Issue link: https://www.e-digitaleditions.com/i/1492687
28 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook 2023 PharmTech.com every bit of know-how gets more securely transferred to the manufacturing and operations side. Dieterich and Mocny (Abzena): The best processes for internal tech transfer involve the right people with the knowledge and expertise needed to add value to the process. Defining the process through clear, doc- umented procedures guides scientists through this transfer. Teams should be encouraged to communicate proactively such that the receiving parties are made aware of any process idiosyncrasies ahead of time to plan risk mitigation strategies to overcome them. Automating transfer PharmTech: What kind of automation is used during tech transfer? Has this evolved over recent years? Ercoli (BIOVECTRA): One place where automation has proven immensely helpful is the ability to quickly share large amounts of data, especially as this can streamline transfers and allow troubleshooting of au- tomated equipment and processes. It is vital, however, that engineers receiving the transfer understand the process at a manual level, which allows insights into how to make improvements. If the process comes in an automated bundle, the abilit y to troubleshoot problems may be limited. For example, a transfer could involve a program to install and run on a bio- reactor or chromatography setup, but if an engineer doesn't understand how it was programmed, they won't know what's important or the sensitivity of the program (e.g., hold times, temperature, etc.). Rhodes (Sterling Pharma Solutions): Software such as D ynochem a l lows modeling for sca le-up of synthetic processes, as well as other tools that can assist in a tech transfer. These include safet y modeling to support hazard evaluation assessment, design-of-experiment sof t ware, and modeling to understand qua lit y led operating parameters, as well as statistical analysis programs that can help to understand process performance through tech trans- fer and scale up. Thassu (LGM Pharma): Automation has definitely changed and rightly so, especially as the biologics field is expanding and processes have become a thousand times more complicated. There's a lot more depen- dance on robotics, software, and IT. At LGM, we con- stantly use things like process f lowcharts and com- puter-aided designs to help identify which steps are critical and which are not. I believe these changes will continue at a rapid pace to meet the demands of the industr y and the chal- lenges of skilled labor shortages. It's becoming more critical to bring automation and IT into every part of the development process. Dieterich and Mocny (Abzena): Scientists dedicate many hours to setting up experiments, monitoring, gathering, and documenting data that can quickly fill lab books and journals. With the advent of databases and electronic lab notebooks, it has become easier to interrogate and make better use of this hard-won knowledge. As artificial intelligence advances, its ap- plication can help in the selection of lead candidates as well as predict pharmacokinetics, design clinical trials, and aid in pharmacovigilance. With further ad- vances in this technology, we will be able to accelerate the delivery of medicines to patients. Patki (Catalent): Catalent does not use advanced software for conducting process feasibility or facil- ity fit checks, as it mainly depends on the process, equipment suitability and availability, manufactur- ing site limitations, and process scalability. The f lex- ibility with technology transfer has increased over the years with new process equipment developed for supporting easy transfer of a process upon scale-up, and/or between sites. ■ Manufacturing Drug Digest: Automation in Biopharma and the Impact on Workflows In this exclusive Drug Digest video interview, Pharmaceutical Technology editors talk with Nick Pattinson, head of product at Automata, about the benefits of automating entire workflows in analytics (laboratories) versus automating only specific pieces of equipment or only certain processes. In this video, the following topics are discussed: • Additional automation approaches and how modular approaches fit into this • Automation opportunities in pharma (i.e., small molecule) vs. biopharma (i.e., large molecule) • Whether the level of adoption of automation differs in the industry between pharma and biopharma • How this trend toward automation in laboratory workflows impacts clinical and commercial drug development and manufacturing. Visit PharmTech.com to watch the interview. SCAN ME!