API Manufacturing

TBD-Biodiscovery is a EU GMP-certified company. We supply high quality active pharmaceutical ingredients and advanced intermediates to pharmaceutical industry. What we do is a small scale contract manufacturing – batch sizes are in the range from grams to kilos.

The GMP compliance certificate was firstly issued in the end of 2008. The latest re-audit was carrried out by our Drug Agency in May 2016. The certificate has been prolonged and allows us to continue with the GMP-regulated production. At the moment TBD-Biodiscovery is a supplier of active pharmaceutical ingredients used in the anticancer therapy, influenza treatment, conjunctivitis treatment, PET research etc. TBD-Biodiscovery will support you during the early drug development and preparation of clinical batches for Phase 1/Phase 2, although we also do operate in commercial domain and work with generics, so if you need a contract manufacturer for niche products, then we can be a partner of choice.

TBD-Biodiscovery has two separate facilities for the production of non-cytotoxic active pharmaceutical ingredients and cytotoxics (HPAPIs), such as Bortezomib API, e.g.

 Our API portfolio includes the following products (non-confidential info):

If you are interested in getting more information on our products or you have an idea for API development, please do not hesitate to contact us!

TBD-BIODISCOVERY OFFERS:

  • Scale-up and GMP-certified manufacture of commercial and clinical API and HPAPI batches (investigational medicinal product), containing CMC/ASMF documentation, impurity synthesis and full analytical package.
  • Stability studies and tests for final dosage form.
  • Extensive experience in analytics: routine analysis, method development, method validation and client support during submission.
  • Wide range of experience in cytotoxics and anticancers.
  • Production of commercial batches of niche products or API for orphan drugs (up to 10 kg/batch and 400 kg per year).
  • Packaging in clean-room
  • Customer focused project management
  • Open communication with customers
  • Motivated and competent staff