Clinical Batch Supply: Phase I, II, & III

In the race to get your molecule into the clinic, and, ultimately, approved, you need rapid process development of investigational product in an appropriate formulation and at sufficient quantity for trials – all with an eye to future commercial production and efficient transfer to cGMP production.

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.

Early Stage Clinical Supply

Early-stage clinical supply of biologic drug substance is produced at state-of- the-art cGMP facilities in Europe, North America, and Asia. A team of experts will surround your discovery with a full range of technologies and analytical services to not only run the project with the highest flexibility, but also deliver on time with exceptional yields and superior quality. In late-stage trials and beyond, your drug substance will also be manufactured at a cGMP commercial production facility where our team will deliver your batches right the first time and on time.

For large molecules (biologics), once preclinical development is complete, our award-winning tech transfer team will move your project to a cGMP facility for scale-up and production. This approach pays off in two ways. First, using a non-GMP lab for initial development activities accelerates your path to market. Second, the protocols of transferring into cGMP serve to identify opportunities to improve your process. We then develop stable and repeatable processes ready for validation by the FDA. We also identify areas of risk within the biomanufacturing process and take steps to mitigate these. We have particular expertise in cold chain, including storage of large molecules by refrigeration and freezing.

Clinical Development & Manufacturing Sites

Features of our biologics development & manufacturing facilities include:

  • Single-use cGMP bioreactors: 500 L, 1000 L, and 2000 L
  • Multiple single-use platforms supported
  • Fed-batch, perfusion, and XD® cell culture technology
  • Extensive technology transfer experience
  • Australian R&D tax credit of up to 43.5%
  • cGMP batch sizes from 10 grams to 10 kilograms of drug substance
  • Flexible biomanufacturing solutions

Download our Biologics Fact Sheet to learn more.