Process development, validation and scale up

Reliable manufacturing processes are essential for all drug substances and drug products—ensuring that you achieve the very highest level of quality. In the race to the clinic, you need to establish a robust and cost-effective process quickly. Timing is critical, and there is no room for error. This sense of urgency continues as the drug moves through development. In addition to robustness, reliability, and cost effectiveness, superior quality and high yield are equally important, with the process forming an essential element of the FDA filing.

Large molecule expertise

Based on our unmatched experience with 1000+ molecules, including 50+ large molecule (biologics) drug substances, Thermo Fisher Scientific brings deep scientific expertise to every challenge. We apply our deep process development skills to significantly increase the batch yield and reduce processing time for your molecule. Our proven track record of scaling up biologics helps provide you with cost and time savings at every stage of development, with processes that ensure:

Upstream and downstream process development

Our comprehensive upstream and downstream process development capabilities and commitment to innovation, quality, and service make us the ideal partner for the process development of your mammalian cell culture projects. In early clinical phases, speed, flexibility, and expertise are critical to quickly establishing a robust, scalable process. Our experts have the experience and capabilities to develop an optimal process with long-term commercial manufacturing in sight, including:

Learn more about our experience developing small and large molecules, including non-mAb biologics in this article from BioPharm International.

Regulatory and cGMP guideline validation

During the later clinical phases, as part of the establishment of your commercial supply, we provide a complete validation package based on regulatory and cGMP guidelines. This package comprises:

You can be confident that you’ll have access to everything you need to ensure the reliability of your supply and consistent high quality. We have high-level expertise in integrated and efficient technology transfers—carrying out 119 in 2019 alone, with 44 for commercial projects, 60 for drug substances, and15 for development projects. Technology transfers, either for a scale-up or a move to another facility, are part of the normal course of business. This translates into a strategic and financial advantage for you. Even when the transfer is urgent, our team can execute it quickly and effectively to get your project back on track and preserve the supply of product. In all cases, we are driven by your deadlines, flexible in our approach and deter-mined to get it right the first time, every time.

Learn more about residual impurity analysis for continuous manufacturing in this article from BioPharm International.

Read our whitepaper to learn more about process characterization and validation for biologic processes.