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.

Because this process is so fundamental to what we do in support of our clients, we’ll be devoting this and a series of blog posts to a deep exploration of technology transfer, looking at what it is, how to make it successful, ensuring a smooth process with project managers, the cost of tech transfers, successful due diligence when in-licensing projects, how process validation guidance simplifies tech transfer and much more.

In our vocabulary, a technology transfer is what happens when a pharmaceutical company wants to change from an existing manufacturing site to a new manufacturing site, from one process train to another process train, or from one facility to another. Because manufacturers often have multiple buildings on a single campus, a technology transfer can simply be a move from building to building.

Assuming that the raw materials and active pharmaceutical ingredient (API) remain the same and are procured from the same supplier, a technology transfer begins with an assessment of the original manufacturer’s information — from raw materials through critical process parameters — followed by performing equipment, backsides, and comparisons according to scale-up and post-approval change (SUPAC) guidelines.

SUPAC Guidelines and Regulatory Strategy

The FDA’s SUPAC guidelines identify the types and specifications of equipment available for different pharmaceutical manufacturing functions. For example, milling equipment can be organized into several different classes, from V-blenders to ribbon blenders to bin blenders; SUPAC charts allow efficient comparison between the various classes of milling equipment. Ideally, equipment should stay within the same class or sub-class, eliminating unnecessary variables and reducing the number of questions that may come up during FDA pre-approval reviews and annual reports.

Developing Protocols

Assuring-Pharmaceutical-Technology-Transfer-Success-eBookAlways strive to develop transfer protocols in such a way that critical steps and machine differences are adequately challenged. It may be necessary to develop new operating ranges for the product, in which case one or more batches may be required at this stage. Remember, the more rigorously a process is challenged in this early phase, the more robust that process will be moving forward.

A strong process means reproducible quality, which in turn means fewer rejections down the line. When you’re confident that you’ve nailed down the process, you can move through the steps of validation. Provided that no issues arise during testing and the validation report is approved, the product may be considered releasable for sale.

Four Key Items

During the technology transfer process there are numerous aspects of production that need to be thoroughly challenged. Here are four key items:

A health and safety review This needs to be conducted to ensure the ability to safely handle the product.
Packaging line trials If a product is a new SKU to the site, it is crucial to perform line trials, filling the product into the proposed bottle or cap.
Stability indicating methods These should already be in place, enabling onsite transfer against the approved protocol.
Cleaning validation This needs to be assessed; specifications and bath records need to be written.

At this point in the process, operators can be trained and quality assurance agreements (which define the respective responsibilities between parties) should be enacted. All parties must connect to ensure that timelines are being adhered to and critical events and issues are communicated. For a successful technology transfer, a dedicated team of subject matter experts around the table discussing cross-functionally can often make the difference between success and failure.

Next Time: Part 2 — The Ins and Outs of Technology Transfer

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Topics: technology transfer

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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