Eurofins Advinus offers a full range of process research development services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development. The chemistry services are provided on both fee-for-service (FFS) and full-time equivalent (FTE) basis. Eurofins Advinus clients range from academic institutions to small biotech to big pharma, and also agro chemical companies.
Capabilities include:
- Kilo-lab and pilot-plant for process development, scale-up and production of drug substance for pre-clinical studies
- Well-equipped, QP-audited cGMP facility/capabilities to produce NCE in quantities suitable to support up to early clinical development
- An excellent scientific team of skilled, well-trained and highly experienced synthetic organic chemists, analytical chemists, and chemical engineers to follow a regulatory-driven, phase-appropriate process development strategy to support various stages of Chemistry, Manufacturing & Control (CMC)
- Experienced scientists with deep understanding of drug discovery and development to ensure speedy and flawless execution of CMC campaigns in a cost-effective manner
Chemistry Services include:
Custom Synthesis
- Gram to multi-kilo gram scale synthesis (non-GMP & cGMP)
- Focused libraries for lead generation and lead optimization
- Scaffolds, building blocks and Intermediates
- Reference and standard compounds
- Metabolite and impurity synthesis
- Stable label compounds (deuterium labelled)
- Scale-up support to DMPK and Tox studies
Process Research & Development
- Design and demonstration of innovative and sustainable synthetic routes
- Regulated starting materials, advanced intermediates, and specialty molecules with an emphasis on IP, cost, quality, safety, atom efficiency, and green chemistry
- Development of original, non-infringing and environment friendly synthetic routes for commercial manufacturing of generic APIs
- Design and development of scalable, robust, safe and cost-effective processes using systematic methodologies such as Design of Experiments (DoE) and Quality by Design (QbD),
- Process optimization to identify critical process parameters (CPP) and to obtain optimum yields and high quality of products
- Process validation studies to assure products meet specified quality parameters consistently and reliably
- Identification of potential hazards such as uncontrollable exothermic reactions, explosive reactions, unexpected release of toxic or flammable gases etc., by performing careful Process Hazard Analysis/Process Safety Assessment to eliminate unsafe operations
- Process Safety Assessment using Reaction Calorimetry (RC) and Differential Scanning Calorimetry (DSC)
- Modern equipment, utilities, and state-of-the-art scale-up capabilities to supply drug substance for preclinical as well as for clinical studies up to Phase II in compliance with cGMP
- Seamless technology transfer from lab to pilot-plant and to commercial plant for large-scale manufacturing
- Polymorph screening, identification and evaluation
- Comprehensive salt, hydrate or co-crystal screening studies
- Synthesis of metabolites and their characterization using LC-MS/ MS and NMR spectroscopy
CMC Analytical Services
Eurofins Advinus has well equipped analytical laboratories with modern and sophisticated analytical instrumentation. We offer regulatory-compliant analytical services to support Chemistry, Manufacturing & Control (CMC) campaigns that includes:
- Analytical method development and optimization as per client’s requirement or as per cGMP requirement
- Analytical method validation as per ICH guidelines
- Complete or partial method validations
- Cross-validations between two laboratories
Methods are developed to carry out following analysis:
- Reaction monitoring using HPLC, GC, LC-MS, and GC-MS
- Purity determination by HPLC and GC
- Assay determination by HPLC, GC, and Titrimetry
- Chiral purity determination by HPLC
- Residual solvents determination by headspace GC
- Potency determination of analytical standards
- Quantitative NMR analysis
- Physical and chemical tests
- Contamination carry over for project to project change over
- Assistance in validating methods and transferring them to client’s sites and ensuring reproducibility of results
- Eurofins Advinus provides services for extended stability studies under varied temperature and humidity factors, ideal storage conditions and testing stability of APIs to meet regulatory requirement
- Eurofins Advinus has the capability to perform accelerated or forced degradation studies for drug substance under acidic, basic, oxidative, photo, and thermal conditions and identify and characterize potential degradation products
- Development of methods to isolate impurities in a drug substance, regulatory starting materials, advanced intermediates, and APIs using various techniques such as flash chromatography, liquid-liquid extractions, and preparatory HPLC.
- Elucidation of structure of the isolated impurities using MS/LC-MS, and NMR spectroscopy.
- Preparation of reports for regulatory submission
- Preparation of reference/working standards of raw materials, intermediates, impurities and finished products by selecting high purity material and testing it against the available official reference/working standards.
- Qualification of reference/working standard by performing purification and characterization of the substance, in case an official reference/working standards are unavailable
ICP-MS data generation in GLP laboratory
- Facility to directly aspirate sample solutions in organic solvents
- Microwave digestion system capable of digesting variety of samples and sample sizes
- Laboratory with expertise in accurate and precise trace and ultra-trace level analyses
- Identification and quantification of elemental / metal composition in diversified sample types
- Toxicokinetic and pharmacokinetic studies requiring elemental analysis
- Analysis in support of extractables & leachables testing
- Samples for metal contaminant analysis include:
- Pharmaceuticals
- Agrochemical technical materials and other chemicals
- Crop produce – raw and processed
- Soils, sediments, etc.
- Processed food
- Feed
- Nutraceuticals
- Biological matrices, like tissues, blood / plasma, etc.
- Plastics and other polymers
- Water
- Use of reference standards with traceability to international standards
