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 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 […]
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.