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www.biopharminternational.com Manufacturing and Facilities eBook 2023 BioPharm International ® 13 Manufacturing: Tech Transfer and is safe for patients. Analytical method transfer is a crucial step in the overall process and must be done properly; it is tracked by QC/project manage- ment functions since these test methods are often the longer lead-time items in a project. Analytical expertise in analytical method transfer is a must- have as par t of a successf ul CDMO. The "hand- shake" between the analytical method transfer and quality control personnel requires people to be highly detail oriented, understand the product being manufactured, and be in close communi- cation throughout the organization and with the client when challenges arise in the process. • Quality assurance/control personnel author, re- view, and approve in-process specifications and finished product specifications cross-functionally with the client to demonstrate that the product meets safety, integrity, strength, purity, and qual- ity requirements. This then leads to the release of the product to the client where the product is used to meet patient needs either by being supplied to clinical trials or for commercial distribution. • M SAT re v iew a nd mon itor i ng: com merc i a l batches are reviewed by the MSAT team. CQAs will also be monitored to ensure the commer- cial production process remains in a validated state of control. The process and product mon- itoring reports present data on a quarterly or semi-annual basis across the industry. The tim- ing of these meetings is usually defined in the quality agreement, and any out-of-tolerance and out-of-specification data are evaluated as part of the continued-process-verification program. These data are communicated transparent ly to the client. Any changes in the manufactur- ing process are evaluated for the impact on the established process performance qualification. Regulatory filings are reviewed cross-function- ally with the client. Shortening timelines By offering the ability to manufacture the drug sub- stance (DS) and DP at a single site, CDMOs can further accelerate timelines to critical milestones. DS can be conditionally released, allowing the next steps of DP manufacturing to quickly commence. As a result, the overall batch release timeline can be reduced. By holding back a small proportion of the DS batch for quality control testing, which must be performed according to a specific quality agreement between CDMOs and their clients, the remainder can be pro- gressed and used to complete the fill/finish process. The conditional release enables f lexibility in bio- logic production, allowing DS batch release and DP manufacture to run in parallel, accelerating time- lines while ensuring a safe and high-quality product. Regulatory understanding All processes and procedures throughout biologic development and manufacturing must be compli- ant with stringent regulator y guidance to ensure the quality and safety of the medicine that will be i njec ted i nto pat ients. To g ua ra ntee reg u lator y compliance throughout biologic drug production, there must be a quality-driven infrastructure. This t y pe of infrastructure plays an important role in tech transfer, enabling the release of batches on time and preempting any qualit y issues, such as deviations from critical quality parameters (CQPs), CQAs, or SOPs. As a result, qualit y-driven infra- structures are critical to ensure the on-time deliv- ery of drug products. CDMOs must therefore adopt a strict quality man- agement system (QMS) that acts as a framework for quality, safety, and efficacy. The QMS will help to en- sure every raw material and component of the drug production and manufacturing process is well char- acterized and defined to meet all GMP regulations. As quality is built into the manufacturing process, having a robust QMS can ease the process of proving regulatory compliance, helping to streamline regu- latory approval and ultimately reducing timelines to market. Future demand for speed With a growing reliance on CDMOs to support the production of biologics, it will become increasingly important for biologics developers to select a partner that can meet all their projects' needs while stream- lining timelines. As a result, the need for effective tech transfer processes that are built with regulatory compliance in mind can be expected to continue to grow in the future. To prevent possible delays a nd prov ide ex pe- dited timelines to key regulatory milestones on the journey to market, CDMOs need to build manufac- turing processes with a focus on optimizing tech transfer processes that can ultimately translate into easy-to-understand manufacturing processes that meet regulatory compliance expectations. CDMOs that are mindful of meeting rigorous regulatory stan- dards adopt a thorough authoring and review system to build out regulatory sections based on the client's needs. When choosing a partner, biopharma compa- nies must also carefully assess whether the CDMO has the tech transfer and regulatory expertise needed for success. Reference 1. SkyeQuest Technology Group, Global Contract De- velopment and Manufacturing Organization (CDMO) Outsourcing Market. Market Research Report, sky- questt.com, December 2022. ■