A commitment to:
Quality. Consistency. Confidentiality.
Welcome to Ludger
The team of specialists at Ludger can provide glycoprofiling services and technology to help you engineer, optimise, measure and control the glycosylation of your therapeutic glycoprotein product. It can be used within a QbD framework for biopharmaceutical realisation. Established in 1999 we have a wealth of experience providing structural glycan characterisation of innovator and biosimilar biotherapeutics, including:
- Monoclonal antibodies (mAbs)
- Hormones e.g erythropoeitin (EPO)
- Fc fusion proteins
- Plant glycoproteins
- Viral glycoproteins
- Parasitic glycoproteins
- Clotting factors
This will help you address safety, efficacy, product consistency, stability and half-life, regulatory compliance, patent issues and comparability of your drugs. Analytical methods used in house include (U)HPLC, ESI-MS, MALDI-MS, LC-MS. In addition we can work to Good Manufacturing Practice (GMP) level services for our clients.
Quality and Reliability
Ludger operates a Quality Management System (QMS) which covers all aspects of the company's operations, including glycoprofiling contract analysis, and is based on the ISO 9001:2008 registration framework. Ludger is an ISO9001 Registered Company.
Glycoprofiling analyses follow the relevant ICH guidelines including ICH Q2(R1).
Glycoprofiling work for biopharmaceutical clients who require GMP level analyses is performed within GMP-compliant modules which implement the GMP protocol requirements for non-GMP external contractors as detailed by the sponsor. These typically include detailed evidence of the following being added to the analytical report: operators, equipment, raw materials, reagents, primary raw data, data and process reliability, archiving. We are also open to inspection from any of our Clients.