Process Development, SUPAC, Registration Batch, Feasibility Batch

Part 7 — How Does the FDA's Process Validation Guidance Simplify a 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 7 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: qualification, PV, process validation, IQ, FDA guidance, OQ, PQ

Part 6 — In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully

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 6 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: due diligence, excipients, development reports, in-licensing, API, complaint history, USP standard

Part 5 — The Cost of Getting a Technology Transfer Right

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 5 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: MSA, confirmation/demonstration batch, QA, Regulatory site audit, capital expenditure, legal fees

Part 4 — How are Analytical Methods Exchanged in a 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 4 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: CMO, analytics, analytical method transfer, chemical analytics, validation

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.]

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

Part 1 — What is a Technology Transfer and How to Ensure a Successful Transfer

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

Current market conditions, as well as a myriad other factors, have increasingly prompted drug developers to establish complex supply chains to ensure the commercial-scale manufacture of the compounds they’ve created. Perhaps one of the most important links in any contemporary supply chain is the one between drug owners and the contract manufacturing organizations (CMOs) they partner with to ensure that supply will meet the demand for their therapies. When it comes to these relationships, success hinges on several critical factors, but chief among them involves getting a highly critical process right: the technology transfer.

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Topics: technology transfer

Principles of Technology Transfer

Posted by Norm Fong

In the context of contract drug development and manufacturing, transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.” It is the systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible party.

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Topics: Manufacturing Scale-Up, technology transfer, site-to-site, site-to-CMO, site transfer