Commercial API Lifecycle Management

Below are some key areas that can present challenges for innovative pharmaceutical organisations as their API matures:

Once a drug has been commercialised, the drive to continually improve processes does not end, as margins tend to become tighter later in a molecule’s lifespan. Pharma organisations should seek to partner with a CDMO who is constantly seeking to optimise processes, creating cost efficiencies through improving yields and timelines without compromising on quality.

As an API progresses through its commercial lifecycle, supply chain resilience becomes a key competitive advantage. Pharmaceutical companies need a CDMO capable of delivering consistent product quality and reliable supply, supported by a robust, qualified supplier network and proactive risk management.

Manufacturing flexibility is equally as important; CDMOs require capabilities to scale production to meet demand fluctuations and ensure business continuity in an increasingly dynamic and uncertain global environment.

As innovative APIs transition into long-term commercial manufacturing, regulatory strategy is an integral part of lifecycle management. Process optimisations, tech transfers, supplier changes and second-generation process improvements all require careful regulatory planning. Pharmaceutical companies should collaborate with a CDMO that combines an excellent inspection history with extensive experience supporting post-approval changes, global regulatory submissions and market-specific requirements, ensuring compliance and continuous improvement throughout the product lifecycle.

As a molecule nears the ‘patent cliff’, customers will often seek opportunities to extend patent life or exclusivity periods. They should select a CDMO partner who can reliably support second generation programme development, offering robust process optimisations and cost efficiencies, as well as knowledge, expertise and advice based on extensive experience, to support innovation and the identification of appropriate opportunities.

At Sterling, we collaborate with our customers throughout the entire drug substance lifecycle: from preclinical development and scale-up through to commercial launch. As products mature, we continue to optimise manufacturing processes, strengthen supply chain resilience, improve cost competitiveness and support regulatory drug lifecycle management, helping customers maximise the long-term value of their APIs.

Sterling supports its customers as their API matures and progresses towards patent expiry and generic launch through the following:

Lifecycle management

Sterling’s full lifecycle management approach provides long-term support for commercial programmes, by developing robust, cost-efficient second-generation processes. This ensures that our API manufacturing remains effective, scalable and compliant as markets evolve, while safeguarding consistent product quality and secure, competitive supply, which are both integral for maintaining commercial momentum post launch.

Our API lifecycle management services include supply chain management to mitigate risk, dedicated GMP capacity for both innovator and generic API manufacturing, and integrated on-site analytical services to accelerate change. This is all backed by over 50 years of expertise in complex and hazardous chemistries.  Our integrated capabilities for development and scale up, including tech transfer, process optimisation and regulatory support, give our customers confidence in the long-term sustainability of their API supply.

Post launch, our team can explore different opportunities to improve costings and manufacturing efficiencies, without deviating from registered processes or risking product quality.

During API maturity, we can also explore alternative second-generation processes, which may allow for further significant cost efficiencies as the branded drug progresses towards patent expiry.

Supply chain resilience

Sterling works closely with customers to strengthen each area of their supply chain. Together, we qualify suitable raw material suppliers, ensuring they meet the required standards for quality, reliability and regulatory compliance. This includes evaluating potential suppliers based on long-term material availability and identifying potential vulnerabilities before they impact our customers’ production timelines.

Read our blog on redefining procurement in CDMO supply chains, with our Vice President of Global Procurement, Chris Neasham.

Supporting sustainability commitments

We are committed to protecting our people and planet, and this is reflected in the way we operate our facilities. Across our network, we run various initiatives to increase energy efficiency, apply green chemistry principles, identify opportunities for solvent recovery and ensure all waste is managed responsibly. These improvements not only reduce our environmental impact, but by recovering and reusing solvents on-site, we help customers build a more resilient supply chain. Through these efforts, we can reduce dependence on external vendors, helping to limit supply chain risk and stabilise cost, all while supporting customers’ ESG goals and achieving greater efficiency within their processes.

Read more about our sustainability efforts. 

Six integrated facilities

To further reduce supply chain risk, Sterling can provide alternative sites within the same network to support dual sourcing API manufacture. With six global GMP facilities spread across the US, UK and Ireland (EU), our geographically diverse manufacturing sites safeguard supply against geopolitical shifts and supply chain disruptions. This also supports business continuity planning, giving our customers the confidence that their API can be supplied consistently, in the event of force majeure or during market uncertainty.

With multiple western facilities and flexible capacities, Sterling is ideally positioned to manage and support right-sized, flexible campaign-based production, as well as overflow manufacturing as demand peaks.

Find out more about our network of global facilities.

Extended Bench^™

Our Extended Bench™ model provides flexible access to scientific resource as a project evolves and requirements change. Whether the requirement is for parts of a project to be carried out in parallel, or within specific geographies, or customer priorities shift towards something new, this model provides assurances around flexibility and adaptability, when the unexpected arises.

Find out more about our Extended Bench™ model.

Regulatory support

We provide regulatory support during every stage of the molecule’s lifecycle, applying insights from development to later stage commercial requirements to ensure long-term success.

Our six global GMP facilities have an excellent regulatory track-record and are by regulatory authorities including the FDA, MHRA, HPRA, K-FDA, PDMA, DEA and others. This strong compliance record enables us to support customers’ regulatory filings across multiple geographical markets.

Our dedicated regulatory teams proactively monitor evolving global guidelines, providing customers with early visibility into changes that may affect their projects post-launch. In the event a customer’s process was impacted by evolving guidelines, we would work closely alongside them to develop a comprehensive post-approval change management strategy to ensure market continuity.

Find out more about our quality and regulatory track record.

Innovation and continuous improvement culture

Sterling fosters a culture of innovation and continuous improvement across our organisation, empowering employees to identify opportunities to enhance processes at every stage in the molecule lifecycle.

We can support customers in optimising their maturing API manufacturing projects, assessing and adapting processes to improve yield while maintaining compliance, strengthening supply chain, and designing more efficient and scalable development routes.

When our customers look to extend an existing patent’s life, generate new IP or improve their API cost, whether through lifecycle management, second generation process development or existing process improvements, our experienced teams can provide the technical and scientific partnership required to fully realise these opportunities.