Product brochures

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 small molecule cytotoxics 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.

Cell-Based Medicinal Products are complex and require state-of-the-art analytical methodologies to evaluate their quality, safety and efficacy. Quality Assistance provides you with the scientific and technical support to develop and/or optimise these methods for use in a GxP-regulated environment.

Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product from discovery to the market place.

In order to evaluate the Quality, Safety and Efficacy of the given drugs for each client project, we design customised solutions, define analytical protocols, as well as develop and validate specific new analytical methods.

In addition, we perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies, and batch release testing.
 

Take no risk with your analytics when developing new therapeutic monoclonal antibodies.

Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product from discovery to the market place.

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.

To speed up the development and marketing of your NBEs, Quality Assistance offers all analytical services required by EMA and FDA, all on one site. Whether it is to extend your analytical capacities or outsource parts or all of your analytical needs, our skilled teams are here to support your developments for mAbs, ADCs and proteins.

NEW CHEMICAL ENTITIES (NCES)

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.

To speed up the development and marketing of your NBEs, Quality Assistance offers all analytical services required by EMA and FDA, all on one site. Whether it is to extend your analytical capacities or outsource parts or all of your analytical needs, our skilled teams are here to support your developments for mAbs, ADCs and proteins.

Vaccines are biological products that contain antigens capable of inducing a specific and active acquired immune response in the body.

The antigen may be:

• A whole organism (bacterium or virus) which has been inactivated by chemical or physical means or attenuated whilst retaining
• adequate immunogenic properties
• A microorganism subunit (e.g. protein, modified toxin, polysaccharide, polysaccharide conjugate, virosome)
• A recombinant protein (virus like particles)
• A peptide
• A nucleotide sequence that encodes for microbial antigens. It could be a plasmid (DNA vaccine) or a viral vector (live recombinant viral vectored vaccine)

Whatever the type of antigen, we can participate in your project.