A  top priority for drug developers is to find outsourcing partners with experience in transferring and scaling their product formulation and processes from sending unit (SU) to commercial-scale receiving unit (RU) in compliance with regulatory agencies.

A successful manufacturing technology transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and range of regulatory filings required.

Whether you are a drug developer searching for a CDMO partner for the first time, rising to a new role, or a veteran scrambling to fill a gap in your supply chain, there are four key considerations for gauging strong technology transfer performance: geographic footprint, technology, regulatory compliance, and talent.

1. Geographic footprint

An understanding of the market landscape requires more than securing global market manufacturing capacity -- that is just a tactical consideration. Your manufacturing partner should understand the terrain of your campaign and the landscape of your entire drug marketing strategy including:

      - Understanding of applicable regulatory filings in your market  
      - Operations that are compliant with applicable regulations 
      - Scale, flexibility and reach to meet the needs of global markets
      - Supply chain integrity along the entire development path
      - Data security and integrity  

Key principles for a geographic footprint

• Take time to thoroughly understand the regulatory environment that you are targeting when you plan and strategize a tech transfer. A site will need to release product in compliance with the regulatory standards of the applicable market.
• Research the import and export regulations that you will face in a market.  
• Be mindful of cultural differences between markets.  

2. Technology 

Technology goes beyond having the latest spray-dryer or bioreactor. What your potential partner can do with that equipment is what counts the most. Review your partner’s technical transfer performance against its ability to:

      - Recognize economies of scale with safety and sustainability in mind
      - Deliver robust, reliable, and validated processing capabilities

Key principles for technology

•  Conduct a deep dive to understand the factors that may affect the technology transfer including a gap assessment and risk assessment to ensure that it will be successful the first time.
• Ensure that you understand the robustness of the drug product and its sensitivities.
• Involve all relevant functions in the technology transfer, not just the technical team. This would include Supply Chain, Regulatory, Quality and Environmental, Health and Safety teams.

3. Regulatory compliance

Evaluate partner potential by understanding [a CDMO’s ability to proactively maintain regulatory compliance. Consider these key indicators:

      - Dossier requirements and the ability to harmonize components for use in multiple markets
      - Solid cGMP manufacturing operations and a demonstrated history of continuous improvement
      - Documentation and filing data management and integrity
      - Regulatory responsiveness and filing efficiency
      - Relationships with and understanding of regulatory bodies

Key principles for compliance

Establish and document your regulatory strategy first

• Consider regulatory impact to the market(s) when deciding if any changes can be made during the tech transfer process. For example, changing of suppliers for one or more raw materials. This is particularly important when a tech transfer is done for an already commercialized product.
• Be mindful of the product stage as this will affect the regulatory compliance requirements
• Be aware of the maturity of the product on the market; if you are transferring a product that has been on the market for the past 20 years, the dossier should be assessed to determine whether there are any documentation gaps that may need to be addressed before a new site can be added to the regulatory application

4. The right people 

Managing successful technology transfers between organizations requires talented people with proficient project management and operational skills combined with scientific expertise. Look for external partners with both the talent and skill to:

      - Master timelines and regularly communicate about project milestones  
      - Avoid pitfalls by identifying risks early on and establishing comprehensive mitigation plans that can be triggered if technical or regulatory concerns become a reality
      - Demonstrate transparency and confidence by showing the technology transfer protocol which documents the transfer  
      - Understand the requirements of different markets to support a successful addition of a new site to an approved regulatory application.
      - Manage program resources and project finances effectively
      - Achieve program milestones across various disciplines

Key principles for the right people 

• Clearly outline and align roles and responsibilities between the SU and RU
• Emphasize the importance of project management skills as well as technical skills as a large volume of the work is management-led and, without these skills, a successful tech transfer could potentially be at risk.

Focus on technology transfer for better outcomes

No matter what your strategy is, the success of any program is likely to be prefaced by a robust, efficient, and smooth technology transfer. Evaluate the potential of prospective CDMO partners on their technology transfer performance parameters such as on-time execution of registration batches and their ability to ensure a positive result for the addition of a new site to your regulatory application. Most importantly, remember these four key considerations for better outcomes – geographic footprint, technology, regulatory compliance, and talent.

For more information on Pfizer CentreOne’s technology transfer expertise for your project, contact us here.