Development2023-10-26T12:10:48+13:00

Chemical process development & optimization

We deliver work that is engineered appropriately.
We take milligrams to kilograms by embedding safety controls and quality procedures that de-risk your path to the clinic.

Our success comes from creating high-trust partnerships with our clients. Your chemical process development, optimization and engineering is safe in our hands.

Our team of experts thrive on creating robust, reproducible, and scalable pharmaceutical chemistry. Our highly-skilled development scientists are accomplished at de-risking the Chemistry Manufacturing and Controls (CM&C) component of drug development.

We achieve this by taking a proactive, risk-based approach to our process development campaigns. Our focus is on scaling up the process safely and providing material that meets the agreed specification.

What you can expect

An appropriate approach

Our ‘right first time’ approach provides a competitive advantage, by reducing time to market and alleviating technical and regulatory risks

Safety is our top priority

Our culture encourages individuals to contribute to and take responsibility for safety and quality

High-trust partnership

Our business is built around open and honest communication with our clients and easy access to an outstanding pool of dedicated experts

Robust processes

Since 2003, we’ve worked alongside our clients providing scientific expertise, rigorous methods, and state-of-the-art technology to solve their most complex chemistry challenges

Right quality at the right time

We solve problems by understanding our clients and what they want to achieve. Whether it’s the pre-clinical, early phase, or late phase clinical development, our scientifically trained project managers will support you from start to finish of every project.

Our people enjoy using their unique capabilities to help you navigate the path towards commercialisation. We provide a full range of services including regulatory starting materials, commercial intermediates, new chemical entities, and active pharmaceutical ingredients (APIs).

Safe, rapid and competitive scale-up of multi-step chemical processes.

Our late-stage development processes are well engineered for product, process, and personal safety. Our process development division makes sure we fully understand the often highly reactive pharmaceutical materials we are dealing with. We are experienced in putting in place the necessary engineering before we move to large-scale manufacture.

Our process development team will perform an array of experiments to identify and explore critical quality attributes (CQAs), critical process parameters (CPPs), and their acceptable ranges (scale up parameter evaluation).

Reproducibility is the name of the game. We aim to manage our chemistry and processing to control impurity burden and the physical form/characteristics of your product. Our ethos is to continuously improve the control strategies for your internal process controls (IPCs).

Our focus is also on continuous process and operator safety improvement in hazard and operability studies (HAZOP).

Our processing capabilities

Our process development labs are well equipped to handle a wide array of chemistries.

Our equipment includes:

• 5-75 L Jacketed lab-reactors (-80 to +150ºC)
• HPLC with UV, MS, CAD detection
• Design of Experiments (DoE)
• Parallel reaction screening equipment
• Crystallisation screening/characterisation
• Calorimetry
• Automated chromatography

Our purification capabilities

We have the ability to deliver a wide range of compounds to the highest purity specifications.

This includes:

• Reverse phase purification ranging from milligram to multiple batches at kilogram scale

• Biotage chromatography for large scale carbohydrate and other non crystalline products

• Tangential Flow Filtration (TFF)/Ultrafiltration (UF) for polymers and higher molecular weight product mixtures

“Our late-stage development processes are well engineered for product, process and personal safety.

We make sure we fully understand the often highly reactive pharmaceutical materials that we are dealing with, and have adequate engineering in place to handle them before we move to large-scale manufacture.”

Dr Rachel Dixon
Process Chemistry Team Leader
GlycoSyn

“GlycoSyn not only have excellent facilities supported by world class staff but importantly from a client’s perspective, understand the pharmaceutical industry needs and demanding standards from laboratory work through to process design and scale up under GMP.

This, together with not only a “can do” but a “will do” attitude has significantly contributed to our ongoing success.”

Dr Philip Marshall
CEO, Oncology Research International Limited

Some of our Success Stories

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