Linker payloads

At Sterling we can support your linker payload project through early preclinical to GMP clinical and commercial manufacture; developing processes with full method development testing and release.

We are equipped to support a range of project requirements for these complex molecules, including cGMP purification and lyophilisation.

Design and proof of concept

We can support linker payload design using both a literature precedented approach and internal experience to find the optimal way to attach your payload to the right linker. We understand that at this early stage, customers are looking to fail fast to find their lead drug conjugate quickly, with the optimal linker and payload. We can provide rapid synthesis of milligram scale quantities of bespoke linker payloads for proof of concept conjugation work. We have experience across a broad range of drug conjugates including antibody drug conjugates (ADCs), protein degraders, peptide and polymer drug conjugates.

Process development

We can support both process and analytical development of your linker payload from milligram scale to grams. At Sterling, we have development capabilities ranging from route scouting and design, through to process optimisation and full validation support, including quality by design and design of experiments.

Our fully equipped process development labs allow us to handle ultra high potency payloads with containment down to <1 ng/m³, with fully contained weighing, dispensing, reaction, work-up, isolation and drying. We have a range of purification options including automated flash chromatography and prep HPLC, and lyophilisation.

Once development is complete, we have the ability to seamlessly transfer your project to GMP manufacturing.

Manufacture

Our team can provide linker payload cGMP manufacture from <100g to 10kg scale.

• Isolator containment validated to OEL <1ng/m³ (surrogate testing demonstrated)
• Gowning and de-gowning
• Multilayer facility controls with pressure cascades and downflow booth migration control
• Dedicated utilities
• Weigh/dispense/dissolve
• Integrated solution charge to current process capabilities
• Contained packaging
• Small-scale single-use production capabilities within
• Normal and reverse phase chromatography with high (up to 100 bar) and low pressure systems with integrated PAT
• Fully contained GMP lyophilisation (30L at -85°C)

Safety

Highly potent API manufacturing requires stringent safety standards as well as specialised facilities and equipment. Our Wisconsin, US site is equipped with two high containment cGMP manufacturing suites that are purpose-built for the safe handling of HPAPIs. These suites are FDA approved and capable of handling batches up to 10 kilograms while adhering to regulatory requirements around the world.