For a variety of reasons, pharma firms may find it necessary to transfer a development or manufacturing project from one site or firm to another, in order to address a new stage, changing requirements or scale-up. This is usually not a one-time thing, but can occur many times throughout the lifecycle of a drug. Different stages require different materials, methods and equipment, as well as changing and specialized expertise. Sometimes, things just don’t work out with a particular Contract Development & Manufacturing Organization (CDMO) and you decide to shift operations to a new one.
Regardless of why a tech transfer is required, there’s no getting around the fact that it can be somewhat disruptive to the project timeline and create some level of risk to the smooth drug development process. What exactly could go wrong? Consider the following:
Despite these challenges, there is a way to minimize the risk. An integrated CDMO can carry you all the way from the drug development and discovery processes straight through to commercial manufacturing. It can provide standardized GMP suites, processes and equipment that remains the same across its sites. In addition firms, such as Seqens, with operations across the globe, has access to more suppliers and partners, specialized expertise and equipment, and all sites conform to the company’s standardized processes, protocols and quality requirements. Seamless tech transfer can occur across our sites because we’re one unified company.
Integrated CDMOs are able to pool the expertise and experiences of a diverse range of professionals who can help address issues that almost inevitably arise when scaling up Active Pharmaceutical Ingredients (APIs). Because of the seamless hand-off they enable, integrated CDMOs help to keep projects on schedule without the major disruption that tech transfer can entail. Additionally, they can eliminate duplicate activities, and consequently costs, since processes don’t have to be validated each time a new organization works on a project.
While an integrated CDMO is a good way to go, that’s not always possible, but you can learn from their five best practices to ensure that tech transfer occurs as seamlessly and quickly as possible.
Tech transfer is a natural activity on the long road to drug product commercialization, but there are clear ways to avoid the stumbling blocks along the path. By reducing the number of organizations involved in the process, and setting clear expectations you often can avoid the delays, mis-steps and duplicated efforts that that can derail project timelines, add unnecessary costs and impact the continuum of quality your project deserves.
For other content on tech transfer, check out: Passing the Baton in API Development; or API Manufacturing Tech Transfer.