Eurofins Advinus offers a full range of process research and development services spanning kilogram scale synthesis for efficacy and toxicology studies, to multi hundred kilogram cGMP scale-up for clinical development and commercial use. Our Scientists and Process Engineers have excellent experience in developing new, safe and efficient route for complex molecules. Our scientific team is well versed with spike/purge studies, impurity identification, in silico analysis to assess Potential Genotoxic Impurities (PGIs) and developing analytical methods to quantity, process safety studies, polymorph and salt screening and QbD based process development for late phase compounds. 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:
- Route Scouting, Fit for purpose Process development and optimization, Process safety studies, Analytical method development and validation, stability studies, scale-up of drug substance for Tox and clinical studies
- Well-equipped, QP-audited cGMP Kilo lab, pilot plant and commercial production plant
- 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 hundred kilo gram scale synthesis (non-GMP & cGMP)
- Focused libraries, 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 robust synthetic routes
- Phase appropriate process development and optimization
- Impurity isolation, identification and synthesis
- 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 Tox, clinical studies and commercial use
- 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
- 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
