Major Expansion of non-GMP Kilo Lab Capabilities

To meet the growing needs of our emerging, virtual, and specialty pharma customers!

Prior to 1995, most companies did not have kilo labs.  The options for carrying out a synthesis were a conventional lab, a pilot plant or full scale manufacturing.  The rapid growth of drug discovery research and the corresponding need to provide kilograms of material with little notice led pharmaceutical companies and their contractors to seek ways to efficiently, safely and quickly scale up laboratory procedures.  These early kilo labs were often not much more than very large flasks placed in an ice bath with a similar work up vessel that contained a bottom valve.  A tremendous amount of innovation has taken place over the last ten years, leading to the modern kilo lab that is capable of easily carrying out any procedure that has been done in a conventional lab.   

PCI synthesis has recently completed a significant expansion of it’s kilo lab capabilities for non-GMP manufacturing at our Devens facility.  This lab, which began operations in January 2010, complements our recently renovated GMP suites in Newburyport, and operates on a similar scale.  Our expanded non-GMP kilo lab can be used to prepare materials for a large number of activities, including API’s for non-clinical use, Regulatory Starting Materials for GMP syntheses, and key building blocks on large scale to support medicinal chemistry programs.  We will also use this lab to carry out runs of modified processes to demonstrate new procedures on large scale prior to them being used in our cGMP suites or scaled up further in our manufacturing plant.

The key to a successful kilo lab operation is to have the right people using the right equipment in the right way.  At PCI Synthesis, our definition of the right people starts with talented and skilled organic chemists, and also includes a great workplace culture and experienced leadership.  Our high rate of growth is due to repeat business from satisfied customers, and these customers always point to their confidence in our staff as the reason for their loyalty. 

Having the right equipment is also important, and PCI Synthesis has committed to this as well.  In addition to its two new cavernous walk-in hoods and a collection of large glass reactors, PCI has also acquired a new 5-gallon high-pressure reactor (1500 psi), a 30-inch stainless steel Nutsche filter, large glass chromatography columns capable of holding 10 kilograms of silica gel and several 20-liter rotavaps.  We are truly ready for whatever is required for a quick and successful scale up of your process.