Issue link: https://www.e-digitaleditions.com/i/1492687
26 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook 2023 PharmTech.com Manufacturing another CMO as the previous partner may be unwilling to divulge full knowledge, as mentioned previously. Details that need to be shared include information on the analytical and process needs, as well as safety—and the more information that is shared, the less work the receiving site needs to repeat. When transferring from a sponsor to CMO, it is best to establish a good working relationship between parties, with good communication at the project management level, with an early agreement on requirements and expectations. Ideally, this relationship should include dialogue between scientists with experience of the pro- cess at the sponsor company and those undertaking the project at the CMO. Hanenberg (Recipharm) and Powell (Arranta Bio, a Recipharm Company): Transparency during informa- tion transfer is key to project success. This means that all process documentation for successful runs should be transferred, as well as for known failures and challenges encountered by the sending unit. During project set-up, any opportunity for the tech- nical team from the receiving site to observe processes at the sending unit can also support optimum knowl- edge transfer, increasing the chance of success. The receiving site should also perform engineering runs under observation by peers from the sending unit to confirm the process. In doing so, both parties can en- sure any yet-to-be-documented process knowledge is captured and transferred. Ercoli (BIOVECTRA): Best practices are not only sci- entific, they're organizational. Establishing the struc- ture of the transfer teams and getting the scientists and engineers to discuss the specifics of process de- velopment from the outset ensures a smooth transfer. For small companies, this will be a discovery process heavily reliant on the CDMO. The CDMO needs a gov- ernance process to measure milestones and timelines, as well as a process to escalate issues from engineers all the way to the executive level, if necessary. Smooth tech transfers benefit from plenty of face-to-face time during preparation. Dieterich and Mocny (Abzena): The devil is always in the details when it comes to tech transfer. Transpar- ent communication with precise and accurate detail between the transferring parties is essential to achieve the best results. A curious scientist will always look to fill the gap if they feel data [are] missing, and there is a risk of reinventing the wheel if the technology is not provided in the best format. Encouraging scientists to openly communicate with each other and understand each other's working environments helps with technical understanding and builds trust and relationships. Thassu (LGM Pharma): One important practice is to have a checklist consisting of prior experience-based documents, which are critical. Not a long laundry list, but a list with essentials (e.g., product specifications, product development report, batch manufacturing re- cord, ANDA/NDA [abbreviated new drug application/ new drug application] submissions, etc.) that will help the CMO understand what needs to be done and what needs to be looked at. Also, tech transfer should be done by the technical group, not the business development group (although they may have more of a relationship with the CMO). The technical group, which consists of R&D, regulatory/CMC, and quality teams, have the expertise to answer techni- cal questions from the CMO. This will reduce transfer time and support a smoother transfer, with little risk of knowledge getting lost in translation. PharmTech: How closely should sponsor companies look at tech transfer when choosing a CMO or CDMO? Hanenberg (Recipharm) and Powell (Arranta Bio, a Recipharm Company): Tech transfer is mission-crit- ical because it encompasses the handover of knowl- edge and the development of a robust process that fits within the manufacturing capabilities of the receiving CMO or CDMO. Pharma companies should always look closely at the tech transfer processes and capabilities of a potential partner when selecting a new CMO or CDMO to support their projects. A strong tech transfer function with a clear line of sight from program kick-off to commercial manufacturing can help them ensure the success of their development and innovation. Thassu (LGM Pharma): Very closely. Tech transfer is a crucial part of pharmaceutical development, and if you don't have a system or SOPs in place, or a proper techni- cal/analytical group working on the transfer, you are bound to make mistakes that will cost you money and a lost opportunity. There are a number of variables which a sponsor should look into when choosing or changing a CMO, but most importantly, the technical team should take leadership to minimize mistakes. From my experience at large to mid-sized pharma companies, and now at LGM Pharma, which is a CDMO, project management also plays a critical role in preventing failures and man- aging timelines during tech transfer. Dieterich and Mocny (Abzena): It should be acknowl- edged that at some point during the drug development process, technology transfer will be required—be it for GMP manufacture to enable first-in-human studies or to a larger scale to satisfy the increasing demand for a block-busting drug. With this in mind, the sponsor should try to select their chosen partner to meet their priority, skills, and experience requirements. Sponsor companies must also understand how far the prospec- tive provider could take their product. Having the pro- vider onboard and ready to help with the next transfer is always helpful. Ercoli (BIOVECTRA): The sponsor should only pro- ceed with a tech transfer once the process is completely