Services

  • Clinical and commercial manufacturing. An experienced Project Manager will coordinate every single step of the project.
  • Flexibility and efficiency combined with regulatory compliance.
  • Right first time. More than 10 years of experience within the European market among others.
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  • Specialized in small/medium scale or personalized aseptic processing and lyophilization manufacturing services of high value sterile drugs and complex substances and formulations.
  • Aseptic filling of vials and plastic bottles. Pharmaceutical lyophilization of immunological products, gene therapy products and biotechnology products.
  • EU GMP authorization for the manufacture of biological medicines (including investigational medicinal products): small volume liquids and lyophilized products.
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  • Testing of raw materials, packaging materials, bulk solutions, in-process controls, and finished products.
  • Full range of techniques, design and execution of stability studies and complete development, transfer, implementation, and validation of analytical methods.
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  • Authorization for the manufacturing of aseptically prepared lyophilizates and small volume liquids of biological products, including investigational medicinal products.
  • In-house Qualified Person (QP) service. The QP, responsible for confirming or certifying batches, has the ultimate responsibility to ensure the quality of medicines and the fulfilment with the requirements.
  • EU GMP certified by the national Health Authority (AEMPS).
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  • Our main goal is to be your one-stop shop supplier for everything related to aseptic fill and finish and/or lyophilization.
  • Cold chain distribution management to round off our full-service package.
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About us

BIOTECH CDMO As a first-class european biotechnological company in the field of pharmaceutical contract manufacturing of sterile medicinal products, we use our expertise in Pharmaceutical R&D, Aseptic Filling and Lyophilization of biologics (peptides and proteins, antibodies / mAB, RNA, adenovirus, etc.), and our extensive knowledge of international requirements, enabling your product to meet the most […]

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CDMO biotecnológica

If you’re interested in a career with a fast-growing, world-class CDMO, then you’re in the right place.

As our company continues to grow, we’re always on the look-out for professional, talented and ambitious people that can help take our business to the next level and service our clients’ needs.

Have a look to our current vacancies. If you don’t see any that fit your experience, we would still like to hear from you so please contact us for future opportunities.

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      Parque Tecnológico de Álava, C/ Hermanos Lumiere 5, 01510 Miñano Mayor (Álava) -España
      +34 945 29 81 98
      VAT NUMBER: ESB01581388
      Registered firm in Registro Mercantil de Álava, Tomo 1685, Libro 0, Folio 25, Hoja VI-19624
      Certificate of GMP Compliance of a Manufacturer – Certificate Number ES/112HVI/18
      Manufacturing Authorization number 6476E