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Fast Trak Biomanufacturing Services

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Preclinical and clinical biologics CDMO services up to phase II. Fast Trak offers products and services in one place so you can avoid the pitfalls of working with multiple suppliers; inefficient processes, delayed batches, lack of product and process expertise. Whether you`re looking to manufacture toxicology batches or cGMP material for clinical trials, we can help you expedite molecules to clinic with full transparency. Beyond that, you will have the tools and know-how you need to take your process forward independently.

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Collaborate to get drugs through clinical trials

  • Regulatory know-how: batch documentation packages and IND enabling batches (CFDA)
  • Process expertise: single-use bioprocessing, process development: upstream/downstream
  • Process security: protection of IP black box approach, isolation and control of cell lines with security oversight (China)
  • Manufacturing capacity: toxicology batches, preclinical and clinical manufacturing
Convert processes to single-use technologies
  • Converting to single-use technology has the potential to cut your time to market, improve yields, and reduce water usage for improved process sustainability.
  • Whether you are switching to single-use or seeking a manufacturing service provider with expertise in this area, we can help.
Parallel processing, doubling operations for speeding molecules to clinic

Our Fast Trak biomanufacturing services teams support your process development, tech transfer, and manufacturing efforts in several ways to ensure your success.

  • Quality assurance guidance and project oversight
  • Persons-in-plant – your staff trains with our scientists
  • Batch records, material specifications, bills of materials, and reports – all provided to you