Services

At medac CDMO, we offer reliable and adaptable solutions across all stages of the product lifecycle. Our processes and project structures are tailored to meet individual requirements – efficiently and with precision. With more than 25 years of experience in isolator-based sterile manufacturing, we provide advanced aseptic Fill & Finish services that meet the highest quality standards.
Services

Our services in a nutshell

Services

Commercial solutions

We provide aseptic Fill & Finish services for global markets from our two EU-based facilities. Drawing on long-standing expertise in commercial manufacturing, we ensure the reliable supply of sterile products worldwide.
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Commercial solutions

Services

Clinical solutions

With more than seven years of experience in clinical supply for small molecules and biomolecules – including antibody-drug conjugates (ADCs) – we support both biotech companies and pharmaceutical firms in the development of new therapies.
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Clinical solutions

Services

Development

Formulation development, lyophilization cycle design and related studies are conducted by qualified external partners with proven experience in the transfer of process parameters to production scale.
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Development

Services

Technology transfer

Efficient technology transfer is essential for a successful transition from development to commercial manufacturing. Our structured approach is based on collaboration, clear responsibilities and transparent communication.
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Technology transfer

Services

Global regulatory support

We provide regulatory services for human medicinal products across all lifecycle stages and international markets.
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Global regulatory support

Services

Analytical capabilities & stability

We support both clinical and commercial manufacturing with in-house analytical and microbiological services as well as stability studies.
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Analytical capabilities & stability

Services

Packaging & Storage

We provide in-house primary packaging solutions that are fully integrated into our GMP-compliant manufacturing processes. These include sterile handling and full batch traceability.
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Packaging & Storage