Clinical Supply Manufacturing

Experimental Products for Phase I & II Studies


BioKey has class 100000 modular GMP clean rooms for oral therapeutics and nutraceutical product manufacturing covering US, Canada, and Asian countries which manufacture, package, label, and release clinical supplies for liquid, solid, and semisolid dosage forms.

Clinical Supply Manufacturing Capabilities

  • BioKey’s GMP pilot plant has the capacity of supplying 5,000 to 50,000 tablets and capsules per day (depending on the tableting process).
  • BioKey can develop a formula and process for the experimental product for phase I&II studies.  We typically can make batches up to 25 Kg in our GMP pilot plant.  If a formula/process exists, we can transfer it to our facility and adapt it if required.
  • We work closely with our clients to establish raw material test methods, in-process test methods, and finish product test methods and their corresponding specifications.  We also work collaboratively with our clients while generating a Master Batch Record and a Master Packaging Record for the product.
  • We are able to package and label the bulk mater to conform to the need of the clinical trial protocol.
  • We have added manufacturing nutraceutical oral drinks in our facility using a 500L pasteurizer tank.

BioKey's facilities are cGMP certified.