Scale up non-GMP
Concept Life Sciences develops scalable, innovative, safe, economical and robust processes for synthesis intermediates, target molecules and Active Ingredients (AIs). Fit-for-purpose solutions are designed to meet your urgent needs for the delivery of complex molecules on time and in full. Our highly skilled process R&D (PR&D) team enables clients to overcome complex challenges by connecting science and providing results.
Solving your R&D challenges with innovative solutions
Concept’s skilled and dedicated PR&D chemists offer a client-centric, innovative approach to problem solving.
Using SELECT and green chemistry principles, our passionate scientists will accelerate the evaluation of a synthetic route according to your timescales. Drawing upon our expertise in design of experiment (DoE) studies we can further develop existing routes 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.
As part of our collaborative approach, teams of analytical chemists and ADMET scientists are on hand, working alongside our synthetic chemists. Our analytical team design In Process Checks (IPCs) and develop methods to quickly facilitate impurity identification and fate/purge studies.
Our experienced chemistry team carries out bespoke impurity synthesis and provides cold-labeled analytical standards. Our analytical team offers purity profiling (5-batch studies), stability studies and can assess particle size and polymorphism. Method validation studies are performed in accordance with GLP, and services are tailored to client requirements with guidance on appropriate techniques and regulations.
Highly skilled ADMET scientists carry out a wide range of in-vitro screening to support the early assessment of compounds, with renowned expertise in the design, performance and interpretation of toxicology programs.
Rely on our expertise in optimization and scale up of high-pressure chemistry including hydrogenations, carbonylations and aminations. A range of stainless steel and Hastelloy pressure vessels allow synthesis ranging from parallel screening through to efficient scale-up in larger vessels.
Safety is our top priority. Before 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 conducted if these screening techniques highlight areas of concern, to ensure the process is safe before commencing scale up.
Process chemistry services
- State-of-the-art facilities
- Extensive number of reaction vessels (up to 120 L) for the manufacture of multigram to multikilogram quantities of intermediates, target molecules and AIs
- A mix of glass and Hastelloy vessels to handle more aggressive chemistries
- Vessels equipped with temperature control units and data rich processing systems to enable control and automation of industrial processes
- Polyblock Parallel Reactor Screening Technology mimics plant processes down to 10 mL scale
Process chemistry capabilities
Continuous flow chemistry:
- Team of chemists experienced in the use of continuous flow technology
- Identification of suitable reaction parameters and use of continuous flow chemistry for rapid optimization work as well as for synthesis and manufacture
- Flow technology to reduce risk when high energy or hazardous intermediates or reagents cannot be avoided
Handling high potency compounds:
- Laboratories equipped for the handling of high potency compounds
- Reaction vessels fitted with Ezi-Dock High Containment Transfer System
- Dedicated drying ovens for highly toxic materials
|Flow Chemistry||Syrris Asia modular flow apparatus with chip, tube and tube-in-tube reactors|
|Process Safety||Differential Scanning Calorimetry (DSC), Thermal Screening Unit (TSU)|
|Parallel screening||Radleys Carousel Parallel Stations, Polyblock Parallel Synthesis Reactor Technology (10 to 400 mL)|
|High pressure chemistry||Stainless steel & Hastelloy autoclaves (300 mL to 7.8 L). Bespoke inserts to allow efficient parallel screening.|
|Chromatographic purification||Biotage automated chromatography units, Counter Current Chromatography (CCC), preparative HPLC|
|Analytical||NMR, HPLC-MS, GCMS, LCMS, infra-red (IR), Chiral LC, Super Critical Fluid Chromatography (SFC), Gel Permeation Chromatography (GPC)|
|Product chemistry||Purity profiling (5-batch studies), phys/chem studies, storage stability, contaminant qualifications, interlaboratory validations, method development, verification, validation & transfer, particle sizing, formulation, reverse engineering, rheology, Differential Scanning Calorimetry (DSC, for polymorph studies), X-Ray Powder Diffraction (XRPD)|
|ADMET||Metabolite ID, test item characterization, tissue binding, physicochemical property evaluation, permeability.|