What Is A Technology Transfer In Pharmaceutical Contract Manufacturing?

Posted by Wellspring Pharma Services

10_cu_ft_V_Blender_for_tablet_granulationIn 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. More generally, it can also involve the move from one process train to another, or perhaps from one facility to another. Manufacturers often have multiple buildings on a single campus, in which case a technology transfer can simply be a move from building to building. In our particular parlance, a technology transfer always implies a move from some other manufacturer to our manufacturing site.

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 SUPAC guidelines.

SUPAC Guidelines and Regulatory Strategy

Scale-Up and Post-Approval Change (SUPAC) guidelines are a set of online FDA guidelines which identify the types of equipment available for different pharmaceutical manufacturing functions. Let's take milling as an example of a common manufacturing function covered by SUPAC documents.

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. During an ideal technology transfer, 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.

The more equipment that remains within the same size, class, and sub-class, the fewer issues that tend to crop up during the technology transfer process. Where there are differences, it can be helpful to challenge those differences to understand what impact they might have on the process and to demonstrate that they are in fact equivalent. Comparing each process side by side with the aid of SUPAC guidelines can both identify any potential differences and determine what those differences may mean during manufacturing.

Make Sure Transfer Protocols Are Developed To Capture The Process Thoroughly

Determining-Best-Manufacturing-Processes-Guide-For-Pharmaceutical-Products Always 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 thoroughly a process is challenged in this early phase, the more robust that process will be moving forward. A robust process means reproducible quality, which in turn means fewer rejections down the line. When satisfied that you’ve nailed down the process, it's time to move through validation.

Provided that no issues arise with testing and the validation report is written and approved, the product may be considered releasable for sale.

4 Key Items That Also Need To Be Challenged To Ensure A Successful Technology Transfer

Along the way, there are many items that need to be challenged; for example:

Tablets_Capsules_Pharmaceutical_Packaging

  • 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 should already be in place, enabling onsite transfer against the protocol signed off by the client.
  • Cleaning validation needs to be assessed, specifications and batch records need to be written.
  • A Health and Safety Review needs to be conducted to ensure the ability to safely handle the product.

At this point, operators can be trained and QA agreements (which define the respective responsibilities relating to the contracted GMP activities between parties) must be put into place. Numerous meetings along the way ensure that timelines are being adhered to, as well as critical events and issues are communicated. It is essential to have a dedicated team of subject matter experts around the table discussing it cross-functionally; this can often make or break a timely and successful tech transfer.

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Topics: Manufacturing Scale-Up

WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.

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