PCI Expands Kilo Lab Capabilities

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.

Posted: April 8, 2013

API Manufacturing and Pharmaceutical 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 recently completed a significant expansion of its kilo lab capabilities for non-GMP manufacturing at its Devens facility.   The non-GMP kilo lab can be used to prepare materials for a large number of activities, including APIs for non-clinical use, Regulatory Starting Materials for GMP synthesis, and key building blocks on large scale to support medicinal chemistry programs.  The lab also carries out runs of modified processes to demonstrate new procedures on large scale prior to them being used in the cGMP suites or scaled up further in the manufacturing plant.

As part of the expansion PCI recently acquired several additional jacketed reactors and large capacity heater/chillers thus increasing its scale-up capabilities in the kilolab. With the newly acquired reactors, the kilolab is now equipped with several  jacketed reactors with volumes of 5L, 30L, 50L, and 100L.  Having these reactors helps the kilolab obtain scale-up information in the R&D development phase. This often minimizes unpleasant surprises when the process is tested in the pilot plant for the first time and provides the ability to produce relatively small amounts (1 – 20Kg) of non-GMP compounds to address customers’ needs in a timely manner.

Main advantages of the jacketed reactors vs traditional round-bottomed flasks:

  • Mixing characteristics resemble those of a standard plant reactor – one of the most common problems to address during scale-up
  • Heat-up and cool-down rates are similar to production vessels
  • The Jacketed reactor is equipped with a manual bottom valve allowing us to spot any discharge problems early
  • Solvent removal directly from the reactor mimics our production equipment much more closely as compared to a conventional rotary evaporator
  • Phase separations can easily become a bottleneck in the plant. Jacketed reactors provide invaluable information in this regard
  • Crystallization development – ability to mimic plant conditions during just this one operation can help us tremendously to save time and ensure that the desired polymorph of the API is obtained

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About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.