Types of molecules
Understanding the molecular composition and behavior of your product is essential during the development of your API (Active Pharmaceutical Ingredient). Applying a suitable set of methods is a central SYMBIOSIS strength, taken from our core competencies of Process, Communication and Quality. This helps deliver the right results for your requirements.
Analyzing the complex structure of Biologics is our day-to-day business. Our experience extends across recombinant proteins, antibodies, virus-like particles (VLPs) and vaccines. Our understanding of the different characteristics of these biologics translates into a comprehensive set of methods that we apply to your product. Whether a specific analytic method such as N-terminal protein sequencing is required or a combination of parameters (such as: identity, content, purity, potency and safety) we apply the relevant techniques that accelerate your drug development.
SYMBIOSIS' extensive protein testing and characterization programs cover all quality attributes; from understanding protein structures through to functionality assays. Whether you require a single characterization parameter or a complete testing package we work with you to develop the right program for your requirements. Our state-of-the-art equipment ensures accurate analysis and consistent results.
The complex composition of antibodies requires the application of testing and stability programs designed specifically for each antibody. GLP and GMP certified we apply the appropriate methodology according to regulatory requirements. Our expert staff supplies all regulatory support services and provides help starting from preclinical development through market authorization.
The special nature of virus-like particles (VLPs) emphasizes the importance of using a qualified analytical partner. Certified at Biosafety Level 1 our analytical programs are designed to examine the complex structure of VLPs and vaccines. We are also authorized to work with pathogenic germs according to German and international regulations.
For companies manufacturing small molecule pharmaceutical products SYMBIOSIS provides a wide range of analytical services according to Pharmacopoeias (Ph.Eur. and USP). New chemical entities (NCE) and synthetic manufactured peptides are tested for various parameters.
The growing demand for peptide analysis requires fast and accurate analysis to meet industry demands and market requirements. Methods we have available include N-terminal sequencing, peptide mapping and mass spectrometry. These methods, in combination with our core competencies (Process, Communication and Quality), help accelerate testing and analysis.
NEW CHEMICAL ENTITIES
SYMBIOSIS offers routine release testing and stability studies for all types of NCEs. A complete range of testing parameters (such as: identity, physicochemical attributes, content and purity) is available.