Stability Testing of Drugs

Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...

Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC ex...

Providing Analytical method development, validation and stability study from Phase I-III to commercial prodcution and registration.

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 ana...

Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every locatio...

We deliver responsive QC analysis for complex biologic products from our cGMP laboratories. Our scientists develop and validate methods or perform technology transfer of a sponsor's method for a wide range of analytical methods required for batch release testing. We also routinely carry out testing to Phar...

Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, ...

Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel...

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 ...

Thanks to 35 years’ experience in analytical sciences and all our laboratories on one site (Mass Spectrometry, Physico-chemistry, Cell Biology, MolecularBiology and Microbiology), Quality Assistance covers all the analytical technologies needed to support your drug development process i...

Quality Assistance covers all the analytical technologies needed to support your drug development process: CMC (Quality) studies to be perfomed, including Ab characterisation, development and validation of analytical methods, stability studies and batch testing. For Bioanalysis to be performed in Non-clini...

Allyone's Stability Chambers have a reputation to quickly achieve & maintain the defined setpoint to simulate the condition perfectly & flawlessly with extraordinary control on both Temperature & Humidity along with outstanding uniformity.

Our Stability Chambers are conceptual...

Allyone has a long & rich experience of manufacturing state of the art Cooling Cabinets/ Cold chambers which are the most trustworthy equipment maintaining the exact set point, assuring absolute uniformity as they are meticulously designed & built for optimum performance keeping in mind environment...

As the evaluation of stability is a critical aspect of drug substance and drug product testing, Integrated Analytical Laboratories offers Stability Services and Sample Testing to our partners.  Whether you have predetermined stability protocols or require IAL to develop the protocol, IAL will be an im...

• Premium Extracts – for your project Our extract portfolio includes both extracts in line with the ISO 22000 and/or Ph.Eur monograph for the pharmaceutical industry, and extracts for the food industry. From A for Althaea (marshmallow) to V for Vaccinium (cranberry) - we offer you a sophisticated and inn...

Inkemia IUCT Group offers a wide range of services which includes isolation and characterization of impurities. Features: it includes development and validation of analytical methods for determining related substances; impurity profiling; getting forced degradation impurities; isolation and purification of...