API Development and Manufacture - Early Phase


API Development and ManufactureProcess Development

We have significant experience in the first time scale-up of APIs. Starting with the medicinal chemistry route, our knowledgeable chemists can quickly identify the most pressing parts of the chemistry to develop.

The thermal safety of each process is assessed in-house by the DSC and ARSST and the heat of reaction data is measured by calorimetry. Purity control is assured by a combination of reaction progress control and the development of an effective and scalable purification strategy.

Our biocatalysis expertise is just one approach we take to identifying ways of introducing chirality.

Our chemists work closely with our development analysts and production teams to ensure that controls are appropriately embedded into the process IPCs, intermediate specifications, and processing instructions. The salt form and polymorph landscape are explored within our physical sciences teams and drive the development of the API isolation process, and particle size is controlled through our micronisation suite.

In addition to a wide range of API structural types, our highly skilled chemists have experience working with ADC linkers, warheads and linker-warhead combinations.

Additionally, we have extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds – from drug discovery through to launch. We can label any compound at any stage, including small molecules, peptides, and antibody drug conjugates.

Expert Analytical Development

Our strong analytical teams are experienced in the development and phase appropriate validation of sensitive and specific analytical methods. Our seasoned analysts work closely with our chemists to develop IPC, isolated intermediate, and stability indicating API methods. Underpinning this work is a strong investment in a wide range of analytical equipment, including ongoing investment in equipment and software that increases the efficiency of our analytical workflows.

We have vast experience in the development of highly sensitive methods to demonstrate control of potential GTIs. Our stability teams work alongside our development analysts, routinely running multiple parallel API and drug product stability studies.


Highly Potent Manufacture

Highly Potent Manufacture
API Manufacturing Facilities

Highly Potent Manufacture

API Development and ManufactureWe have responded to the growing need for the manufacture and handling of highly potent compounds. The early development phase of a project sometimes creates a challenge for categorisation, and sufficient information is not always available to allow for a clear assessment of the exposure risks.

Our evaluation process begins with a thorough review of all knowledge of both the API and intermediates. This includes consulting with the appropriate health and safety, toxicology, and operations experts. Comparison to known compounds is used and additional testing is carried out where necessary. Clear SOPs and operating instructions are generated based on this thorough review.

With the installation of certified containment equipment, we became one of the first companies in Europe to receive SafeBridge certification. Our containment and isolation facilities allow for the handling of compounds with OELs down to 0.1 µg / m3.  We use isolators in a GMP Class 100,000 facility which features door interlocks, pressurised anti-rooms, and separate equipment and personnel movement.


API Manufacturing Facilities

We have three primary manufacturing areas for API work:

1) The non-GMP manufacture of APIs up to 1-2kg is performed in our kilolab, in reactors ranging from 30 to 100L.

2) The cGMP manufacturing of APIs up to 100kg is performed in our GMP manufacturing plant. Our reactors range from 100L to 1000L, with capabilities for hydrogenations, cryogenic chemistry, photochemistry and ozonolysis, as well as an expansive range of operational capabilities for API manufacture.

3) Appropriate containment is provided for potent compounds, including contained micronisation capability.




Highly Potent Manufacture

Highly Potent Manufacture
API Manufacturing Facilities

Highly Potent Manufacture

API Development and ManufactureWe have responded to the growing need for the manufacture and handling of highly potent compounds. The early development phase of a project sometimes creates a challenge for categorisation, and sufficient information is not always available to allow for a clear assessment of the exposure risks.

Our evaluation process begins with a thorough review of all knowledge of both the API and intermediates. This includes consulting with the appropriate health and safety, toxicology, and operations experts. Comparison to known compounds is used and additional testing is carried out where necessary. Clear SOPs and operating instructions are generated based on this thorough review.

With the installation of certified containment equipment, we became one of the first companies in Europe to receive SafeBridge certification. Our containment and isolation facilities allow for the handling of compounds with OELs down to 0.1 µg / m3.  We use isolators in a GMP Class 100,000 facility which features door interlocks, pressurised anti-rooms, and separate equipment and personnel movement.


API Manufacturing Facilities

We have three primary manufacturing areas for API work:

1) The non-GMP manufacture of APIs up to 1-2kg is performed in our kilolab, in reactors ranging from 30 to 100L.

2) The cGMP manufacturing of APIs up to 100kg is performed in our GMP manufacturing plant. Our reactors range from 100L to 1000L, with capabilities for hydrogenations, cryogenic chemistry, photochemistry and ozonolysis, as well as an expansive range of operational capabilities for API manufacture.

3) Appropriate containment is provided for potent compounds, including contained micronisation capability.