Technology transfer is a critical aspect of moving a biologic from discovery to commercial manufacturing. Ideally, there is a clear plan for technology transfer that results in a successful final process. However, most have experienced situations where the transfer of processes causes significant bottlenecks. These bottlenecks can happen when technology is transferred from client to partner as well as the transfer of the final process from partner back to client. It can also happen internally when technology is transferred between company departments.
To achieve a successful technology transfer, both parties must commit to creating a detailed plan that will anticipate potential issues and provide a clear direction for exchange of information and ongoing communication. While there is always a desire to move as quickly as possible, the time and effort spent mapping out the logistics for technology transfer can save significant time and resources in the long run. Planning should include all process areas including identification of raw materials, equipment sourcing, resource availability and ongoing delivery schedules. There should also be a designated team with members from both the partner and client with routine communication and a planned training schedule.
A recent article, Navigating Technology Transfer, published in BioProcess International, features an interview with two senior bioreactor applications scientists at Pall Biotech, Marie-Laure Collignon, PhD and Shahin Heshmatifar, MSc, PhD, AMIChemE, FHEA. They explain and provide real examples of how they approach technology transfer and work with end users to create a successful outcome.
Key takeaways include:
Having the appropriate support is a key part of successful technology transfer. This means that teams must have members that can provide specific knowledge that is needed to further the process. For example teams within Pall Biotech Scientific and Laboratory Services specialize and offer support for operations in cell culture/upstream production, downstream purification, and formulation and filling (of both drug substance and drug product). This extends to providing knowledge relating to process validation and the regulatory landscape.
Knowledge Transfer for Custom Solutions
In order to provide a custom solution, knowledge transfer is a critical part of technology transfer. Pall achieves this by starting with a specialized questionnaire to capture the core goals of a project and serve as a framework for early discussions. Initial meetings use the provided information to review a process and define short- and long-term goals. Once clarified, the project progresses quickly to a detailed experimental plan, with each process customized to accommodate the goals and deadlines of the client.
Case Study using Single-Use Bioreactors
In the article, Pall Biotech specialists describe each step of a technology transfer process using their Allegro stirred-tank single-use bioreactors. They describe how they design a customized experimental plan using the detailed questionnaire to gather critical engineering parameters relating to the existing process. They then take this information and use it to create a set of operating parameters for an Allegro bioreactor system. They combine this with primary characterization data for the bioreactors to determine which controls are needed to create equivalent culture conditions at small and large scales.
Pall has amassed a great deal of characterization data for the Allegro stirred-tank bioreactors that provide a foundation of empirical data regarding temperature mapping, mass transfer (kLa), mixing times, and CO2 stripping to define the performance of these cubical biocontainers. In addition, they employ computational fluid dynamics (CFD) simulations that help create simplified, user-friendly models. This maximizes the likelihood of success and de-risks development.
The specialists describe another benefit of using the Allegro STR family of bioreactors is their predictable scalability. The bioreactors are available in 50-L, 200-L, 500-L, 1,000-L, and 2,000-L designs and they all share the same aspect ratio and the same impeller and sparger design. So when a constant power input and gas hold-up per unit volume is maintained and system control loops are used to maintain a target dissolved oxygen (DO) level, the Allegro STR system will provide the same performance at any scale.
Lastly the specialists describe how the relationships created during technology transfer provide a lasting impact. Application specialists naturally remain engaged with developments and available to provide ongoing consultancy, guidance, and support whenever needed. “When confidentiality allows, the team’s open-minded, collaborative approach makes us happy to explore opportunities for working together and publishing jointly. Sharing knowledge is the core of what our specialists do.”
To read the article in full, please see – Navigating Technology Transfer
For more information, email firstname.lastname@example.org. Allegro is a trademark, and Accelerator is a service mark of Pall Biotech.