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:
- Unavailable raw materials. The new site could have difficulty procuring the required raw materials or they could be inaccessible because of their location in another country. Also, there may be differences in the raw materials between different suppliers that could impact the project results.
- Different equipment. A specific project could require specific instruments, such as GMP-quality agitators, buffers or pressure filters that the new organization may not have, even slight changes in equipment can create different results.
- Changing regulations. Especially when transferring to different countries, there can be varying regulatory requirements that can impact methods and analytical processes, and add extra time to the project, which results in higher costs.
- Missing information. As with any transfer, much can be lost in translation. As information and documentation is transferred between organizations, a failure to leave out critical information can sideline the whole project.
Sticking with a Single CDMO Can Minimize Tech Transfer Risk
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.
5 Best Practices for Smooth Tech Transfer
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.
- Provide thorough documentation. All information, including method development, analytical procedures and critical quality attributes, roles and responsibilities, should be clearly defined throughout each process. This should also include documentation of deviations along with root cause analysis and corrective/preventative actions to ensure consistent process execution.
- Start with a solid plan. If you start with a plan that includes clearly defined roles and responsibilities, process and facility procedures and outcomes, this information can be shared as part of tech transfer to make sure the next organization is in alignment.
- Establish goals and timelines from the outset. When you begin a project with clear goals, expected timelines, costs and deliverables, all phases of the project, regardless of who is performing it, can work toward the shared goals.
- Insist on ongoing communication. With ongoing communication occurring between you, the CDMO and the transferring CDMO, there is no need for guessing if and when specific steps occurred or if problems arose. Even if you no longer are working with a specific CDMO, insist on their availability should questions arise regarding work they provided.
- Focus on safety. One of the most important aspects of process development is attention to safety. During tech transfer, conduct a meeting between the R&D team, engineering team and the health & safety team to determine possible dangerous points during manufacturing. Some chemicals can be hazardous to the operators who are managing the reactor vessels, so extra care must be taken to protect them.
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.