Making sense of hazard evaluation
05th Jul 2021
Proactively overcoming risks through an integrated hazardous chemistry approach.
Transitioning projects from lab scale to commercial scale brings about an enhanced potential for risk and an entirely new set of process safety considerations. With rising molecule complexity and the prevalence of multi-step processes in API development today, the need for a partner with comprehensive risk evaluation capabilities and full-lifecycle expertise is more important than ever before. With an experienced, full service partner, pharmaceutical and biotechnology organisations can mitigate risk at every stage of their project, ensuring optimal safety from early phase development through to full commercial manufacturing.
70% of pharmaceutical companies cite risk management as a key characteristic upon which to evaluate CDMOs.
Hazardous chemistry challenges and the need for complete continuity
Hazard evaluation is not an isolated task in pharmaceutical development and manufacturing. Instead, it requires an integrated and collaborative approach. Often, although a project may have a low risk profile at lab scale, commercial scale-up can create significant added risk. Close alignment between hazard evaluation, engineering, chemistry and analytical teams, as well as the customer, is required to proactively assess and address risk, and ensure the ongoing safety of a project throughout its entire lifecycle.
An integrated hazard evaluation approach for full-lifecycle safety
Hazard evaluation is a critical initial step in any API development project, but process safety requires continual, proactive risk mitigation and reassessment. By working with a full-lifecycle partner, pharmaceutical organisations can ensure the safety of their project at every stage.
Here’s how your partner should work to enhance safety throughout your entire programme:
At the onset of every project, hazard evaluation is critical to ensuring ongoing process safety at every stage, no matter the projected scale. Assessing potential hazards early on helps to proactively anticipate and address hazard-related issues that might arise in the project’s later stages while maximising ongoing efficiency. Hazard testing should assess the potential for explosion, ignition, heat release, and more, and identify ways eliminate or minimise these hazards.
An average chemical process involves between 20 and 40 operations , many of which may involve hazards.
Collaboration between the hazard evaluation team, development chemists, and process engineers is essential in order to design safe and scalable manufacturing processes. Quality by Design (QbD) is a critical element of drug development, which acknowledges the integral role of process design in laying the groundwork for outstanding quality and safety. Partners that offer asset flexibility are best suited to accommodate hazardous processes in complex, multi-step programmes, particularly as they scale up.
Quality by Design (QbD) became mandatory for NDA filings in 2013.
As the project moves through development and manufacturing, process optimisation may call for additional hazard evaluation work. Whenever process changes are introduced, additional assessments are required to ensure ongoing safety. In addition, an outsourced partner should maintain consistent communication with the customer, advising them on any potential process changes or new safety considerations.
74% of drug manufacturers agree that successful safety audits are a critical attribute when evaluating their outsourced partner.
Comprehensive hazard evaluation from a true scientific partner.
An integrated and collaborative approach to hazard evaluation is integral to your project’s ongoing safety. At Sterling, we deliver the expertise and equipment needed to maximise safety at every phase of development and manufacturing, including capabilities like thermal stability testing, reaction calorimetry, and explosion testing, with the flexibility to support a diverse range of process requirements in-house. Most importantly, as a PDMO®, or partnership development and manufacturing organisation, we deliver the full-lifecycle support needed to maintain full confidence in the quality, integrity and safety of your programme from grams to tonnes.
Service
We pride ourselves on being easy to do business with, removing layers of complexity, maximising flexibility and adaptability to your requirements, and doing what we say we will do, again and again.
Passion
We promise to treat your molecule as our own, drive progress by continually exploring new and emerging capabilities, and do the right thing for our people and planet.
Science
We combine our expertise in complex and hazardous chemistry, our world-class facilities, and our full-lifecycle capabilities to place scientific excellence at the core of every solution we deliver.
