Technology transfer.
The technology-transfer process was initiated by creating a comparability document that detailed every aspect of the manufacturing
process. The process used in the European manufacture was listed step by step in the document with Catalent's suggestions
and capabilities side by side. A final agreement for each step was included and served as the approved path forward. The specifications
for in-process testing at each stage of the formulation as well as finished-product specifications were included in the document.
The formulation process required bulk sterilization of a multicomponent polymer base with a relatively tight viscosity range.
Two APIs were combined in a second part of the formulation and transferred to the polymer solution by sterile filtration.
Of course, the entire formulation skid required steam sterilization of the product path through the BFS machine and maintenance
of the sterile boundaries for the product during the entire filling process. Electronic documentation of all temperatures,
times, and controls for each process step also were also required.
Communication.
The NPD project manager and the strategic account manager facilitated weekly calls with the original equipment manufacturers
of the formulation and BFS equipment as well as construction meetings during that phase of the project. Weekly calls were
held with the customer representatives who were in liaison with the project team. A standard methodology was used to ensure
that the meetings had a structured agenda and minutes issued for review in a timely fashion. A joint Project Steering Committee
was formed, which was comprised of customer senior leadership members, Woodstock site leadership members, and Catalent business-development
members.
Figure 1 (Catalent): A blow/fill/seal suite at Catalent’s Woodstock, Illinois, facility. (FIGURES 1-3 (CATALENT) ARE COURTESY
OF THE AUTHOR)
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Project Steering Committee meetings were held every three weeks during the course of the project. A formal presentation was
made at each meeting to discuss progress toward major milestones in the project plan. Strategic decisions were discussed and
developed through the Project Steering Committee meetings, and the decisions were ultimately made by the joint project team.
This management design reduced the cycle time for critical decision-making between the customer and Catalent.
An example of such decision making was approval of a change to the SAT/FAT strategy originally planned for the formulation
skid. The formulation skid is a fully automated two-tank system with over 100 control and process valves that are actuated
in approximately 20 sequences. When the software development lagged behind the construction of the hardware, the opportunity
arose to do a mechanical FAT, ship the formulation skid to the Woodstock site, complete the installation and mechanical troubleshooting
of the skid and wait for the software to complete the qualification as a SAT. This decision saved as much as six weeks in
the project schedule and enabled Catalent to meet the customer's timeline for stability and process-validation manufacturing.
It also resulted in a formulation system that is part of a robust technical transfer process from the customer through the
NPD group to Catalent's commercial manufacturing team.
Execution.
To date, all of the engineering, stability, and process-validation batches have met the in-process and final-product test
specifications. With nine batches produced, there have been no out-of-specification results for bulk or final product. In
addition, no human error deviations have occurred in the formulation and filling of these batches.
Figure 2 (Catalent): A blow/fill/seal cavity fill machine at Catalent’s Woodstock, Illinois, facility.
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Figures 1–3 (Catalent) show the facility upgrade and project equipment after installation.
Figure 3 (Catalent): A fully automated formulation skid at Catalent’s Woodstock, Illinois, facility.
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In summary, Catalent did not employ new or groundbreaking methodology for this project. However, supplying the proper structure
and resources for a project team is the crucial first step in meeting a customer's timeline and supplying the customer with
quality product, reliably supplied.
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