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Pharma Services Category of Cook Pharmica LLC.

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API Development

Analytical Testing Services

Clinical Services

Clinical Supply

Contract Services

Design & Development

Formulation Development

GMP Manufacturing

Injectable / Parenteral

Lyophilization

Protein / Peptide

Scale Up

Separation & Purification

Stability Studies

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Cook Pharmica LLC.

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UNITED STATES

CDMO of Recombinant Proteins

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- Service Details

Cook Pharmacia's biologics manufacturing group at Cook Pharmica has highly experienced staff who work closely with the development group to ensure scalability to full CGMP production.

- Directory Listing

Pharma Service: API Manufacturing

Category: Protein / Peptide

Sub Category: Synthesis

Commercial cGMP Production

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- Service Details

Cook Pharmica is a leading contract development and manufacturing organization (CDMO) centrally located in Bloomington, Indiana. From the beginning, Cook Pharmica set out to build a CDMO that would meet and exceed the expectations of the biopharmaceutical industry.

- Directory Listing

Pharma Service: API Manufacturing

Category: GMP Manufacturing

Sub Category: Overview

Clinical cGMP Production

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- Service Details

Cook Pharmica is a leading contract development and manufacturing organization (CDMO) centrally located in Bloomington, Indiana. From the beginning, Cook Pharmica set out to build a CDMO that would meet and exceed the expectations of the biopharmaceutical industry.

- Directory Listing

Pharma Service: API Manufacturing

Category: Clinical Supply

Sub Category: Overview

Large Scale Biologics Manufacturing

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- Service Details

Cook Pharmica's unique model supports everything from process development to large-scale biologics manufacturing, from analytical program design to formulation development (liquid or lyophilized), and from aseptic filling in vials or syringes to final packaged goods.

- Directory Listing

Pharma Service: API Manufacturing

Category: Scale Up

Sub Category: Overview

Chromatography & Columns from 10 to 80 cm

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- Service Details

Cook Pharmica’s highly experienced purification group can purify any type of protein and prepare the drug substance for either bulk formulation or formulation and aseptic filling into vials or syringes.

- Directory Listing

Pharma Service: API Manufacturing

Category: Separation & Purification

Sub Category: Extraction & Isolation

Vial Filling & Lyophilization

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- Service Details

Cook Pharmica has an annual capacity of up to 15 million units and is fully enclosed in a barrier isolator, ensuring an aseptic filling environment. For products that require lyophilization, there is a 250 sq ft lyophilizer integrated into the vial line within the barrier isolator.

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Pharma Service: API Manufacturing

Category: Lyophilization

Sub Category: Overview

Prefilled Syringe Filling

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- Service Details

Cook Pharmica’s parenteral manufacturing area includes a high-speed syringe filling line that can meet an annual capacity of up to 70 million syringes. Fully enclosed in a barrier isolator, the syringe line offers the highest level of CGMP aseptic processing available.

- Directory Listing

Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Pre-Filled Syringe

Annual Capacity of upto 70 Million Units

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- Service Details

The parenteral manufacturing facility at Cook Pharmica can formulate, fill and package your product into a final vial or prefilled syringe presentation, making it ready to use for the patient or administrator.

- Directory Listing

Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Overview

Develop Processes that Ensure cGMP Performanc...

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- Service Details

From cell culture through recovery and purification, the process scientists at Cook Pharmica develop processes that ensure consistent CGMP manufacturing performance and a reliable product supply.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Fill Finish Process Development

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- Service Details

The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. For products that need the added stability of lyophilization, the required lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Injectable / Parenteral

Lyophilization Cycle Development & Optimizati...

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- Service Details

The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. For products that need the added stability of lyophilization, the required lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Lyophilization

Optimize Clinical Drug Products

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- Service Details

The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. For products that need the added stability of lyophilization, the required lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Clinical Supply

Media & Feed Screening & Optimization

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- Service Details

From cell culture through recovery and purification, the process scientists at Cook Pharmica develop processes that ensure consistent CGMP manufacturing performance and a reliable product supply.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Liquid Formulation Development

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- Service Details

The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. For products that need the added stability of lyophilization, the required lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Sterile Liquid Formulation

Karl Fischer Titration for Liquid Formulation

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- Service Details

Cook Pharmacia's On-site analytical laboratories are equipped with the latest in analytical instrumentation, enabling scientists to employ a full array of methodologies to characterize your product and develop assays that will manage your product’s integrity throughout its life cycle.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Karl Fischer / Water Analysis

Product Characterization Using HPLC/UHPLC Det...

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- Service Details

Cook Pharmacia's On-site analytical laboratories are equipped with the latest in analytical instrumentation, enabling scientists to employ a full array of methodologies to characterize your product and develop assays that will manage your product’s integrity throughout its life cycle.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

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

Product Characterization by UV/DAD/FLD/CAD/PA...

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- Service Details

Cook Pharmacia's On-site analytical laboratories are equipped with the latest in analytical instrumentation, enabling scientists to employ a full array of methodologies to characterize your product and develop assays that will manage your product’s integrity throughout its life cycle.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: UV Spectrophotometry

Capillary Electrophoresis/Isoelectric Focusin...

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- Service Details

Cook Pharmacia's On-site analytical laboratories are equipped with the latest in analytical instrumentation, enabling scientists to employ a full array of methodologies to characterize your product and develop assays that will manage your product’s integrity throughout its life cycle.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Isoelectric Focusing

Stability Studies of Liquid or Lyophilized Fo...

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- Service Details

Cook Pharmica product development organization develops processes, methods and formulations that support and improve the manufacturability and stability of our clients’ products. From early cell culture scientists to analytical specialists.

- Directory Listing

Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Clinical Secondary Packaging

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- Service Details

Cook Pharmica’s secondary packaging area can blister pack and/or carton the final product and prepare the prefilled syringe product for clinical or commercial distribution.

- Directory Listing

Pharma Service: Packaging

Category: Clinical Services

Sub Category: Secondary Packaging

Prefilled Syringe Filling

Contact the Supplier

- Service Details

Cook Pharmica’s parenteral manufacturing area includes a high-speed syringe filling line that can meet an annual capacity of up to 70 mil syringes. Fully enclosed in a barrier isolator, the syringe line offers the highest level of CGMP aseptic processing.

- Directory Listing

Pharma Service: Packaging

Category: Contract Services

Sub Category: Pre-Filled Syringe

Blister Pack of Final Prefilled Syringe Produ...

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- Service Details

The secondary packaging area can blister pack and/or carton the final product and prepare the prefilled syringe product for clinical or commercial distribution.

- Directory Listing

Pharma Service: Packaging

Category: Contract Services

Sub Category: Blister

Label Design for Marketed or Clinical Product

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- Service Details

Cook Pharmica offers real-time, automated inspection, labeling and bulk packaging, integrated with the filling suites via product pass-throughs. A full-service group is on site that can assist with label design for your marketed or clinical product.

- Directory Listing

Pharma Service: Packaging

Category: Design & Development

Sub Category: Label

Commercial Secondary Packaging

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- Service Details

Cook Pharmica’s secondary packaging area can blister pack and/or carton the final product and prepare the prefilled syringe product for clinical or commercial distribution.

- Directory Listing

Pharma Service: Packaging

Category: Design & Development

Sub Category: Secondary Packaging

Pharma Services Category of Cook Pharmica LLC.

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