CONSULTANT CONNECTION – TAKE IT TO THE CLINIC
Help your biotech clients save time and money on Phase I trials while maintaining cGMP quality. 
Learn more in this issue of Consultant Connection.
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Quality, Speed and Cost Savings for Your Phase I Drug Manufacture
What if you could bring your clients a fast and safe solution for cGMP manufacture of their Phase I drugs right at the clinical research unit (CRU) – instead of engaging a contract manufacturing organization (CMO)?  

This solution simplifies the drug development journey for small biopharma organizations looking to streamline and also offers: 
  • Quality and Safety – Phase I trials are all about safety. The real advantage of a cGMP pharmacy over a traditional compounding pharmacy is that cGMP includes a quality management system (QMS), not just pharmacist oversight. A Phase I CRU that offers an onsite cGMP pharmacy can meet these rigorous quality specifications and leverage process information related to Chemistry, Manufacturing and Control (CMC) that can be used in later trial stages and investigational new drug amendments. 
  • Save Time – A full run of cGMP product at a CMO can take significant time – about 9 to 12 months. However, a CRU cGMP pharmacy can supply a small Phase I run in 3 to 5 months, right on-site, while providing a QMS and data to meet regulatory requirements. The staff can administer doses right away, decreasing the need for stability testing. What’s more, sponsors gain flexibility and speed for “on-the-fly” adjustments in dosage and protocol designs, based on safety markers for adaptive trial design. 
  • Cost Efficiency – Late toxicology results or safety data can result in costly CMC reformulation and wasteful full product runs. Manufacturing small runs at a CRU reduces cost and waste of active pharmaceutical ingredient (API), while accommodating variability in formulation – all without expensive delays. 
Phase I cGMP benefits overview
Manufacturing is estimated to be 20-40% of the entire cost of developing of a drug.

cGMP at a CMO results in 200-300% excess API, whereas cGMP at a CRU results in only 1-25% excess API.
Contact Your Consultant Connectors
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Lecia Johnson
PHASE I DRUG MANUFACTURE FOR QUALITY, SPEED AND COST SAVINGS
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cGMP Resources
Past Consultant Connection Articles
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