Why process development matters: Six benefits for biotech and pharma companies

What is process development?

Process development involves creating and improving manufacturing methods to make drug production efficient, cost-effective, and compliant with regulations while maintaining high product quality. It transforms a drug from an early concept into a mass-produced product by ensuring each step is efficient, scalable, and reliable. This includes selecting raw materials and production equipment, optimizing processes, and developing quality control methods to ensure that the final products are consistently produced at scale.

“Process development ensures that drugs are produced efficiently, safely, and at high quality, meeting regulatory standards and patient needs.”

Why is process development important?

Process development ensures that drugs are produced efficiently, safely, and at high quality, meeting regulatory standards and patient needs. Additionally, process development can help ensure that the drug's active pharmaceutical ingredient (API) is effectively incorporated into the final product formulation, optimizing both efficacy and manufacturability. By investing in efficient process development upfront, biotech and pharma companies can reduce production costs and speed up time-to-market, providing a competitive edge in a high-stakes industry. 

Six key benefits of effective process development

- Improve quality and consistency

Process development improves the quality and consistency of pharmaceutical products by carefully designing and refining each step in the manufacturing process. Detailed testing and optimization ensure that each stage operates within exact parameters, minimizing variability and preventing issues that could affect the final product. This thorough approach ensures that each dose is consistent, ultimately building trust in the product and supporting better patient outcomes.

- Optimize efficiency and cost-effectiveness

By analyzing each step, process development can identify and address bottlenecks early on, eliminate inefficiencies, and apply best practices to boost productivity. This includes optimizing raw material usage, reducing waste, and improving yields, all of which help lower production costs. Effective process development reduces the need for costly rework and minimizes delays, leading to a smoother, more reliable manufacturing process. These improvements save money and accelerate time-to-market, getting drugs into patients’ hands faster.

- Enhance product quality and scalability

By optimizing processes from the start, developers ensure that methods can be scaled up efficiently without compromising quality or consistency. This includes testing and validating to address challenges like batch size variations, equipment performance, and material handling. These activities result in a robust process that can handle potential challenges and maintain efficiency and consistency in production. Scalability is crucial for maintaining a steady supply of high-quality products and supporting commercial needs.

- Support regulatory compliance

Through careful planning, documentation, and validation, process development creates reproducible manufacturing protocols that meet regulatory requirements from bodies like the FDA and EMA. This involves implementing Good Manufacturing Practices (GMP), considering Quality by Design (QbD) principles, conducting rigorous quality checks, and keeping detailed records. Integrating compliance from the start helps demonstrate product safety, efficacy, and quality, smoothing the path to regulatory approval in both regional and global markets.

“Starting process development early on is crucial for building a solid foundation for scalable and reliable manufacturing.”

- Advance risk mitigation

Process development manages risks by identifying and addressing issues early on, before they lead to higher costs and longer timelines. Proactive planning allows drug developers to tackle problems related to scalability, quality, and consistency before they escalate. This involves risks related to raw materials, reagents, equipment, and variations, as well as putting adequate controls in place. Establishing contingency plans helps prevent batch failures and regulatory issues and protects product quality, patient safety, and the company’s reputation.

- Pave way for innovation

By fine-tuning production methods through process development, biotech and pharma teams can explore and adopt practices that may improve efficiency and quality. For example, incorporating automation and digital tools can reduce manual work, leading to more precise and reliable results. Strong process development nurtures an environment of innovation, pushing the boundaries of what’s possible in drug development.

The value of early process development

Starting process development early on is crucial for building a solid foundation for scalable and reliable manufacturing. By focusing on process development from the outset, companies can identify and refine parameters while the drug’s critical quality attributes (CQAs) are still being defined. This proactive approach helps avoid major roadblocks, saving time and resources on the path to approval. Early process development also ensures a smoother transition from small-scale lab production to large-scale manufacturing, aiding in timely regulatory approvals and market entry. Integrating process development early enhances efficiency, improves consistent product quality, and increases the chances of successful commercialization.

How a CDMO can help with process development

A contract development and manufacturing organization (CDMO) like Thermo Fisher Scientific can assist biotech and pharma companies with process development. They offer specialized expertise, advanced technology, and comprehensive services and solutions throughout the drug development lifecycle. This support helps optimize manufacturing processes, ensure scalability, and meet regulatory requirements. For companies lacking in-house capabilities, CDMOs provide valuable assistance from early-stage design to scale-up and commercial production. Partnering with a CDMO allows drug developers to focus on their core competencies, speed up timelines, lower costs, and reduce risks, smoothing the journey from molecule to medicine to market.