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Pharma Services Category of PCI Synthesis

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API Development

Analytical Method Development

Analytical Testing Services

Chiral Synthesis

Clinical Supply

Controlled Substance

Custom Synthesis & Manufacturing

Fine Chemical / Intermediate

GMP Manufacturing

Halogenation

High Temperature Reaction (> 200 °C)

Hydrogenation

Low Temperature / Cryogenic conditions

Micronization

Preformulation & Material Science

Process Development & Optimization

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PCI Synthesis

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UNITED STATES

Clinical Supply

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- Service Details

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.

- Directory Listing

Pharma Service: API Manufacturing

Category: Clinical Supply

Sub Category: Overview

Custom Synthesis from G to KG for API’s & I...

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Our capabilities include: Process Research – Custom synthesis and synthetic route evaluation from g – kg for API’s or intermediates.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

Process Development

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- Service Details

Our capabilities include: Process Development – Custom synthesis from kg – metric tons.

- Directory Listing

Pharma Service: API Manufacturing

Category: Process Development & Optimization

Sub Category: Overview

cGMP Manufacturing of Pharmaceutical Actives

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- Service Details

Our capabilities include: Process Development – cGMP manufacturing of pharmaceutical actives and intermediates for clinical trials.

- Directory Listing

Pharma Service: API Manufacturing

Category: GMP Manufacturing

Sub Category: Overview

cGMP Manufacturing of Intermediates

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- Service Details

Our capabilities include: Process Development – cGMP manufacturing of pharmaceutical actives and intermediates for clinical trials.

- Directory Listing

Pharma Service: API Manufacturing

Category: Fine Chemical / Intermediate

Sub Category: Overview

HPLC Systems Equipped with UV-VIS, DAD, CAD &...

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- Service Details

Our Devens site is also fully equipped with on-site analytical equipment including:HPLC Systems Equipped with UV-VIS, DAD, CAD and RID.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)

Equipment - Micronization

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- Service Details

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

- Directory Listing

Pharma Service: API Manufacturing

Category: Micronization

Sub Category: Overview

Small-Scale Fine Chemical Manufacturing

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- Service Details

Since 2003, PCI’s Devens Facility has been devoted exclusively to research and development, process development, as well as small-scale fine chemical manufacturing.

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Pharma Service: API Manufacturing

Category: Fine Chemical / Intermediate

Sub Category: Overview

Synthetic Route Evaluation

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- Service Details

PCI has an experienced, highly skilled team of process chemists and chemical engineers who are able to practice a wide range of reaction technologies at different scales.

- Directory Listing

Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

Hydrogenations

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- Service Details

PCI Synthesis Offers Reaction Technologies that Form the Basis for New Chemistry Innovations: Hydrogenations.

- Directory Listing

Pharma Service: API Manufacturing

Category: Hydrogenation

Sub Category: Overview

Chiral Synthesis

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- Service Details

PCI Synthesis Offers Reaction Technologies that Form the Basis for New Chemistry Innovations; Chiral Synthesis.

- Directory Listing

Pharma Service: API Manufacturing

Category: Chiral Synthesis

Sub Category: Overview

High Temperature Reactions

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- Service Details

PCI Synthesis Offers Reaction Technologies that Form the Basis for New Chemistry Innovations: High Temperature Reactions.

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Pharma Service: API Manufacturing

Category: High Temperature Reaction (> 200 °C)

Sub Category: Overview

Chlorination

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- Service Details

PCI Synthesis Offers Reaction Technologies that Form the Basis for New Chemistry Innovations: Chlorination.

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Pharma Service: API Manufacturing

Category: Halogenation

Sub Category: Overview

X-Ray Crystallography

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- Service Details

Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including: X-ray Crystallography.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

Nuclear Magnetic Resonance Spectroscopy

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- Service Details

Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including: Nuclear Magnetic Resonance Spectroscopy.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Solid state NMR

Differential Scanning Calorimetry

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- Service Details

Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including: Differential Scanning Calorimetry.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: DSC

Mass Spectroscopy

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- Service Details

Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including: Mass Spectroscopy.

Method Development & Validation

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- Service Details

Our analytical department is fully compliant with CFR Part II and all in process testing, method development, method qualification and method validation are done in house by our experienced team of analysts and analytical development scientists.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Scale-Up Capabilities

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- Service Details

That’s why we’ve built a seamless development solution that enables you to begin your active pharmaceutical ingredient development in our Devens R&D lab and then migrate it directly into our cGMP Newburyport API plant, where we offer up to 20,000 gallons of manufacturing capacity.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

Licensed DEA Controlled Substance API Manufac...

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- Service Details

As a fully integrated CMO, PCI is uniquely positioned to supply our customers with an entire suite of development, analytical and cGMP manufacturing services for DEA controlled substances.

- Directory Listing

Pharma Service: API Manufacturing

Category: Controlled Substance

Sub Category: Overview

Cryogenic API Manufacturing

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- Service Details

PCI Synthesis is equipped to run low temperature chemical reaction at research, development, pilot, and commercial scale (4,000 Liter). All of our equipment is ready to carry out reactions to as low as -80°C.

- Directory Listing

Pharma Service: API Manufacturing

Category: Low Temperature / Cryogenic conditions

Sub Category: Overview

cGMP Medical Grade Polymers

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- Service Details

PCI’s technical and manufacturing teams have executed countless cGMP Polymer related synthesis projects.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

Suspension Polymerization

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- Service Details

Size-controlled synthesis of poly(methacrylate) random copolymers beads then used as an enzyme-immobilizing substrate.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

Emulsion Polymerization

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- Service Details

Butyl Methacrylate emulsion polymerization that required extensive physical manipulation to achieve a narrow particle size distribution.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

Pharma Services Category of PCI Synthesis

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