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www.biopharminternational.com Manufacturing and Facilities eBook 2023 BioPharm International ® 11 Manufacturing: Tech Transfer manufacturing to commercial manufacturing, having DP commercial labeling and serializa- tion capabilities allow for continuous manufac- turing at the same facility, which is a great ad- vantage in the biologics industry. This increases speed to market by eliminating a profit-and-loss event at a different vendor and the cost and time associated with a bulk shipping validation to a different site. Engineering batches to assess any change par ts required and studies to address product shear and impact of temperature on the product (time out of storage) are considerations. Data from mixing studies, pump speeds, filtra- tion schemes, and subsequent filter f lushing are critical at this stage of the process. CDMOs with joint teams of tech transfer, DP operations, and regulatory compliance conduct rigorous risk as- sessments, set the proper process parameters, and therefore, create a right-the-first-time pro- cess in manufacturing. • Robust supply chains: CDMOs must ensure reli- able access to equipment and DP contact pathway materials, such as single-use mixers with sin- gle-use systems (SUS) mixing bags, SUS filling assemblies, stainless steel, or a hybrid approach that includes raw materials and primary packag- ing. A proactive supply chain that is in constant communication with manufacturing science and technology (MSAT) and DP operations can with- stand change from outside inf luences to avoid long lead times for materials to successfully meet deadlines. Furthermore, CDMOs adept at closely collaborating with multiple suppliers may help ensure the on-time delivery of the final products by maintaining the stable supply line of raw ma- terials needed to assemble single-use containers through multiple vendors. On-time delivery Tech transfer allows product and process knowledge to be transferred between the sending site and the receiv- ing site on the journey to the clinic or to commercializa- tion, forming the basis for the manufacturing process, validation approach, control strategy, and continuous optimization. Having a clear understanding of both the product (critical quality attributes [CQAs]) and the manufactur- ing process (critical process parameters) beforehand is essential for successful tech transfer, ultimately defining the eventual success of the partnership between CDMOs and biotech companies. Initial technical conversations between the CDMO and the biotech client are crucial, with discussions outlining the management of DP time- lines to ensure batches are manufactured according to an optimal schedule, with consideration to quality, all regulatory expectations, and current guidance. CDMOs should evaluate any process needs at the onset of manufacturing to determine the require- ments for success. Highly specialized MSAT teams must work closely with DP operations and quality exper ts to optimize the manufacturing process, batch release, and reg ulator y f i ling. In tandem, the necessar y precautions should be added based on the client's requirements, such as shear sensi- tiv it y, light sensitiv it y, temperat ure sensitiv it y, bioburden f i lt rat ion, a nd ster i lizing f i lter t ra in requirements. With early planning and transparent communi- cation, CDMOs can identify and mitigate any poten- tial roadblocks that could occur throughout the tech transfer process. Cross-functional input internally and jointly with the client is essential in determining the most reproducible and repeatable formulation, filling, inspection, and packaging and labeling pro- cesses that are essential when applying all previous learnings to the commercialization of the product. T he ef f ic ienc y of tec h t ra n sfer a l so re l ies on CDMOs hav i ng comprehen sive st a nda rd operat- ing procedures (SOPs), which provide a structured framework with detailed guidelines outlining the specific processes and protocols. SOPs help ensure consistency, facilitate smooth knowledge transfer, and assure compliance with reg ulations through effective quality control. Timely batch release Commercial batches should be released within a de- fined period of 30 days after the production date. By having all the required elements in place upon final DP completion, CDMOs can prevent wasting time and ensure that batches are released immediately. Meet- ing this stringent time frame and preventing delays relies on efficient quality systems. Before batch re- lease, CDMOs should carry out the following: • Executed batch record release review: manufac- turing and quality teams start co-reviewing all Tech transfer is an integral part of drug development and manufacturing.