Small-scale models (SSMs) are critical to biopharmaceutical process development, technology transfer, process characterization, and process validation. Demonstrating that an SSM represents the large-scale manufacturing system is also required by regulatory authorities. However, while many biopharmaceutical companies are trying to implement qualified SSMs, there are many hurdles to overcome when designing, executing, and analyzing...
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May 2021 | Development Group
Small-scale models (SSMs) are widely used in the biopharmaceutical industry. These models are used for process development and optimization, scale-up, technology transfer, process characterization, process validation, virus clearance studies, and resolution of deviations encountered during manufacturing throughout a product’s lifecycle. SSMs are also referred to as ‘scale-down models’ or ‘scaled-down models’. Demonstration that an SSM is representative of the large-scale manufacturing system is called ‘small-scale model qualification’ (SSMQ), which is sometimes also referred to as ‘assessment’, ‘evaluation’, or ‘verification’. The demonstration is an important task that supports process validation and is required by regulatory authorities. However, design, execution and analysis of SSMQ studies can be challenging due to the lack of clear guidance on current best practices. This white paper provides options and tools for design, execution, and data analysis of SSMQs together with illustrative case studies.
A best practice guide that highlights the challenge associated with variability in media solution and supports a proactive approach to the evaluation and self-audit of internal processes in medium solution preparation.
The purpose of this best practice guide is to provide key information and best practices for media supplier partners and companies in the biopharmaceutical industry on the design, development and controls for manufacturing of media and medium solutions to minimize potential variation that may impact product quality, process performance and operational efficiency and costs. It is intended that it can be used to support a proactive approach to evaluation and self-audit of internal processes.
CGT considerations when assigning responsibilities during a product transfer between a sponsor and a contract development manufacturing organization
Apr 2021 | Cell & Gene Therapy
With over 1000 CGT developers worldwide, the FDA expects to approve 10-20 CGT products per year annually from the year 2025. Based on this information, there is an industry emphasis on streamlining the technology transfer process for new products into CDMOs. There are many considerations that are unique to CGT and if discussed early in the NPI process, could help reduce the risk of unplanned disruptions and align expectations in the early stages. This paper presents a common understanding and proposed ownership of these unique aspects, developed via a consensus of CGT sponsor (client) and CDMO participants in the Validation workstream of BioPhorum Cell and Gene Therapy. These recommendations could serve well as pre-established expectations or as an agenda for an NPI–kickoff meeting upon the initiation of a CGT sponsor CDMO relationship.They could also be used to support master supply agreement and quality agreement discussions.
Technology transfer (TT): Strategies for maximizing successful drug substance TT using engineering, shake-down, and wet test runs
The technology transfer of biological products is a complex process requiring control of multiple unit operations and parameters to ensure product quality and process performance. To achieve product commercialization, the technology transfer sending unit must successfully transfer knowledge about both the product and the process to the receiving unit. A key strategy for maximizing successful scale-up and transfer efforts is the effective use of engineering and shake-down runs to confirm operational performance and product quality prior to embarking on good manufacturing practice runs such as process performance qualification runs. We consider key factors to consider in making the decision to perform shake-down or engineering runs. We also present industry benchmarking results of how engineering runs are used in drug substance technology transfers alongside the main themes and best practices that have emerged. Our goal is to provide companies with a framework for ensuring the “right first time” technology transfers with effective deployment of resources within increasingly aggressive timeline constraints
Technology transfer is a key foundational component in product commercialization. It is more than just the transfer of documents; it relates to all aspects of the transfer of knowledge and experience to the commercial manufacturing unit to ensure consistent, safe, and high-quality product. This is the first in a series of articles from the BioPhorum member companies discussing best practices and benchmarking of biopharmaceutical technology transfer. In this article, we provide the common terminology developed by BioPhorum to accommodate both transferring and receiving organizations. We also review the key elements of a robust technology transfer business process, including critical milestones. Finally, we provide a brief overview of the articles in this series.