Early Scale Up

As a project moves from discovery to development, designing a safe, scalable and robust process is critical to maintaining high quality standards across the entire molecule lifecycle.

We know that decisions made early in an active pharmaceutical ingredient’s journey through clinical trials can have lasting impacts down the line. At Sterling, our multidisciplinary approach to early scale-up brings together team members specialising in chemistry, analytical services, solid state, hazard evaluation, and even engineering, enabling us to proactively consider and address challenges that might arise as a project continues to scale. We support our customers in developing a robust process that will stand up to scrutiny.

Explore our early scale-up capabilities below:

Our experience across a range of syntheses enables us to identify the most efficient, cost-effective, safe and scalable route to produce a desired compound, while maximising quality, purity and yield. During route scouting and selection, we generate and evaluate a variety of synthetic routes to develop a target compound, then select the one that most reliably achieves the intended result while accounting for our customers’ key project requirements.

With more than 50 years of expertise in complex chemistry, we’ve successfully developed processes for a broad range of API development projects. We identify potential impurities, side reactions and other challenges, then take measures to optimise reaction conditions to mitigate them. Our proven process development approach accounts for process safety considerations, scalability, sustainability, project timelines and more.

Toxicology studies are critical to assessing safety and potential toxicity of an API prior to entering clinical trials. We support our customers in developing initial non-GMP supply that contains costs early on while reliably producing safety data.

As a project prepares to scale, we perform risk and process safety evaluations to ensure ongoing consistency, reliability and safety. We collaborate closely with our customers to meet their desired timeline.

Once a project progresses to clinical trials, we apply extensive expertise in GMP manufacturing to develop high quality, low volume material. Our facilities in Cramlington, UK, Wisconsin, US, and North Carolina, US have cGMP kilo labs from 10-100L capacities to produce API batches for early clinical studies.  If your project requires pilot or large scale manufacturing this can be accommodated at our Cramlington, UK, Wisconsin, US and Cork, Ireland facilties.

To help our customers achieve the optimal solid form of their API with enhanced solubility and bioavailability, we deliver extensive expertise in solid form investigations and crystallisation development. Our experienced solid state chemistry teams and range of state-of-the-art equipment enable us to identify an ideal solid form during API development. In addition, our Cramlington, UK facility is home to a dedicated Material Science Centre.

Across our global facilities, our solid state services include:

• Salt / cocrystal screening
• Polymorph screening
• Pre-formulation evaluation
• Crystallisation development
• Milling and micronisation

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