Process Excellence for Successful Biopharmaceuticals

Process & Analytical Development

Process & Analytical Development, Scale-up and Technology Transfer Services

Our extensive process development experience will ensure that your process technology is translated into a robust, scalable, economic and validatable manufacturing process quickly. Whether for clinical or commercial production, we can help your organization:

  • Plan bench-top process development for recombinant proteins, monoclonal antibodies and vaccines produced in bacterial fermentations, mammalian cell culture or eggs
  • Select the appropriate viral vector (AAV, adenovirus, lentivirus) production platform and contract development and manufacturing organization for your cell or gene therapy product
  • Incorporate scalable unit operations into your process
  • Scale-up the production process to produce clinical supplies
  • Ensure your process meets all relevant regulatory requirements
  • Select, develop, qualify and validate analytical methods for process development, product characterization, in-process testing, bulk drug substance release, final drug product release and stability studies
  • Develop formulations and delivery systems; specify appropriate container closure systems
  • Coordinate technology transfer of a scaled-up cGMP manufacturing process
  • Develop and deliver on a defined project timeline
  • Establish and implement strategies for process changes throughout the product lifecycle, including preparing comparability protocols and reports as well as the required regulatory submissions