Issue link: https://www.e-digitaleditions.com/i/1499694
www.biopharminternational.com Partnerships for Outsourcing eBook May 2023 BioPharm International ® 37 Tech Transfer 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 BioPharm: 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 ability to troubleshoot prob- lems may be limited. For example, a transfer could involve a program to install and run on a bioreactor 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 Dynochem allows modeling for scale-up of synthetic processes, as well as other tools that can assist in a tech transfer. These include safety modeling to support hazard evaluation assessment, design-of-experiment sof t ware, and modeling to understand qualit y led operating parameters, as well as statistical analysis programs that can help to understand process performance through tech transfer 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 industry 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. ■ Ajinomoto BioPharma Services ......................................................................................................................................................................................... 29 Avid Bioservices, Inc. ............................................................................................................................................................................................................ 7 BioVectra DCL ...................................................................................................................................................................................................................... 13 Catalent ................................................................................................................................................................................................................................ 38 Curia ....................................................................................................................................................................................................................................... 3 Jubilant HollisterStier Contract Manufacturing ................................................................................................................................................................ 19 Yposkesi ................................................................................................................................................................................................................................. 9 Ad Index COMPANY PAGE