Issue link: https://www.e-digitaleditions.com/i/1492687
PharmTech.com Bio/Pharma Outsourcing Innovation eBook 2023 Pharmaceutical Technology ® 27 Manufacturing defined, unless they would rather have a CDMO define it for them. Tech transfers are a primary consideration when choosing a CDMO, as problems with commercial manufacturing will likely pop up if the transfer isn't conducted properly. Sponsor companies should choose a CDMO that is capable of considering all stages of drug development from clinical to commercial manufactur- ing, has experience with multiple modalities, and has extensive experience with regulators. The regulatory experience is particularly important. While a CDMO can provide guidance and work through many other problems, if the tech transfer and scale-up they've un- dertaken ultimately fails the pre-approval inspection, it can set the sponsor back months, if not years. Rhodes (Sterling Pharma Solutions): Primarily, sponsors should look for experience: a CMO must un- derstand the key project parameters to ensure efficiency. CMOs should also be transparent and willing to have open communication, have the resource and equipment available to suit the project, as well as technical exper- tise, and ideally, have a long-term vision for a program. This includes being willing and able to grow with proj- ects as they progress throughout their lifecycle, reduc- ing the need to undertake tech transfer again later in development/commercialization. York (Catalent): Sponsor companies should ask about the CDMO's experience with other transferred processes, for example, lessons learned. Without div ulging conf identia l materia l, t hey should be able to prov ide t i mel i ne goa l s a nd t he overa l l process comparability. Schemel (Catalent): It is very important for a spon- sor to consider the tech transfer process when choosing a CMO. Gaps in the tech transfer process lead directly to challenges on the manufacturing floor. A successful tech transfer with open dialogue between CMO and sponsor translates to operational excellence and the successful manufacture of drug substance. Internal tech transfer PharmTech: What are some best practices for inter- nal tech transfer either within a sponsor company or within a CMO? Rhodes (Sterling Pharma Solutions): Like any other tech transfer, there should be full disclosure of informa- tion: what works, but importantly, what did not work during development. There should be good alignment on practices and procedures, regular communication at the project management and peer-to-peer expertise level. This could also include secondment of staff to share real-life experience and gain eyes-on validation as project is trialed in a new facility. In the early stages of development, information on toxicological evaluation is important, both in terms of what data are available and when an update is likely. This will ensure appropriate containment is used. Additionally, the equipment used in synthesis and analysis should be as closely matched as possible to reduce the need for additional development and val- idation, and it is useful to share information on raw material suppliers, as different materials could impact a process with unknown impurities. Ercoli (BIOVECTRA): Internal tech transfers, in which one CDMO undertakes both formulation devel- opment and commercial manufacturing, can reduce risk, cost, and time to market. This is largely because of the value of transparency and ease of communica- tion between teams at the same CDMO. If the manufac- turing team runs into a problem with the process, they can directly access the development team, without being concerned about proprietary information that might hamper the sharing of information between the client and CDMO. Speed is especially important. While sponsors un- derstand the complexity of a tech transfer and want a CDMO to take the time to get it right, this is time for which they're not getting a return on their investment. Hanenberg (Recipharm) and Powell (Arranta Bio, a Recipharm Company): Best practice for an ex- ternal tech transfer applies equally to an internal trans- fer. The overall approach to the tech transfer should not change whether the sending unit is internal or external. Internal transfers provide an opportunity for an organization to align capabilities and share technical expertise of the process between internal sites. Shar- ing resources, whether personnel, materials, or docu- mentation between internal sites allows for additional assurance as to the comparability of the sites. York (Catalent): The most successful internal trans- fers to GMP are those that start very early in PD [pro- cess development]. Tech transfer teams from both GMP and PD work closely, with routinely scheduled meetings to discuss the progress of all projects. The teams review PD batch production records to learn about any potential equipment or process limitations going into GMP. New raw materials and components are identified and on-boarded prior to the engineering run in PD, so the bill of materials used at the start of GMP is identical. All these activities help fulfill a fa- cility fit (from PD to GMP). Thassu (LGM Pharma): To provide an example from LGM Pharma, one of the best practices we've imple- mented is to incorporate the tech transfer group within the R&D department. The simple reason here is what I like to refer to as 'mother knows best about the baby'— the drug product is R&D's 'baby'; it was developed in this department and all the expertise around the product lies there. So, tech transfer becomes a very straightforward process. They are all scientists and they speak the same language, be it material proper- ties, pharmacology, chemistry, or engineering. There's less likelihood of things getting lost in translation, and