Services
FORMULATION AND MANUFACTURE 
ASEPTIC FILL FINISH AND LYOPHILIZATION 
QUALITY CONTROL 
QUALITY ASSURANCE AND REGULATION 
DISTRIBUTION
- 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.
- 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.
- 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.
- 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).
- 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.
About us
BIOTECH CDMO As a first-class European biotech CDMO partner in the field of pharmaceutical contract manufacturing of sterile drugs, specialised in fill and finish services of multiple formats of vials for injection and plastic bottles (eye drop type), we use our expertise in Pharmaceutical R&D, Aseptic Filling, Lyophilization of Biologics (including peptides and proteins, antibodies […]
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.
Get in Touch
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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