Process Development, Validation & Scale Up

Robust and 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, reliable, and cost-effective manufacturing process quickly. There is no time to lose, and you have to get it right. This sense of urgency continues as the drug moves through development. High quality, high yield, robustness, reliability, and cost effectiveness all become equally high priorities, 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 help give you cost and time savings at every stage of biologics development, with processes that yield:

  • Robust repeatability
  • Reliability
  • High quality and low cost

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:

  • Cell line development
  • Broad mammalian cell culture experience: mAbs, fusion proteins, bi-specifics, enzymes, fragments, and other recombinant proteins
  • Fed-batch, perfusion, and XD® cell culture processes
  • Design of Experiment (DoE) studies
  • Sartorius ambr® 15 and 250 microbioreactor systems
  • Glass and single-use bioreactors (3 L to 250 L)
  • Media/feed strategy optimization
  • Resin screening
  • Tecan Freedom EVO® platform with Repligen RoboColumn® system
  • UF/DF development
  • Virus clearance studies
  • Process and product characterization

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

 

Regulatory & 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:

  • Process validation with integrated control strategy
  • Validation of analytical assays
  • Virus validation of the downstream process
  • Impurity clearance
  • Resin re-use
  • In-process hold time studies
  • ICH stability studies
  • Container shipment studies
  • Release testing
  • CMC documentation in CTD format

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 particular expertise in integrated and efficient technology transfers – carrying out 185 in 2017 alone, with 138 for commercial projects, 44 for drug substances, and three 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.

Download our Biologics Fact Sheet.