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    Pharma Services Category of Biovian

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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 Analytical Testing Services (1)

    03 Biologic Drugs (2)

    04 Biologics, Bioprocess & Fermentation (1)

    05 Contract Manufacturing (3)

    06 Formulation Development (1)

    07 GMP Manufacturing (1)

    08 Injectable / Parenteral (1)

    09 Lyophilization (1)

    10 Process Safety Assessment (1)

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    01 Biovian (13)

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    Biovian

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      BIOTECH CDMO FOR MICROBIAL FERMENTATION

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      Biovian is a CDMO for the development & GMP manufacturing of biologics. Biovian offers cell line development, mammalian cultivation, microbial fermentation, protein purification, viral vector production, aseptic filling, labeling & QP release.

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      Pharma Service: API Manufacturing

      Category: Biologics, Bioprocess & Fermentation

      Sub Category: Overview
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        CDMO FOR MICROBIAL PRODUCTS

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        Biovian is a one-stop-shop CDMO for GMP manufacture and development of biopharmaceuticals. Biovian offers cell line development, mammalian cultivation, microbial fermentation, protein purification, viral vector production, formulation, aseptic filling, labeling and QP release.

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        Pharma Service: API Manufacturing

        Category: Contract Manufacturing

        Sub Category: Overview
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          CDMO FOR MAMMALIAN PRODUCTS

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          Biovian provides mammalian cell based production of API´s and Drug Substances. Biovian has separate mammalian GMP-manufacturing unit comprising state-of-the art bioreactor, harvesting equipment and several downstream suites and equipment which allows flexible production scenarios.

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          Pharma Service: API Manufacturing

          Category: Contract Manufacturing

          Sub Category: Overview
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            CDMO FOR VIRAL VECTOR PRODUCTS

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            Biovian has extensive experience and knowledge in Viral Vector Production for gene therapy applications. Biovian holds EMA license for producing Viral vector products for clinical trials as well as for commercial use.

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            Pharma Service: API Manufacturing

            Category: Contract Manufacturing

            Sub Category: Overview
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              MANUFACTURING OF BIOPHARMACEUTICALS

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              Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals covering services from early development to finished vial. Biovian's 2700 m2 facilities are EMA certified and FDA inspected for cGMP production of investigational and commercial products.

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              Pharma Service: API Manufacturing

              Category: GMP Manufacturing

              Sub Category: Overview
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                LYOPHILISATION OF MICROBIAL PRODUCTS

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                Biovian provides microbial and yeast based production of API´s and Drug Substances. Biovian has separate microbial GMP-manufacturing unit comprising state-of-the art fermenters, harvesting equipment and several downstream suites.

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                Pharma Service: API Manufacturing

                Category: Lyophilization

                Sub Category: Overview
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                  MICROBIOLOGICAL QC & SAFETY ASSAYS

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                  Biovian provides integrated analytical Quality Control services to support Drug Substances and Drug Product release. Biovian QC-laboratory complies with the Ph.Eur. and USP.

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                  Pharma Service: API Manufacturing

                  Category: Process Safety Assessment

                  Sub Category: Overview
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                    ASEPTIC FILLING CONTRACT SERVICES

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                    Biovian has expertise in very complex dosing requirements and aseptic filling processes. Biovan offers a range of contract services from fill and finish to labelling and QP-release of drug products for clinical trial purposes.

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                    Pharma Service: Drug Product Manufacturing

                    Category: Biologic Drugs

                    Sub Category: High Potent
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                      ASEPTIC FILL-FINISH OF DRUG PRODUCTS FOR CLINICAL TRIAL

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                      Biovian has expertise in very complex dosing requirements and aseptic processes. Biovan offers full service from fill and finish to labelling and QP-release of Drug Products for clinical trial purposes.

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                      Pharma Service: Drug Product Manufacturing

                      Category: Injectable / Parenteral

                      Sub Category: Clinical Supply
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                        LABORATORY BATCH SCALE TO PILOT & FULL PRODUCTION SCALE

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                        Biovian provides linear scale-up from laboratory to full GMP production scale aiming for high quality and cost efficiency.

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                        Pharma Service: API & Drug Product Development

                        Category: API Development

                        Sub Category: Scale-Up Capabilities
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                          TECH TRANSFER

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                          Biovian offers process development services with different starting points differing on client process and development requirements: full turn-key development or technology transfer based process adaptation to meet GMP requirements.

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                          Pharma Service: API & Drug Product Development

                          Category: Formulation Development

                          Sub Category: Tech Transfer
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                            ANALYTICAL METHODS FOR IN-PROCESS CONTROL

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                            Biovian provides an extensive set of analytical methods for in-process control and end product analysis.

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                            Pharma Service: Analytical

                            Category: Analytical Testing Services

                            Sub Category: Overview
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                              GMP-GRADE PLASMID DNA PRODUCTION

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                              Biovian offers premium plasmid DNA CDMO services for preclinical, clinical and commercial production. In its Plasmid DNA production, it adheres to the same GMP standards from the starting material to the final drug products.

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                              Pharma Service: Drug Product Manufacturing

                              Category: Biologic Drugs

                              Sub Category: DNA / RNA
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