Services

Discovery

GlycoSyn’s discovery division comprises more than 30 PhD 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, optimisation and small-scale syntheses of lead drug candidates.

Discovery Services:

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

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 a six-strong 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:

• 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 consists of 14 highly 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

GlycoSyn also offers metabolite services with repsect to synthesis of drug metabolites and, in particular, chemical or enzymatic glucuronidation.

We provide signficant expertise in peptide services, with the ability to synthesise mg to several 100g quantities of peptide.