API R&D

Research & Development

We have deep experience in helping our clients move forward from the discovery phase of product development to the scale up of New Chemical Entities for clinical supply.

API Manufacturing and cGMP Polymer Manufacturing

When it comes to early stages API development and the delivery of clinical supplies, our R&D team is always ready to take on the toughest challenges.

PCI is a fully integrated Active Pharmaceutical Ingredient (API) manufacturer and custom synthesis supplier. We’ll be with you every step of the way as you develop your final API or chemical product. We can provide you with expertise in process research, process development, analytical development, process validation, regulatory support, and FDA filing.

All of PCI’s process research, early stage development, and small scale non-GMP manufacturing take place at our Devens site.

Facility Highlights:

  • 10,000 sq. ft. facility with 6 laboratories that house 28 hoods.
  • 30 person staff, ¾ PhD’s
  • 5 Kilo Labs

Our team of over 30 R&D professionals (more than half are PhDs), all with deep experience in small molecule development.

Our capabilities include:

  • Process Research – Custom synthesis and synthetic route evaluation from g – kg for API’s or intermediates
  • Process Development – Custom synthesis from kg – metric tons.
  • cGMP manufacturing of pharmaceutical actives and intermediates for clinical trials.
  • 15 DMF’s filed; 8 commercial products
  • Scaled up over 150 processes

Our Devens site is also fully equipped with on-site analytical equipment including:

  • GC an GC Headspace Systems
  • HPLC Systems Equipped with UV-VIS, DAD, CAD and RID
  • Ion Chromatography
  • Gel Permeation Chromatrography
  • UV-VIS, FTIR
  • Karl Fischer/Moisture Balance
  • Titration & Wet Chemistry Analysis
  • GC-FID Systems
  • GCMS
  • LCMS
  • Access to: NMR, X-RD, DSC

Equipment:

  • Glassware from ml to 100 liter jacketed glass vessels
  • 20 and 50 liter rotovaps
  • Various filtration equipment
  • Temperature ranges -78 – 240°C
  • Thin film evaporation
  • Flash chromatography
  • Prep chromatography
  • Micronization
  • High pressure par reactors