Tech transfer is a crucial phase that converts clinical promise into commercial gain but pressure on sponsors to reduce time to market in the age of COVID-19 means CDMOs have to be on top of their game to deliver. What are the latest innovations to solve tech transfer challenges?
Technology transfer is a critical step in any pharmaceutical or biopharmaceutical manufacturing and supply contract. The efficacy with which processing knowledge is passed from a drug developer to its contract development and manufacturing organisation (CDMO) will determine how effectively the contractor can service the agreement.
Tech transfer also impacts time to market, which is critical in terms of getting treatments to patients as quickly as possible and in helping drug companies commercialize products.
This point was emphasised in a recent report by McKinsey which suggested efficient and effective technology transfer was vital to efforts to combat the COVID-19 pandemic.
The authors said “Tech-transfer times for sterile dosage forms, such as injectable vaccines, range from 18 to more than 30 months…That will not be true for a COVID-19 vaccine or therapeutic. Society will demand the shortest possible timeline.
“Once a successful vaccine is confirmed, manufacturers will be under extreme pressure, and tech transfer will need to happen as soon as possible, within a few months.”
In addition, tech transfer also shapes how effectively production can be scaled-up, helping to identify the critical unit operations where investment would be required and letting both the customer and contractor find any other potential bottlenecks.
Over the past few decades CDMOs have developed strategies to facilitate streamlined technology transfer that can be tailored to the specific needs of each project. However, as the complexity of drug products and the processes needed to make them has increased, contractors have been forced to innovate.
Typical tech transfer
The World Health Organisation (WHO) defines technology transfer as embodying “both the transfer of documentation and the demonstrated ability of the receiving unit to effectively perform the critical elements of the transferred technology to the satisfaction of all parties and any applicable regulatory bodies.”
Likewise, in its Q10 guidance, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) stresses the importance of sharing product and process knowledge during the technology transfer process.
The focus of both guidelines is the efficient transfer of information. Typically, processes are split into several stages, beginning with the creation of a complete description of the product – including all source materials – followed by a feasibility study setting out the business case for shifting production.
The next stage is to create a detailed plan followed by the physical transfer of technologies and processes. Subsequent stages focus on identifying variations, registering the product with regulators, preparing for launch and reviewing the project.
SOP approach
To try and achieve this, contract manufacturers have developed generalized transfer protocols, according to a senior supply chain consultant at Orphan Drug Consulting: “Many CDMOs now have standard SOPs for tech transfer, as they should not be reinventing the wheel for each new tech transfer. A responsibilities matrix should be agreed and kept live that defines who within the client and the CDMO is responsible for what, e.g. analytical transfer, process transfer, cleaning transfer etc. Most importantly within this matrix are the two leads from both Parties.”
He adds that “for the CDMO it should be a dedicated Tech Transfer lead or Manager that manages the overall project team within a matrix. Following this, an agreed Tech Transfer Protocol should be ...
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