BOS cmc virtual 2021
Virtual
Quality Assistance will attend the Biotech Outsourcing Strategies Virtual Conference
BOS virtual 2021 brings together stakeholders in pharmaceutical R&D outsourcing to share experience, develop knowledge and skills and build new and existing business partnerships.
With more than 35 years’ experience, Quality Assistance has become a leader in analytical sciences and holds a unique position on the market with all its laboratories on one site and 220 highly qualified professionals. Whether it is to extend your analytical capacities or outsource parts or all of your analytical needs, our skilled teams are here to speed up the development and marketing of your Small Molecules and Biologics.
We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.
We are the one-stop shop for analytical services in a GMP, GLP, GCLP/GCP environment.
Meet Cécile Montagne and Louis Lefebvre virtually and access our latest posters:
This approach was used in the development of chromatographic methods for the separation of mAb subunits. Nivolumab was used as a case study. Working at subunit level using an enzyme such as IdeS (FabRICATOR®) allows for a better chromatographic resolution between the different species (including post-translational modifications) and a better mass accuracy when MS detection is used.
Oligonucleotides are synthetised by a chemical process. Despite extensive purification steps, it is impossible to reach total purity: an oligonucleotide sample does not only contain the oligonucleotide of interest of a given length n but also oligonucleotides of unwanted length, such as n-1 oligonucleotides (i.e. lacking one nucleotide). In order to determine the exact composition of an oligonucleotide sample, three types of high-performance liquid chromatography (HPLC) methods were evaluated:
- reversed phase chromatography with ion pairing (IP-RP)
- hydrophilic interaction liquid chromatography (HILIC)
- anion-exchange chromatography (AEX).
