Glycosyn - Research and Development for the Production of Active Pharmaceutical Ingredients and Drug Development Programmes

GlycoSyn is a business unit of Industrial Research Limited (IRL), and works closely with biotechnology clients around the globe to ensure high quality and fast-paced development of high-value small molecules.

Drawing upon world-class people, skills, facilities and equipment, GlycoSyn is your first-choice partner for the development and production of complex active pharmaceutical ingredients (APIs) and for pre-clinical and clinical drug development programmes.

Online sales division for custom synthesis of carbohydrates

GlycoFineChem is the online sales division of GlycoSyn offering custom synthesis of carbohydrates and speciality compounds from mg to kg, products include carbohydrates, inositols, azasugars, natural products and microbial secondary metabolites. GlycoFineChem is the exclusive suppler of Allosamidin and the only commercial supplier of Kifunensine.

Allosamidin is an inhibitor of both insect and bacterial chitinases. Recently Allosamidin has been reported to be an inhibitor of acidic mammalian chitinase an observation which may have implications in the treatment of asthma.

Kifunensine is a potent and selective inhibitor of class 1 alpha mannosidases, an important inhibitor of glycoprotein biosynthesis that is commonly used in cell culture. GLycoSyn is the world’s only commercial manufacturer of this product via a patent-protected process.

Discovery services, synthesis and drug design

GlycoSyn’s discovery division comprises more than 35 PhD qualified synthetic organic chemists with wide ranging experience in carbohydrate, small molecule organic and peptide syntheses, rational drug design, and route selection. The discovery group provides custom synthesis services and can be engaged to assist with the selection, optimization and small-scale syntheses of lead drug candidates.GlycoSyn discovery division also has specialised capability in building custom chiral chemistry libraries.

Glycosyn provide discovery services for:

• Custom synthesis of carbohydrates, peptides and small molecules
• Rational drug design, route selection and lead optimization
• Bench scale synthesis to produce material for pre-clinical development

Chemical process and analytical development

GlycoSyn’s process development division comprising eight chemists and engineers (seven with PhDs), focuses on the safe, rapid and cost-effective scale-up of multi-step chemical processes. Prototype manufacture in one of GlycoSyn’s pilot laboratories provides larger quantities of drug substance for pre-clinical evaluation with full supporting documentation to facilitate subsequent clinical manufacture.

This work is closely supported by the analytical team which provides in-process control and final product method development expertise. These analytical methods are validated to meet ICH requirements for APIs in clinical development.

Process and analytical development services include:

• Transition of gram scale synthesis to kilo-scale manufacture
• Route and process optimisation to achieve robust, scaleable and efficient syntheses
• Reaction calorimetry for process safety
• Prototype kilo-scale manufacture to produce material for non-human toxicology and pre-clinical development
• Batch production documentation for regulatory compliance and complete product traceability
• Analytical method development
• Impurity analysis and interrogation
• Glucuronide metabolite synthesis for analytical standards

GMP manufacture

GlycoSyn's GMP manufacturing division has experienced chemists, engineers, quality assurance, analytical and support personnel with expertise in the manufacture of GMP carbohydrates, small molecules, and peptides.

We operate under stringent international chemistry, manufacturing and control protocols to ensure the highest standards for the manufacture of small molecules for use in human clinical trials.

GlycoSyn’s quality assurance unit ensures that all products manufactured by GlycoSyn for clinical use meet strict international regulatory standards (ICH Q7). A continuous improvement programme ensures that GlycoSyn’s quality systems are the subject of constant review to maintain rigorous control in an ever-changing global regulatory environment.

GlycoSyn can manufacture GMP carbohydrates and small molecules at the gram, to multi-kilogram scale to produce material for pre-clinical and clinical requirements.

GlycoSyn also has a GMP manufacturing facility dedicated to the synthesis of multi-gram quantities of GMP peptides for use in early phase clinical trials.

GMP manufacturing services:

• Gram to multi-kilogram GMP manufacturing
• Regulatory compliance to international GMP (ICH Q7) standards
• Analytical method validation, raw material testing and release, in-process-controls and final product testing and release
• Certificates of analysis and compliance for all GMP products
• ICH stability studies
• Chemistry, manufacturing and control documentation to support IND filing
• Technology transfer