From Lab to Market: Essential Strategies to Assist with Biotech Scale-Up Success

Transitioning from early development to late-stage manufacturing and commercialization of therapeutics can present numerous challenges for new and emerging biotech companies. The processes and regulations in research and discovery (R&D) settings can differ significantly from those in large-scale Good Manufacturing Practices (GMP) environments. A smooth transition between different stages can help prevent any project and timeline delays.

Understanding the transition from R&D to large-scale production

The shift from R&D to large-scale production involves a change in mindset and approach. Commonly, in research settings, processes are often small-scale, exploratory, and flexible, allowing for creativity and rapid development, but often lacking strict structure and oversight.  By contrast, larger scale production environments require stringent adherence to regulatory standards and quality control measures to support the consistency, safety, and efficacy of the final product. This transition requires a comprehensive understanding of GMP regulations, robust documentation practices, and a focus on reproducibility and consistency.

What are the key challenges in scaling up production?

There are several common challenges that new biotech companies usually face during scale-up. Addressing them early and adequately can help ensure a successful transition from an R&D setting to large-scale manufacturing. Let’s look at them in more detail:

• Regulatory compliance: Navigating the complex regulatory landscape is one of the most significant bottlenecks in scaling up production. Maintaining compliance with pharmaceutical regulations involves extensive documentation, quality management systems, and adherence to Standard Operating Procedures (SOPs). This rigorous approach is also essential to help to maintain the integrity and reliability of the production process.
  
• Process and equipment validation: There are several critical steps, including conducting Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and performance qualifications. These steps can be time-consuming and require meticulous attention to detail to support both regulatory compliance and product consistency.
  
• Facility design and cleanroom standards: Designing facilities that meet GMP standards involves careful consideration of cleanroom classifications, air quality, and contamination control. The design must facilitate efficient workflows while minimizing the risk of cross-contamination. Discover our virtual facility design tool to explore possibilities.
  
• Quality control (QC): Implementing robust quality control measures is essential to maintaining the safety and efficacy of the final product. This involves validating quality control methods, maintaining independent QC labs, and ensuring data integrity through rigorous documentation practices.

Common strategies for effective production scaling

Effective scaling in bioprocessing requires a multifaceted approach, wherein several strategies can significantly improve efficiency and accelerate the scaling efforts. Those strategies include:

• Early-stage scalability: Consider scalability from the early stages of process development. Choose cell lines, media, and equipment that are amenable to scaling. Utilize small-scale systems that mimic large-scale conditions to help optimize processes before scaling up.
  
• Collaboration and expertise: Leverage the expertise of consultants, suppliers, and industry peers. Collaborate with experienced professionals who can provide insights into regulatory compliance, facility design, and process optimization.
  
• Single-use technologies: Utilize single-use equipment to help reduce the risk of contamination and to help streamline processes. Single-use systems are particularly beneficial in multi-product facilities, allowing for quick changeovers and enabling reduced cleaning and validation requirements.
  
• Risk management: Implement risk management strategies including Chemistry, Manufacturing, and Controls (CMC) designed to identify and mitigate potential sources of contamination. Conduct thorough risk assessments and establish protocols to control and monitor critical process parameters.
  
• Process Analytical Technology (PAT): Employ PAT to help improve process efficiency and control by defining Critical Process Parameters (CPP) and monitoring these CPPs in-line or on-line to maintain a product’s Critical Quality Attributes (CQA).

Conclusions

Scaling from R&D stage to large-scale production requires careful planning, adherence to regulatory standards, and a focus on quality control. By considering scalability early on, leveraging expert collaborations, and implementing robust risk management strategies, biotech companies can navigate the complexities of this transition and achieve successful commercialization of their novel therapies.

Related resources

• Watch our webinar on Scaling from Research to Production for Biotech Success
• Learn how Thermo Fisher Scientific can support new and emerging biotech companies
• Read whitepaper on top bioproduction considerations when scaling up
• Design your own clean room virtually 
• Learn about our regulatory support