GMP compliant protein analysis

The increase in successful protein therapeutic introductions is driving demand for protein analysis during clinical phases and release of production batches. Protagen AG recognized this early on and has been certified as a GMP-compliant (EU guidelines for Good Manufacturing Practice) protein analysis laboratory for several years.

Customer benefits from our protein analysis:

• high quality standards,
• excellent technical knowledge and
• long-standing experience

Protagen AG  has already successfully  introduced technology to the regulatory authorities and received excellent feedback for its quality system from frequent audits by its renowned customers.

Experience in detailed protein analyses:

Protagen is highly experienced in the detailed protein characterization of antibodies as well as analysis of other protein therapeutics such as

• EPO,
• Filgastrim,
• G-CSF,
• Insulin or
• Hirudin and others

in accordance with the ICH Q6B requirements.

Analytical strategies

Protagen offers a broad spectrum of qualified analytical equipment and validated methods from which Protagen develops optimal analytical strategies based on customer needs. On top of this, Protagen is able to develop and validate customer specific methods. The GMP certificate confirms that the protein analysis is in accordance with the requirements of the EU guidelines for Good Manufacturing Practice for drugs.

Please This e-mail address is being protected from spambots. You need JavaScript enabled to view it Protagen to design a project tailored to your needs.

Further information:

• GMP Brochure