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    Pharma Services Category of GBI

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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 (1)

    02 Antibody Drug Conjugate (1)

    03 BioAnalytical Services (2)

    04 Biologics, Bioprocess & Fermentation (2)

    05 GMP Manufacturing (1)

    06 Injectable / Parenteral (1)

    07 Separation & Purification (1)

    08 Stability Studies (1)

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    01 GBI (10)

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    01 U.S.A (10)

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    GBI

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      USP PROCESSING CELL CULTURE DEVELOPMENT

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      Services of a robust & reproducible cell culture USP process development for complex therapeutic protein drug candidates. Quality & regulatory requirements for safety, purity, potency, identity & immunogenicity through rigorous characterization are met.

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      Pharma Service: API Manufacturing

      Category: Biologics, Bioprocess & Fermentation

      Sub Category: Overview
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        cGMP CELL BANKING SERVICES

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        Short or long term storage for research or manufacturing available. Manufacturing offers research, master and working cell banks prepared using a controlled-rate freezing system and stored in cryogenic vapor-phase liquid nitrogen storage chambers.

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        Pharma Service: API Manufacturing

        Category: Biologics, Bioprocess & Fermentation

        Sub Category: Overview
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          DSP PURIFICATION DEVELOPMENT

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          Full downstream protein purification capabilities for cytokines, photo immune and vaccine conjugates, monoclonal antibodies, enzymes, complex biologics(antibody fusion proteins, Fc fusion proteins & bispecific antibodies), growth factors, exosomes, etc.

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          Pharma Service: API Manufacturing

          Category: Separation & Purification

          Sub Category: Extraction & Isolation
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            cGMP CLINICAL & COMMERCIAL MANUFACTURING

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            Multiple bioreactor platforms and scales for a variety of production modalities including batch, fed batch and perfusion. End to end manufacturing from creation of drug substance to drug product including mAbs, vaccines & ADCs.

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            Pharma Service: API Manufacturing

            Category: GMP Manufacturing

            Sub Category: Overview
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              BIOCONJUGATION

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              GBI has performed over 50 bioconjugation projects involving proof of concept, process development and validation scale-up cGMP manufacturing of multi--gram antibody drugs, theranostics and other protein bioconjugates.

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              Pharma Service: API Manufacturing

              Category: Antibody Drug Conjugate

              Sub Category: Overview
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                ASEPTIC FILL & FINISH

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                GBI provides customized, economical & compliant liquid filling of your products in cGMP conditions to support human clinical trials in the US, EU and Asia. Both Manual & Automated Aseptic filling validated for 400-2000 vials of 1-10mL volumes per vial.

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                Pharma Service: Drug Product Manufacturing

                Category: Injectable / Parenteral

                Sub Category: Clinical Supply
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                  STABILITY TESTING

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                  GBI offers stability studies of cGMP material per ICH guidelines. As part of GBI's services, product specific stability protocols and reports are generated for multiple storage conditions such as long-term (real-time) and accelerated conditions.

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                  Pharma Service: Analytical

                  Category: Stability Studies

                  Sub Category: Overview
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                    BIOANALYTICAL METHOD DEVELOPMENT

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                    GBI's protein characterization team provides bioanalytical method development services that follow current USP/EP guidance for a wide range of therapeutic products such as monoclonal antibodies, fusion proteins, antibody-drug conjugates, etc.

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                    Pharma Service: Analytical

                    Category: BioAnalytical Services

                    Sub Category: Method Development and Validation
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                      ASSAY VERIFICATION AND CHARACTERIZATION

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                      Assay verification is essential to measure levels of drug in human serum. Analytical methods ensure safety, purity, and efficacy of the drug candidates during the manufacturing process in order to enter clinicial trials.

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                      Pharma Service: Analytical

                      Category: BioAnalytical Services

                      Sub Category: Overview
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                        ADC DEVELOPMENT & COMMERCIALIZATION

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                        GBI supports the entire life cycle of Antibody Drug Conjugates (ADCs) from development to commercialization. It can develop and manufacture antibody drugs, theranostics, and other protein bioconjugates at cGMP-compliant scales for clinical applications.

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                        Pharma Service: API & Drug Product Development

                        Category: API Development

                        Sub Category: Antibody Drug Conjugate
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