Equipment
Does the receiving site have the equipment required to run the process?
Tech Transfers – Streamlining the Network
Why AbbVie Does Tech Transfers
AbbVie has over 25 manufacturing plants within the network, producing AbbVie products around the clock. Additionally, there are over 150 third parties we partner with to make AbbVie products on our behalf. The breakdown of products each site manufactures is part of an overall strategy to ensure our patients will have the medicines they need, when they need them. But if that breakdown needs to change, how is that done? Enter, tech transfers—the method by which a manufacturing process is brought from one site to another site. Before we dive more into what a tech transfer is, let’s look at how AbbVie evaluates what processes to transfer where.
Identifying the Need for a Transfer
During AbbVie’s Long Range Planning cycle, an assessment is done to evaluate the volume of product needed over the next 5 years compared to the network’s current ability to produce that volume. If there is a gap, a way to manufacture more product is required and this is often tied to transferring the process to an additional site. Additionally, as new products come down the R&D pipeline, they need to be transferred to a site for manufacture!
Selecting a Receiving Site
Once the need for a tech transfer is identified, the next piece is to determine which site will receive the transfer, internal or external? An assessment is done to determine which site(s) make the most sense, comparing numerous different variables, some of which are highlighted below:
Capacity
Does the receiving site have the capacity to run this process, along with current production?
Investment
Would transferring the process require significant capital investment at the site?
Manufacture Cost
How much would it cost per unit (of API, tablet, device, etc.) to manufacture at the receiving site?
Reasons for Transfers
There can be many reasons for initiating a tech transfer beyond ensuing the network can produce the required volume. Let’s take a look at a few other reasons:
Location
There can be strategic benefits to have a product produced within/near the market in which it is distributed
Assurance of Supply
Having a second site able to make a product provides a back up option if needed
Network Optimization
It can be more efficient for the overall network to shift where products are made to maximize site capacity usage
Elements of a Tech Transfer
Tech transfers are often governed by the QPP11-04 suite of documents in the AbbVie Quality System, and these spell out the key steps required to support a transfer. This not only helps standardize the process within AbbVie, but also helps ensure a successful transfer will meet all compliance requirements. Tech Transfers strategies have many elements to them, many of which are nuanced, but here we will highlight a few of the major buckets covered within the transfer strategy!
Product Transfer Strategy
When a process is being transferred from one site to another, assessments are done to determine what equipment and what batch size will be used. Sometimes a batch will either be scaled up or down based on the equipment’s capabilities.
Besides determining the scale of the batch, the transfer strategy also includes how many batches will be manufactured as part of the transfer. In general a transfer may include the following batches:
Development/Engineering = runs to finalize the process
Demonstration = essentially a dry run for validation
Validation (PPQ)
Safety Assessment
The EHS representative will assess what EHS related items are needed as part of the transfer to ensure proper controls are in place to protect our employees and the environment.
Analytical Strategy
The analytical strategy refers to identifying and transferring all applicable test methods associated with the process. These test methods are transferred as part of test method transfers (TMT) and occur at the receiving testing site (quality lab). Some example TMTs could be for:
In-Process & Release Testing
Incoming Testing
Cleaning Process Testing
Stability Testing
TMTs are required for all parts of a product: from raw materials, to drug substances, to the finished goods.
Regulatory Strategy
The Regulatory strategy is a key part in determining what submissions may be needed to which regulatory body, along with what specific requirements that regulatory body has for tech transfer and an estimate of how long that takes.
