With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates.
Thanks to our combined experience with cytotoxic small molecules and monoclonal antibodies, we can provide full analytical support for your projects. We offer a wide range of services for all payload categories (maytansine derivatives, auristatins, etc.) and all conjugation strategies (lysine, cysteine, site-specific).
Throughout non-clinical and clinical development, our scientific team provides you with customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.
Quality Assistance has the analytical sciences and technologies needed to support your cell therapy product development, including characterisation, development and validation of analytical methods, stability studies, batch testing and bioanalysis to support PK, biomarker, toxicity and immunogenicity studies.
Gene Therapy Medicinal Product (GTMP) means a biological medicinal product which fulfils the following two characteristics:
It contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;
Its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing new therapeutic monoclonal antibodies.
Throughout non-clinical and clinical development, our scientific team provides you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.
Nanomedicine products are highly diversifi ed in terms of structure, components, drug load or targeting moieties.
In a regulatory landscape which is not well defi ned this diversity is very challenging for drug developers who have to fully characterise and control the quality of their product and for competent authorities who have to evaluate each project on a case-by-case basis.
Each nanomedicine is unique and requires sound analytical expertise, innovative technical solutions and, above all, real extensive scientific support.
Quality Assistance provides this support, using a customized approach to help you move your nanomedicine products through non-clinical and clinical development towards registration.
With 35 years' experience in analytical science, Quality Assistance provides you with the scientific and technical support and with a state-of-the-art analytical platform for the development of your New Chemical Entity.
Our services include:
Customized solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development
A full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods
Support to solve any problems or face regulatory questions on analytics
Compliance with all applicable EMA, FDA and ICH regulations
Thanks to their potential to reach undruggable targets and their high specificity, therapeutic oligonucleotides (DNA and RNA) are a promising new family of drugs for the treatment of a variety of chronic diseases such as cancer, diabetes, AIDS and cardiovascular conditions.
Due to their relatively large size as compared to typical small molecule drugs, there are many technical challenges associated with the analysis of these molecules.
With a highly experienced staff and state-of-the-art premises and equipment, Quality Assistance is your partner of choice to overcome your analytical hurdles and facilitate the registration process.
Therapeutic peptides are at the crossroads of small molecules and proteins, requiring specific analytical packages depending on whether they are of recombinant or synthetic origin.
In both cases, Quality Assistance provides customised solutions in terms of analytical protocols and innovative technologies to help you move your peptide through non-clinical and clinical development towards registration.
Thanks to over 35 years’ experience in analytical sciences and all our laboratories (Mass Spectrometry, Physico-chemistry, Cell Biology, Molecular Biology and Microbiology) on one site, Quality Assistance covers all the analytical technologies needed to support your drug development process including protein characterisation, development and validation of analytical methods, stability studies, batch testing and bioanalysis to support PK/TK, biomarker and immunogenicity studies.