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PCI

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Newburyport, Massachusetts, US

About PCI

What if you could find an R&D team that was unafraid of the most complex development challenges? What if you could find a partner that understood the importance of proactive project management? What if you could find a partner that could take you from discovery all the way through commercialization with one... Show more »

What if you could find an R&D team that was unafraid of the most complex development challenges? What if you could find a partner that understood the importance of proactive project management? What if you could find a partner that could take you from discovery all the way through commercialization with one organization?

Over the last decade, more than 100 companies have relied on North America’s leading API manufacturer to help them reach their development goals. We invite you to learn why.

PCI offers you everything you need from initial process research to commercial manufacturing.

We have more than 20 years of experience in chemical manufacturing, which has enabled us to develop deep expertise in custom NCEs, generic APIs, and custom manufactured fine chemicals. PCI combines the responsiveness of a small company with the capacity and capabilities of a much larger one. This unique combination enables us to:

  • Adapt and respond quickly and effectively to your development needs
  • Deliver products on-time and within agreed specifications
  • Offer competitive pricing and a true ease of doing business

Key Company Facts:

15 DMF’s (Drug Master File) filed:
• 7 Approved/pre-approved
• 8 Pending, 2 for submission in 2016
• Winner of 8 CMO Leadership Awards
• Scaled up 100’s of chemistry processes.
• 2009-2015, 96% of orders delivered on time
• 100+ employees
• Largest small molecule drug substance manufacturer in New England

Project Management
We believe in communication based on transparency and accountability, and make sure that any issues are brought up immediately. Our clients routinely tell us how much they value our proactive project management approach.

At PCI, we strive to keep our clients constantly informed about the progress of their projects, and provide them with regular weekly updates on every aspect of the work we are doing. We also make sure that any issues are brought up immediately, so that we can collaborate with our clients to solve the small problems before they grow into big ones.

PCI replaces the frequent communication complexities of dealing with overseas supplier-based solutions with the ready access of a domestic one. Our API manufacturing clients enjoy the ability to teleconference with us during regular business hours, and the ability to meet with us face-to-face on a regular basis. This closer collaboration enables PCI to speed API clients’ products to market in a manner that overseas outsourcing simply cannot.

PCI offers a turnkey solution for all the steps needed for any final API or drug substance manufacturing project, including process research, process development, analytical development, process validation, regulatory support, and FDA filing. PCI already has numerous API manufacturing products in its pipeline, including generics and new chemical entities (NCE’s) and will continue to launch and/or commercialize multiple API’s annually.

Our project management tactics include:

  • Kick-off Meetings (Internal and External)
  • Detailed Project Plans, Agreed Milestones and Deliverables
  • Weekly Tracking and Regular Reporting
  • Communications Based on Transparency and Accountability
  • Increased Flexibility and Responsiveness
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Our Services (23)


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Batch Release Testing

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Raw Material Testing

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Polymer Synthesis

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cGMP Polymers

PCI’s technical and manufacturing teams have executed countless cGMP Polymer related synthesis projects. The applications for the polymer projects we have engaged in have included medical devices (510k), drug delivery technologies, therapeutics, excipients, and medical grade coatings. All of these projects... Show more »

cGMP Polymers

PCI’s technical and manufacturing teams have executed countless cGMP Polymer related synthesis projects. The applications for the polymer projects we have engaged in have included medical devices (510k), drug delivery technologies, therapeutics, excipients, and medical grade coatings. All of these projects begin in our laboratories enabling our teams to not only improve many of our polymerization processes, but also to adopt the latest analytical techniques to support their development. PCI also has the capacity to produce all of our cGMP polymers in our Newburyport facility from kilo’s to tons.

Our recent polymer-related projects include:

  • Suspension Polymerization
  • Biodegradable Poly(ester) Copolymer
  • Post-Polymerization Modification of Polysaccharides
  • Anti-oxidant Poly(ester) Copolymer
  • Poly(acetal) Copolymer
  • Epoxy-type Oligomer
  • Hydroxybutyrate Polymer
  • Cross-linked Divinyl Benzene Co-Polymer
  • Methacrylate Co-Polymer
  • EVA Polymerization and Processing
  • Butadiene-Malaic Anhydride Co-Polymer
  • Carbohydrate based polymers
  • Emulsion Polymerization
  • Monomer Synthesis
  • Acrylate Co-Polymer
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Pharmaceutical Manufacturing

Price on request

Where we offer three class 100,000 cGMP Suites for Pre-Clinical and Clinical Manufacturing and 23 Reactors with a total of 20,000 Gallons of Manufacturing Capacity.

At PCI, we understand the enormous technical transfer headaches that you can encounter when you’re working to move your project from the lab to the plant.

That’s... Show more »

Where we offer three class 100,000 cGMP Suites for Pre-Clinical and Clinical Manufacturing and 23 Reactors with a total of 20,000 Gallons of Manufacturing Capacity.

At PCI, we understand the enormous technical transfer headaches that you can encounter when you’re working to move your project from the lab to the plant.

That’s why we’ve built a seamless development solution that enables you to begin your development in our Devens R&D lab and then migrate it directly into our Newburyport plant, where we offer up to 20,000 gallons of manufacturing capacity. Because of our closely aligned R&D and scale-up capabilities, you can feel confident in knowing that we’ll be with you all the way, from discovery to marketplace.

Reactors
GL-51
50 gallon glass lined reactor (Hot Oil)
GL-54
50 gallon glass lined reactor (high pressure)
IL-51
55 gallon stainless steel reactor (cryogenic)
GL-101
100 gallon glass lined reactor
GL-102
100 gallon glass lined reactor
GL-103
100 gallon glass lined reactor
GL-201
200 gallon glass lined reactor
GL-501
500 gallon glass lined reactor
GL-502
500 gallon glass lined reactor
GL-503
400 gallon glass lined receivers
GL-504
400 gallon glass lined receivers
SS-501
500 gallon stainless steel reactor
GL-1001
1000 gallon glass lined reactor
GL-1002
1000 gallon glass lined reactor
GL-1003
1000 gallon glass lined reactor
SS-1001
1000 gallon stainless steel reactor
HC-1001
1000 gallon hastelloy reactor
IN-1401
1400 gallon hastelloy reactor
GL-2001
2000 gallon glass lined reactor
GL-2002
2000 gallon glass lined reactor
GL-2003
2000 gallon glass lined reactor
GL-2004
2000 gallon glass lined reactor
Filter Dryers
GFN-1
.1 square meter pressure filter dryer
GFN-2
.25 square meter pressure filter dryer
PFN-1
1 square meter pressure filter dryer
PFN-2
2 square meter pressure filter dryer
PFN-3
.5 square meter pressure filter dryer
CFG
48″ stainless steel centrifuge
Driers
VSD-1/2/3/4
Vacuum shelf tray dryer
VSD-6
Vacuum shelf tray dryer
DCD
3 cubic meter glass lined rotary dryer
Milling/Particle Size Manipulation
Comil 1
Comil 2
Comil 3
Fitzmill
Micronizer
Sweco-01
Sweco-02

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Quality Assurance

Price on request

PCI’s FDA inspected facilities are fully compliant with ICHQ7 and CFR Part II.

PCI maintains a robust and comprehensive cGMP quality system. We have been audited by all of our customers, quality professionals (QP’s), and regulatory agencies. PCI’s Quality Assurance team insures the high quality manufacturing for all our... Show more »

PCI’s FDA inspected facilities are fully compliant with ICHQ7 and CFR Part II.

PCI maintains a robust and comprehensive cGMP quality system. We have been audited by all of our customers, quality professionals (QP’s), and regulatory agencies. PCI’s Quality Assurance team insures the high quality manufacturing for all our commercial API and clinical drug substance products.

Regulatory

  • Interaction with regulatory bodies (FDA and equivalents)
  • Every project is assigned an internal QA professional who works closely with the sponsor’s regulatory representative
  • Internally prepare all Drug Master Files (DMF’s)
  • Assist with all aspects of sponsor CMC filings
  • Continuous auditing of all critical raw material supplier

R&D Support

  • R&D Team that develops processes that meet ICH guidelines and USP specifications
  • DOE studies to fully understand critical process parameters
  • Production of qualified reference standards
  • Employ prep-chromatography to isolate impurities and evaluate for genotoxicity
  • Kilo labs for process validation and process confirmation

Facilities

  • Class 100,000 kilo suites for pre-clinical and clinical material (Phase I-II)
  • 20,000 gal of manufacturing capacity for late phase (Phase III) and commercial manufacturing
  • Class 100,000 finishing and packaging areas for final products
  • On-site cGMP laboratories fully staffed and equipped for raw material testing, in process testing, final release testing, method development and full stability testing
  • Capabilities to develop and manufacture API’s for injectables, opthalmics and controlled substances.

FDA Audits

  • Newburyport – April 2006, November 2008, May 2010, August 2011, December 2012, September 2013 and April 2015
  • Devens – October 2005; June 2008
  • Leominster – February 2002, November 2003, December 2004
  • Pre-Approval Inspection (PAI) – October 2002, October 2005 and April 2006, August 2011, Dec 2012, Sept 2013, April 2015
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Retrosynthetic Analysis and Synthetic Route Design

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Custom Manufacturing

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Cell Culture Scale-Up

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Process Consulting

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Chemical Synthesis

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PCI is perfectly positioned to address your cGMP manufacturing needs through all phases of clinical trials. We can help you move seamlessly from the lab to the plant, without the need for technology transfer to another company.

You can count on PCI for multi-step synthetic processing in volumes ranging from single kilo’s to... Show more »

PCI is perfectly positioned to address your cGMP manufacturing needs through all phases of clinical trials. We can help you move seamlessly from the lab to the plant, without the need for technology transfer to another company.

You can count on PCI for multi-step synthetic processing in volumes ranging from single kilo’s to metric tons.

You can also rely upon PCI’s deep regulatory experience to assist you through each phase of the clinical trial process.

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kilogram ton

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Project Management

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Cells and Tissues

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Materials Science

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Biology

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Chemistry and Materials

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Product Quality Control

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Synthetic Chemistry

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Product Development, Testing, and Packaging

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Analytical Chemistry Services

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Analytical Chemistry Services

Analytical Chemistry Services

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Material Testing Services

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Material Characterization Services

Material Characterization Services

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Formulation Services

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Manufacturing Services

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Mammalian Cell Culture

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