Kinex Pharmaceuticals, Inc.

cGMP Development


  • Provided foundation for Phase I Clinical Trial
  • Phase I Clinical Trial conducted at two renowned test sites
  • $150,000 reduction in product cost for Phase I Clinical Trial cost
  • Additional employee hired
  • Drug product produced "on-demand" eliminating need for large inventory


Kinex Pharmaceuticals, LLC, located in Buffalo NY's BioMedical Corridor, was founded in 2003 as an R&D drug discovery company that develops next generation drugs, particularly anti-cancer. Typically, the company will develop the technology to the point of commercialization. At this point the technology may be out-licensed or sold to one of several major, proprietary customers, all of whom are major pharmaceutical companies. The senior management of Kinex Pharmaceuticals has developed numerous well known consumer drugs while working in the pharmaceutical industry.

In July, 2007 the company received FDA allowance to perform Phase I clinical trials for their first anti-cancer drug, KX2-391. This drug is a kinase inhibitor that had demonstrated efficacy in pre-clinical animal models of colon, pancreatic and prostrate cancers. Over a one year period the Phase I clinical trials will test the drug in terms of safety, tolerability and pharmacokinetics for about 50 patients with advanced malignancies.


Although this was viewed as a positive breakthrough for Kinex Pharmaceuticals, there were also concerns that needed to be addressed. The cost, distance and time to develop the drug product were considered to be very significant. This was particularly true if the production of the product was to be outsourced.

The company's management staff opted to produce the drug product in house, which was believed to be a preferable option to outsourcing. However, to do so, it would be necessary for Kinex Pharmaceuticals to become cGMP compliant. The company had limited resources and expertise in-house to address this issue in an expeditious manner. For this reason Insyte Consulting was contracted to help drive the cGMP initiative to support the packaging and distribution of the Phase I product.


A joint team of Insyte Consulting and the Kinex Pharmaceutical management staff was formed for the purpose of systematically achieving cGMP compliance. The first step was to evaluate the laboratory systems and procedures that were already in place. Where deficiencies were identified, improvements were introduced and documented in written form. As the system was formalized, training was provided in the proper use of the cGMP compliant program. Upon completion of training, a mock production run was conducted in order to validate the integrity of the systems and procedures, as well as identify any possible omissions to the program. Finally, test products were developed with the final documentation in place. This also included an evaluation of the people, processes and equipment prior to the actual production run. Based on this exercise minor modifications were made and some necessary problem solving activities were completed.

Kinex Pharmaceuticals realized several very significant benefits as results of cGMP. It provided the foundation for the actual Phase I clinical trial and enabled the company to have the trial conducted at two well-renowned test sites, Roswell Park Cancer Institute in Buffalo and M. D. Anderson Cancer Center in Houston. The cost of the Phase I trial program was reduced by approximately $150,000 by producing the drug product internally. This enabled the company to hire an additional employee to further accelerate its work. This approach provided Kinex with the flexibility to make product "on-demand" so they don't need to keep a large inventory. This was very important at the beginning when they didn't know how stable the material was. Additional costs were avoided due to reduced travel, shipping and other related expenses.

"Insyte Consulting effectively facilitated the process of setting up a cGMP compliant operation and provided the expertise that we did not have internally. As a result we were able to set up an in-house process that saved us more than $150,000 and were able to add an additional employee." - Dr Lyn Dyster, Vice President