Issue link: https://www.e-digitaleditions.com/i/1492687
PharmTech.com Bio/Pharma Outsourcing Innovation eBook 2023 Pharmaceutical Technology ® 25 Manufacturing be unwilling to share information with a competitor, only offer the bare minimum details, and be reluctant to answer any follow up questions. Dieterich and Mocny (Abzena): Oftentimes, the CMO ecosystem must be used to ensure the widest scope of skills and expertise are applied to get a pro- gram to patients. Whether from sponsor to CMO or CMO to CMO, a key factor in tech transfer success is the willingness of the source to be collaborative and to share information freely. Customers, therefore, favor transparency during tech transfer and, as it is generally considered necessary to set their program up for success, it's no surprise that many customers consider this trait non-negotiable. Reliable CMOs that are deeply skilled in effective tech transfer not only offer expertise but transparency. Hanenberg (Recipharm) and Powell (Arranta Bio, a Recipharm Company): There are unique challenges with every tech transfer, whether the sending unit is a sponsor company, a different CMO, or a different site within the same organization. Robust information transfer protocols are critical to set up the programme for success. CMO-to-CMO transfers can present additional chal- lenges in the information transfer phase as there may not be the same level of data transparency as with a sponsor-to-CMO or site-to-site transfer. The sponsor company may not have the manufac- turing experience for the program, meaning addi- tional support may be required to identif y and im- plement the required infrastructure and processes at the receiving site. PharmTech: Does tech transfer happen between con- tract research organizations (CROs) and CMOs? What is the process for transfer of information and product from clinical research to manufacture and distribution? Thassu (LGM Pharma): It depends on the product. For most small molecules, it may not be necessary because the CRO may not add much value to manufacturing or distribution. CROs do engage in several areas of impor- tance in the electronic Common Technical Document (eCTD) submission—for example, bioequivalent studies, but these don't typically need to be transferred to CMOs. But for biologics, it's a different ball game—there may be certain information (molecular biology knowledge and other critical process information) that a CRO identifies and has to transfer to the CMO, such as the source of a monoclonal antibody or mRNA. Ercoli (BIOVECTRA): Drug innovators, whether they're a CRO, biotech startup, or university—even some pharma companies—usually need the support of a CDMO to scale up their promising molecule to commer- cial production. The CRO transfers all the information from its benchtop trials and small-scale production to the CDMO's manufacturing team. This is followed by detailed communication at the scientific level to ensure the CDMO understands the process and the intent. The CDMO then takes this and scales up to commercial pro- duction. The majority of the CDMO's work happens here, in large part because of potential issues with scale that can be challenging for the innovator to anticipate. Dieterich and Mocny (Abzena): Tech transfer activ- ities regularly happen between CROs, CDMOs, and the sponsor. The objectives for pharmaceutical product lifecycle management and pharmaceutical quality sys- tem requirements are defined in the ICH [International Council for Harmonisation] Q12 and Q10, respectively. Both guidelines emphasize maintaining a state of con- trol over the product and the knowledge base. Although knowledge transfer is a continuum, it may look different depending on the sending and receiving parties. An effective transfer is driven by the receiving team (e.g., QC [quality control], QA [quality assurance], development) through a regimented process and de- fined deliverable list. CROs and CDMOs should imple- ment gap and risk assessments to capture all transfer needs and provide regulatory-compliant documentation describing this process. Hanenberg (Recipharm) and Powell (Arranta Bio, a Recipharm Company): Yes, tech transfers can happen between CROs and CMOs. In order for the transfer to be successful, planning should begin as early in the devel- opment process as possible. A line of sight to manufac- turing is essential when evaluating the design space to define process parameters and critical raw materials. While this information may not be available from the CRO, maintaining communication with the CMO is es- sential in order for the CRO to play its part in developing a process that meets the manufacturing capabilities of the receiving site. Best practices in tech transfer PharmTech: What are some best practices for tech trans- fer from sponsor to CMO or from CMO to CMO? York (Catalent): First, a need to have well-defined transfer process description is essential, which usually requires comprehensive communications starting right from project kick-off. These [descriptions] outline the information requests, operation, methods, and technol- ogy details. Then comes to the discussion on facility fit with risk/gap analysis, followed by 'deep dive' gap anal- ysis of process and method, which includes operation, material, method procedures, and partner alignment. The third consideration is GMP [good manufacturing practice] execution readiness, where analytical methods and standard operating procedures (SOPs), and detailed process execution are discussed thoroughly. There are lots of other variables beyond GMP, such as data review and analysis, which are required to achieve best practice. Rhodes (Sterling Pharma Solutions): The key thing is to share as much information as possible, although this can be difficult when transferring from one CMO to