Process research and development and pre-clinical API manufacture
Concept Life Sciences Process R&D team takes pride in developing scalable, innovative, safe, economical and robust processes for the manufacture of both regulated and non-regulated intermediates, registered starting materials (RSMs) and APIs (Drug Substance). We supply fit-for-purpose solutions to meet our clients’ urgent needs for the delivery of complex molecules on time and in full.
Accelerate the evaluation of a synthetic route
Timely engagement with our scientists will accelerate the evaluation of a synthetic route using SELECT and green chemistry principles. We can further develop existing routes drawing upon our expertise in design of experiment (DoE) studies to ensure reactions, work-ups and isolations are fully optimized. We confirm that processes are robust by stressing process conditions and defining hold points. The Concept team can successfully de-risk chemistry packages; guaranteeing that routes and processes are safe, scalable and appropriate for the stage of development.
Working alongside the team of chemists, we have teams of analysts and pharmaceutical development scientists. Our analytical team design In-Process Checks (IPCs) and develop methods to facilitate impurity identification and fate/purge studies. Our chemistry team carries out bespoke impurity synthesis and can provide cold-labeled analytical standards. The pharmaceutical development team supports form control studies and assess particle size and polymorphism, as well as designing and carrying out salt screening studies. Our formulation scientists can offer comprehensive pre-formulation and formulation development studies to further de-risk your drug development program.
In addition to evaluating the chemistry and pharmaceutical properties, CLS offers Drug Metabolism & Pharmacokinetic – pharmacodynamic relationship (DMPK) capabilities to determine Pharmacokinetics (PK), Maximum Tolerated Dose (MTD) and Dose Reduction Factor (DRF). We can also provide preliminary safety assessments to control the risk of on- and off-target pharmacology.
Dedicated Process R&D chemists
Concept Life Sciences provide skilled and dedicated Process R&D chemists who offer an innovative approach to problem solving. Within our state-of-the-art facilities there are an extensive number of reaction vessels (up to 120-L) catering for the manufacture of multigram to multikilogram quantities of intermediates, registered starting materials and drug substance APIs. A mix of glass and Hastelloy vessels allows our team to handle the more aggressive chemistries.
These vessels are equipped with temperature control units and data-rich processing systems to enable control and automation of industrial processes. With our Polyblock Parallel Reactor Screening Technology we can mimic plant processes down to 10 mL scale.
Concept Life Sciences also has a strong offering when it comes to optimization and scale up of high-pressure chemistry including hydrogenations, carbonylations and aminations. A range of stainless steel and Hastelloy pressure vessels allow our teams to carry out synthesis ranging from parallel screening through to efficient manufacture in large vessels.
Before our team will initiate scale up, special attention is given to process safety. Desk screening to identify high energy functional groups followed by Differential Scanning Calorimetry (DSC) and Thermal Stability Unit (TSU) testing will be carried out as and when required.
Further testing, for example, adiabatic or reaction calorimetry, will be carried out if these screening techniques highlight areas of concern, to ensure the process is safe before commencing scale up and manufacture.
Continuous Flow Chemistry:
CLS has a team of chemists experienced in the use of continuous flow technology. They are able to identify suitable reaction parameters and use continuous flow chemistry for rapid optimization work as well as for synthesis & manufacture. Flow technology can also be used to reduce risk when high energy or hazardous intermediates or reagents cannot be avoided.
Handling High Potency API (HPAPI):
CLS has dedicated laboratories and containment systems equipped with drying ovens which allow for the manufacture of High Potency APIs (HPAPI). Furthermore, a number of our reaction vessels are fitted with the Ezi-Dock High Containment Transfer System for the safe transfer of highly toxic HPAPIs used in the pharmaceutical & bio-pharmaceutical industry.
Bioanalysis and biomarkers
Cleaning validation and verification
Clinical and commercial manufacturing
Contaminants and foreign bodies
GXP analytical method development, validation and transfer
Out of specification investigations
QC release and GMP release testing
Storage stability studies