Extended Bench™ in action
Accelerating late phase development
CONTRIBUTOR:
Alexander Bissegger
Senior Project Manager
Wisconsin, US
Specialty spotlight
Chemistry and analytical development, GLP and GMP manufacturing, stability and dFMEA studies
North Carolina, US
Specialty spotlight
Early phase chemistry and analytical development, process optimisation
Cramlington, UK
Specialty spotlight
Solid state characterisation and crystallisation development, late phase chemistry, analytical development, and manufacturing
Newcastle Biosphere, UK
Specialty Spotlight
Route scouting, proof of concept, and reference standard synthesis
Wisconsin, US
Specialty Spotlight
Chemistry and analytical development, GLP and GMP manufacturing, stability and dFMEA studies
Sterling’s Wisconsin site, which specialises in full API development through to commercial manufacturing, served as the home base for this project, with a dedicated project manager to serve as the customer’s main point of contact and coordinate responsibilities across all Sterling facilities involved.
Key responsibilities for the Wisconsin site included:
Process and analytical development for the second-generation asset, ensuring robust, scalable, and reproducible routes in preparation for late phase manufacturing
Analytical method development and validation for both customer assets, ensuring alignment with regulatory standards and readiness for GLP and GMP manufacturing
Process development for the late phase material, and validation for registered GMP steps
Risk and control strategies, including nitrosamine impurity synthesis to establish sensitive detection limits, as well as Design Failure Mode and Effects Analysis (dFMEA) to identify and mitigate potential points of failure through development and manufacturing
Why it matters:
By centralising process governance and project management at the Wisconsin site, Sterling ensured that complex workstreams across multiple facilities advanced seamlessly. The Wisconsin site played a crucial role not only through supporting development and manufacturing requirements, but also by minimising communication gaps and streamlining decision-making for the customer.
North Carolina, US
Specialty Spotlight
Early phase chemistry and analytical development, process optimisation
The North Carolina site is well-known for its extensive early phase development expertise. Working in parallel with the other sites, the North Carolina team played an integral role in developing and optimising a scalable process for the second-generation material to carry through to larger scale manufacturing.
Key responsibilities for the North Carolina site included:
Process development and optimisation for the second-generation asset to ensure scalability and reproducibility
Isotope-labeled material synthesis to support pharmacokinetic assays and evaluate bioavailability of the second-generation asset
Robust early phase data generation to enable a smooth transition to Wisconsin for eventual clinical and commercial manufacturing
Why it matters:
By establishing a well-optimised and reproducible process early on, the North Carolina team helped de-risk downstream scale-up and manufacturing. Their early phase expertise and ability to generate robust data helped to accelerate the overall project timeline.
Newcastle Biosphere, UK
Specialty Spotlight
Route scouting, proof of concept, and reference standard synthesis
Sterling’s Newcastle Biosphere site provides additional early phase expertise across discovery and development, allowing them to flexibly support route scouting and proof of concept in tandem with the North Carolina site’s early phase work.
Key responsibilities for the Newcastle Biosphere site included:
Exploration and testing of alternative pathways for the second-generation asset to identify opportunities for greater efficiency and scalability
Proof-of-concept process improvements to enhance efficiency as GLP manufacturing occurred at the Wisconsin site
Synthesis and qualification of reference standards for regulatory starting material (RSM) and downstream GMP steps, enabling accurate impurity profiling and method validation
Why it matters:
The Newcastle Biosphere team’s agile feasibility work helped to de-risk the process early on, while enabling faster and more accurate decision-making for the Cramlington and Wisconsin sites down the line.
Cramlington, UK
Specialty Spotlight
Solid state characterisation and crystallisation development, late phase chemistry, analytical development, and manufacturing
With expertise in full-lifecycle development and manufacturing along with solid state chemistry, the Cramlington team played an integral role in RSM development and solid state characterisation.
Key responsibilities for the Cramlington site included:
Advanced solid state studies to define physical properties for the second-generation asset, plus crystallisation development to support consistent particle size and downstream processing
RSM method development and validation for the late phase asset to support upcoming regulatory filings
Late phase RSM manufacturing under controlled conditions to provide qualified material for GMP synthesis while ensuring process scalability
Why it matters:
The Cramlington team ensured that the programme was supported by robust controls and reliable RSM supply as activities at other sites progressed, enabling scalability and regulatory success.
An extension of your team and ours
Working together to maximise success
Sterling’s Extended Bench™ model made it possible to carry out distinct yet equally important project components in parallel, while capitalising on each site’s areas of expertise and allowing the customer to achieve their project objectives on time and within budget. At every step of the way, the customer worked collaboratively with the Sterling team through a dedicated project manager, who served as the customer’s point of contact and a coordinator across Sterling’s internal teams to ensure consistency, alignment, and rapid problem-solving.
Some key advantages of our Extended Bench™ model include:
Flexibility to allocate time and resources across Sterling’s global network of facilities and numerous areas of technical expertise
Agile responsiveness and the ability to adapt rapidly as project requirements shift
Accelerated time to market, with distinct processes run in parallel
Full transparency in resource allocation and costs
Access to multiple experts and teams across the business, while retaining one, dedicated point of contact for continued alignment without added complexity
Unlike other outsourcing models where projects simply transfer from one site to another as they progress into later stages, Extended Bench™ allows specialised teams to work collaboratively on different elements of a project and come together regularly to review progress, share insight, and maximise customer value. By unifying the customer and specialised teams under one coordinated approach, the Extended Bench™ model supports a seamless, collaborative
journey toward shared project objectives.
