The road to optimisation: three key pillars of process improvement

Author: Susan Daly, Process Improvement Manager

Susan Daly, Process Improvement Manager at Sterling Pharma Solutions, has a PhD in Organic Chemistry from Newcastle University. She began her career as a Development Chemist before holding roles in business development, strategic planning and research and development (R&D) management. In 2017, Susan joined Sterling as a Partnership Manager before going on to lead the process improvement team in 2019 as Process Improvement Manager.

Below, Susan discusses the three key pillars of process improvement: operational efficiency, waste reduction and cost of goods reduction.

Continuous process improvement is paramount in API development and manufacturing in order to satisfy high customer expectations, streamline complex operations and mitigate waste.

While customers may not always have visibility into the inner workings of process improvement, contract development and manufacturing organisations (CDMOs) that take a pragmatic approach to process improvement can enhance operational efficiency to serve as a more reliable partner and continually enhance customer success. Read on below to discover three key aspects of process improvement.

On-time delivery is a top priority for organisations when working with an outsourced partner, with pharmaceutical manufacturers in the small molecule space citing it as a key rising priority in their CDMO selection criteria. By identifying ways to continually enhance efficiency and streamline manufacturing, outsourced development and manufacturing partners can support stringent project deadlines while maintaining high standards of quality.

The Theory of Constraints, a common process improvement approach introduced by Dr. Eliyahu Goldratt in his novel The Goal, provides a useful framework for enhancing efficiency by removing limiting factors. It outlines logic for eliminating the most significant bottleneck in a project, starting by identifying the primary constraint and making incremental adjustments on an ongoing basis. The approach advocates identification of the constraint, then management and eventual improvement to break the limitation. Then, one moves onto the next limiting factor in the process and repeats. A constraint may be a specific methodology, resource or even a piece of equipment.

For example, consider a project that requires three different pieces of equipment. Harnessing a data-driven approach, we can isolate and evaluate which piece of equipment consumes the most time. Then, small adjustments can be made until the constraint is mitigated or removed altogether. Is there a way to make the equipment work faster? Do we have an alternative piece of equipment that can be used in its place? These considerations allow the organisation to seek opportunities for improvement that uphold ongoing quality while also reducing process time. Once the constraint is mitigated, the associated process should be evaluated on an ongoing basis to understand the impact of changes and pursue ongoing improvements.

Waste reduction is another key component of process improvement, with implications that are both environmental and operational. By harnessing a focused approach to waste reduction, pharmaceutical manufacturers can optimise resource utilisation, including physical resources as well as time and effort, while maintaining high levels of quality. Lean Six Sigma, which combines principles of Six Sigma and lean manufacturing, strives to reduce or remove activities in a process that do not add value for the end customer and represent a source of waste. This methodology enables organisations to systematically identify waste drivers, reduce variation and identify opportunities for continual improvement.

In addition to the financial and efficiency gains that naturally result from waste reduction, it also offers significant environmental advantages. By reducing the number of process inputs for a given project, organisations can also reduce the amount of associated physical waste. In addition, novel technologies like flow chemistry can play an important role in minimising process waste or making it more suitable for recovery and reuse. Recently, Sterling initiated a project to optimise the treatment of waste streams from processes involving tetrahydrofuran (THF).

To do so, the team developed a flow process that would efficiently reduce hazardous impurities within the waste to trace amounts, making it acceptable for treatment in the near-term and potential reuse in the long-term. The advantages of this approach are multifaceted, as it results in cleaner, potentially recyclable waste, while reducing treatment time and freeing up batch reactors.

Where process waste cannot be reduced, organisations should ensure any of the waste that is generated is properly treated and recycled wherever possible. In some cases, like with precious metal catalysts, waste can often be recovered to gain back metal value. By pursuing the most environmentally suitable alternative for recycling, recovery and disposal, outsourced partners can simultaneously reduce environmental impact and control costs on behalf of their customer.

Pharmaceutical development and manufacturing processes tend to involve a multitude of steps and inputs, and determining ways to streamline the process or increase yield can enable significant efficiency gains and cost benefits. It is important to note that the removal of production steps and the reduction of raw materials often go hand in hand, resulting in even greater cumulative cost savings.

When key cost drivers are identified, working closely with the procurement team is crucial to review sourcing options, as well as with the R&D team to look to identify suitable alternatives.

Minimising process inputs or altering steps cannot be done without due consideration. Lab work and analysis are important for justifying and validating any process changes, particularly from a regulatory standpoint. An experienced partner should harness process data to uncover opportunities to reduce material input, identify less costly alternative materials, or increase yield.

When pursuing COGs reductions, it is critical to maintain transparency with the customer, engaging them around potential process changes and providing the data necessary to ensure compliance.

How does process improvement benefit the customer?

While process improvement can be initiated internally or by the customer, incremental improvements ultimately benefit customer programmes by reducing timescales and costs whilst improving efficiency and environmental sustainability. A dedicated process improvement team and robust, data-driven methodology allow an outsourced partner to not only meet, but also exceed, customer expectations.

In any process improvement undertaking, the customer should always come first. With a dedicated contact to serve as the customer’s voice on site, and an experienced team focused on maintaining full transparency, organisations can continuously improve internal processes in a customer-centred manner.

Optimising processes to enhance your success

At Sterling, through our dedicated team and commitment to true scientific partnership, we pursue continuous process improvements to drive tangible advantages for our customers. We view our process optimisation efforts as a natural extension of our commitment to removing layers of complexity and attaining the highest levels of efficiency and quality in every programme that enters our facilities. Read our blog for an example of how implementing a new metering approach enabled us to enhance efficiency for our customers. If you’d like to discover how Sterling can support your specific project requirements, speak to an expert.