To be successful, pharmaceutical innovators and biotech organizations need to optimize production and achieve higher yields of their active pharmaceutical ingredients to make products more cost-effective. To realize these results, proper scale optimization is vital.

Q: What does a typical scale optimization project involve?

A: Basically, scale optimization involves improving and optimizing the manufacturing process of pharmaceutical products, with the goal of increasing production efficiency, reducing costs, and ensuring consistent product quality.

Key aspects of every project include a comprehensive analysis of the existing manufacturing process, an assessment of scale-up considerations, process optimization to maximize productivity and minimize variability, technology evaluation, risk assessment and mitigation, validation and regulatory compliance, implementation, monitoring, and strategies to ensure continuous improvement over time.

In addition, there’s a lot of multi-departmental collaboration throughout the entire project. Our cross-functional teams include process engineers, scientists, quality control experts, regulatory specialists, and manufacturing personnel to ensure success.

Q: What are the various steps in the project?

A: Process research and design are the most critical stages because they ensure the development and manufacturing of high quality, safe and effective drugs.

Process research involves exploring new technologies and methods that can be used to manipulate chemicals in compounds to create new drug products. This may focus on developing new methods of synthesis or improving existing manufacturing processes.

Process design, on the other hand, involves taking the results of the process research and designing processes that can efficiently and effectively produce the API on a large scale. That involves selecting appropriate equipment, defining critical process parameters, and setting quality standards that ensure that each batch produced is a high quality during the process research phase. Chemists and researchers work together to understand the chemistry of the compounds and identify potential routes to synthesis. They also use computer modelling laboratory experiments.

Another approach is to enhance the synthesis process to ensure that it is safe and effective. Process engineers and chemists work together to design the manufacturing processes for the API determine where it can be optimized and establish critical process parameters — the points in the manufacturing process that have the most significant impact on quality. These must be carefully controlled to ensure the safety and efficacy of the drugs produced.

Q: How much scale optimization work happens after a product has been approved?

A: That depends on the specific drug product being produced and the scale of production required. If the current process is inefficient or produces a low yield, it may require significant optimization. On the other hand, if the manufacturing process is already fairly efficient, the scale optimization may be more focused on fine-tuning the process to improve yield or reduce costs. Scale optimization can also be an ongoing process as new technologies and methods are developed.

Q: What’s the difference between scale optimization and route scouting?

A:  Route Scouting Scale optimization is about making an existing active pharmaceutical ingredient manufacturing process more efficient. It aims to improve the process so that it yields the desired outcomes while minimizing costs and environmental impact, as well as ensuring that the produced batch meets regulatory requirements.

on the other hand, is focused on identifying new ways of synthesizing an API. This happens in the early stages of development when researchers aim to determine the most efficient and cost-effective process. In route scouting, various options are proposed and explored to identify the most optimal way.

In summary, scale optimization focuses on improving an existing process, while route scouting aims to find a new and better process. In both cases, the goal is to ensure the optimization of manufacturing processes, resulting in high quality drugs that meet regulatory requirements.

Q: What specific challenges do you typically face with new chemical process development?

A: There are quite a few. I’ll try to summarize them quickly.

At the top of the list are process control and quality assurance. These are crucial to maintaining consistent quality in every pharmaceutical manufacturing process. Developing robust process control strategies and implementing quality assurance measures throughout the chemical process development are demanding but essential tasks. They include monitoring critical process parameters, implementing analytical techniques, and ensuring batch-to-batch consistency.

Ensuring the safety of the chemical processes and compliance with regulatory requirements are also critical challenges. Pharmaceutical companies must adhere to strict quality standards, Good Manufacturing Practices (GMP), and environmental regulations. It’s our job to ensure they can demonstrate the safety and efficacy of the processes and products to regulatory authorities.

Moving from laboratory-scale to large-scale production is another significant hurdle. Every process must be scalable to meet the demand for commercial production while maintaining product quality and consistency. Factors such as equipment design, raw material availability, and process control need to be considered during scale-up.

Then there’s time to market. The pharmaceutical industry is highly competitive, and getting new drugs to market quickly is essential. Developing and optimizing chemical processes within tight timelines requires efficient project management, collaboration between different teams, and effective communication.

Cost is always a major concern. Developing new chemical processes for pharmaceutical manufacturing can be expensive. In the first place, the industry must invest in research and development, equipment, facilities, and skilled personnel. The cost of scaling up a process from the laboratory to commercial production can also be significant.

Developing efficient and high-yield chemical processes is essential in order to optimize production and minimize costs. Pharmaceutical companies aim to maximize the yield of the desired product while minimizing waste and by-products. This requires expertise in process optimization, reaction engineering, and separation techniques.

New chemical processes involve intellectual property considerations. Pharmaceutical companies invest significant resources in research and development, so protecting their proprietary knowledge and innovations is crucial. They must navigate patent laws and ensure that their processes remain confidential and secure.

Last but certainly not least is environmental impact. Sustainability and reducing the environmental footprint of pharmaceutical manufacturing is gaining increasing importance. There’s growing demand to develop chemical processes that minimize waste generation, energy consumption, and the use of hazardous materials. Companies need to explore greener alternatives and adopt environmentally friendly practices.

Addressing these challenges requires a multidisciplinary approach, involving chemists, engineers, regulatory experts, and other professionals to overcome technical, regulatory, and operational hurdles. Collaboration between industry and academia can also play a vital role in tackling these challenges and advancing the field of pharmaceutical process development.

Q: How is your team overcoming these challenges?

A: Neuland’s vast technical and scientific expertise in route scouting is helping our partners identify the best, most feasible and cost-effective routes of synthesis for the API they want to manufacture. We bring strong experience in supply chain management to the process, which helps identify the best options for potential vendors. Our dedicated analytical team enables feasibility studies to be completed very quickly.

The advantages of strong technical expertise, seamless coordination between cross-functional teams, along with the quality policies adopted by our management have established Neuland as one of the best API/CMS manufacturers in the world.

Contact us today to discuss your next scale optimization or route scouting project.