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    Pharma Services Category of Cook Pharmica LLC.

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 API Development (2)

    02 Analytical Testing Services (4)

    03 Clinical Services (1)

    04 Clinical Supply (1)

    05 Contract Services (2)

    06 Design & Development (2)

    07 Formulation Development (4)

    08 GMP Manufacturing (1)

    09 Injectable / Parenteral (2)

    10 Lyophilization (1)

    11 Protein / Peptide (1)

    12 Scale Up (1)

    13 Separation & Purification (1)

    14 Stability Studies (1)

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    01 Cook Pharmica LLC. (24)

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    01 U.S.A (24)

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    Cook Pharmica LLC.

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    CUSTOM PEPTIDE SYNTHESIS SERVICES

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    Cook Pharmica is a CDMO for peptide APIs and peptide drugs that offers custom peptide synthesis services. Its peptide synthesis and manufacturing services include custom peptide synthesis and custom peptide manufacturing for cGMP peptides.

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    Pharma Service: API Manufacturing

    Category: Protein / Peptide

    Sub Category: Synthesis
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    COMMERCIAL cGMP PRODUCTION

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    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.

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    Pharma Service: API Manufacturing

    Category: GMP Manufacturing

    Sub Category: Overview
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    cGMP CLINICAL SUPPLIES PRODUCTION

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

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    Pharma Service: API Manufacturing

    Category: Clinical Supply

    Sub Category: Overview
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    LARGE SCALE BIOLOGICS MANUFACTURING

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    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.

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    Pharma Service: API Manufacturing

    Category: Scale Up

    Sub Category: Overview
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    CHROMATOGRAPHY & COLUMNS FROM 10 TO 80 CM

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    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.

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    Pharma Service: API Manufacturing

    Category: Separation & Purification

    Sub Category: Extraction & Isolation
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    VIAL FILLING & LYOPHILIZATION

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    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
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    PREFILLED SYRINGE FILLING

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    Cook Pharmica’s parenteral contract manufacturing facility includes a syringe filling line with an annual capacity of up to 70 million syringes. Fully enclosed in a barrier isolator, it offers the highest level of CGMP aseptic processing available.

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    Pharma Service: Drug Product Manufacturing

    Category: Injectable / Parenteral

    Sub Category: Pre-Filled Syringe
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    ANNUAL CAPACITY OF UPTO 70 MILLION UNITS

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    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.

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    Pharma Service: Drug Product Manufacturing

    Category: Injectable / Parenteral

    Sub Category: Overview
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    PROCESS DEVELOPMENT FOR cGMP PERFORMANCE

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    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.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    LYOPHILIZED PRODUCTS

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    The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. Lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Injectable / Parenteral
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    LYOPHILIZATION CYCLE OPTIMIZATION

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    Formulation scientists at Cook Pharmica have great experience in a variety of formulations & product presentations. For products that need lyophilization, the required lyophilization cycles can be optimized by using a LyoStar II™ development lyophilizer.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Lyophilization
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    OPTIMIZE CLINICAL DRUG PRODUCTS

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

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Clinical Supply
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    MEDIA & FEED SCREENING & OPTIMIZATION

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    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.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    LIQUID FORMULATION DEVELOPMENT

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    The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. Lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Sterile Liquid Formulation
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    KARL FISCHER TITRATION FOR LIQUID FORMULATION

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    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
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    PRODUCT CHARACTERIZATION USING HPLC/UHPLC DETECTION

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    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: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    PRODUCT CHARACTERIZATION BY UV/DAD/FLD/CAD/PAD DETECTIO...

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    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: UV Spectrophotometry
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    CAPILLARY ELECTROPHORESIS/ISOELECTRIC FOCUSING

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    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: Isoelectric Focusing
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    STABILITY STUDIES OF LIQUID OR LYOPHILIZED FORMULATION

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    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.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    CLINICAL SECONDARY PACKAGING

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    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.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    PREFILLED SYRINGE FILLING

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    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.

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    Pharma Service: Packaging

    Category: Contract Services

    Sub Category: Pre-Filled Syringe
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    BLISTER PACK OF FINAL PREFILLED SYRINGE PRODUCT

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

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    Pharma Service: Packaging

    Category: Contract Services

    Sub Category: Blister
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    LABEL DESIGN FOR MARKETED OR CLINICAL PRODUCT

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    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.

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    Pharma Service: Packaging

    Category: Design & Development

    Sub Category: Label
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    COMMERCIAL SECONDARY PACKAGING

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    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.

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    Pharma Service: Packaging

    Category: Design & Development

    Sub Category: Secondary Packaging
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