Successful Technology Transfer

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2019, Volume 43, Issue 4
Pages: 55

Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.

Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.

Preparing for a tech transfer

PharmTech: What are the first steps that should be taken when starting the process of tech transfer?

Bowles and Kiewel (Cambrex): The early transfer of information between companies is critical to a successful process transfer. At the RFP [request for proposal] stage, the receiving site should review the information provided and set up a teleconference to fully define the goals of the transfer and discuss the information provided in detail.  The discussion between the technical staff on both sides helps to fill in any gaps in the information and to eliminate any ambiguities in the RFP and assumptions in the proposal.  Early alignment between parties allows a proposal to be tailored to the precise goals of the program and reduces unnecessary back-and-forth during the proposal generation process.  When possible, representatives from the receiving site should travel to the sending site in order to witness key operations first hand.

Croucher (Catalent): The first step in allowing for a successful tech transfer is to evaluate the overall organizational impact in terms of operations, analytical, and quality. Then, the customer should provide a robust technical transfer information packet to the contract development and manufacturing organization (CDMO) to ensure all pertinent information is shared. Where a robust information packet is not available, a risk management approach and governance reviews become even more important. This information packet will include GMP [good manufacturing practice] batch records, special processing items (i.e., there are important processing steps that can be gained by talking to the actual operators, scientists, and engineers that played a role in the initial work performed, then these items are critical pieces of information that can make the difference in having a successful tech transfers), development reports (ranging from small lab-scale), and specific methods, such as in-process moisture, excipient release, and finished process testing. Equipment variability is also important (like-for-like equipment may or may not be available); working with a CDMO that has the experience in accounting for such variability, ensuring that the right size of equipment is available, and that the operating procedures for the specific project are confirmed as suitable and/or revised is a key element to a successful tech transfer.

PharmTech: Should both entities be involved in developing the tech transfer process?

Croucher (Catalent): Yes. Subject matter experts (SMEs) from the transferring site and the recipient site should be a part of the handover teams. In my experience, most successful transfers involve an intermediary from the transferring site to ensure the successful transfer of documentation, etc. The technical team from the customer’s company have the knowledge of the product and processes involved, while the CDMO’s technical team understands the available site infrastructure capacity, technologies, and equipment. Marrying these two groups, and their areas of expertise, is critical to a smooth transfer and a shared understanding of the product.

Sponsor companies will often have to consider many factors before they decide whether to produce a product in-house or to outsource. This decision may include factors such as how their global assets are being utilized, how efficiently they can produce now and in the future, and whether their own manufacturing network or that of an external contract manufacturing organization (CMO) or CDMO offers the better scalability to meet the sponsor’s aspirations for the product. The period before work commences, sometimes referred to as the planning horizon, therefore may be much greater for internal transfers than it is for the CMO or CDMO and can even be considered strategically by the sponsor company. If the decision is to use an external vendor, then an assessment or selection process is required to choose the correct partner, and that will often include an evaluation of what efficiencies or other benefits can be expected by outsourcing. This, in turn, requires some degree of disclosure to potential partners, and careful assessment by the sponsor company. Commercial terms need to be reached and, of course, an agreement to be made on how the tech transfer process teams will work together, including detailed comparisons of how policies and procedures compare. This naturally takes time and careful planning and may lead to the program starting later than it may have for an internal transfer.

Bowles and Kiewel (Cambrex): The receiving site should drive the transfer process, as it will ultimately be responsible for adherence to internal SOPs [standard operating procedures] and the final outcome of the transfer. The manner of transferring a specific technology or process from site to site should not be developed in an ad-hoc manner, but instead by following a clear, well-defined, SOP-driven method, regardless of whether the transfer is within a company or between a sponsor and CDMO.

Inter-company transfers should start at the early development stage with an understanding that the process is being developed for transfer to a known inter-company site, and unit operations should be developed with the full knowledge of both sites’ capabilities. Additionally, analytical methods should be developed for instrumentation which has been harmonized between sites in order to streamline method transfer. 

Best practices and challenges

PharmTech: What are some best practices and challenges in technology transfer, and how are these addressed? Are there specific considerations when it comes to large-molecule products/processes versus small-molecule?

Bowles and Kiewel (Cambrex): One of the key challenges facing technology transfer for manufacturing is the difference between equipment and specific reactors at different facilities. For internal transfers within a company, standard practice should be that the development work done at the developing/sending site is carried out with careful consideration for the equipment capabilities of the receiving site-a true one-company approach.

Croucher (Catalent): Time-to-market constraints can be challenging, as can insufficient documentation of processes, and key equipment capabilities. The main way to overcome these challenges and ensure a successful tech transfer is by establishing open communication streams between the sponsor and the CDMO, along with regular project reviews and updates. Having strong project management and technical teams will help move the project along to completion efficiently too, because the collective wisdom and experience of the team can overcome most problems given enough notice. While timelines are a key driver to product development, small investments in process improvement or early formulation development to improve product performance can lead to substantial savings later, as well as reveal opportunities for improved market positioning. Given the number of products a CDMO works on every year, innovators should expect their CDMOs to provide thoughtful input into development throughout the life of the product.

The key to any successful tech transfer is the understanding that each molecule is unique and will have its own set of challenges. How a CDMO prepares for any foreseen and/or unforeseen challenges can determine the molecule’s success. Utilizing a risk management approach throughout each stage of the project will assist in airing, addressing, and overcoming challenges as the program moves through each phase of its introduction and throughout life.

Article Details

Pharmaceutical Technology
Volume 43, No. 4
April 2019
Page: 55

Citation

When referring to this article, please cite it as S. Haigney, "Successful Technology Transfer," Pharmaceutical Technology 43 (4) 019.