Trends, challenges and priorities
Markets are growing and the range of new product types is expanding. To prepare for these exciting opportunities, drug product and secondary packaging processes will need to develop excellent operations and quality management systems (QMS) and develop new capabilities. New markets continue to emerge for existing medicines that will require lean supply chains and more in-region manufacturing. New product types will include non-mAbs, cell and gene therapies, and more complex devices. Also, patients and clinicians are understandably demanding more convenient modes of delivery, such as longer-lasting formats and better electronic patient information.
The industry will need to invest to realize the opportunities, adding pressure on current CAPEX and OPEX costs. Another challenge, more acute in the Covid-19 world, is the uncertainties of inbound supply where there are shortages of quality, vital, raw materials, such as vials and single use systems (SUS).
In a competitive multi-opportunity market, it is essential fill finish does not impede speed to supply clinical trials and speed to supply the market. Industry’s relentless drive for quality is matched by the expectations from health authorities that continue to expect higher standards or quality, for example in demonstrating sterility assurance and product serialization. Of course, the industry must also contribute to environmental sustainability and reduce material waste generated by its operations and products.
The costs of quality and compliance are high. It is a complex and time-consuming task to minimise the risk of harm to patient, batch loss and challenges by inspectors. Even the most experienced companies face challenges in designing processes and using equipment which will meet ever more stringent regulatory requirements. Quality and demonstrating compliance will remain the priority of BioPhorum Fill Finish. To address these challenges, drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations are working relentlessly to continually improve the pharmaceutical quality system (PQS). BioPhorum Fill Finish has recently made progress in best practices in several key areas: sterile filtration quality risk management (SFQRM), environmental monitoring (EM), container closure integrity (CCI), visual inspection (VI) and isolator gloves management. The seminal work of the SFQRM consortium provides a risk-based approach to the sterilization of filters has been very well-received by industry and health agencies.
In these areas, major improvements with currently available technologies are also being evaluated and the barriers to adoption being cleared. For example, the Alternative and Rapid Micro Methods (ARMM) team is working to remove settle plates in grade A areas with direct-detection systems (i.e., bio-fluorescent particle counters (BFPCs) that can detect viable and non-viable particles in real-time). The Isolator of the Future team is developing best practices for automation that will reduce the need for human beings, which is the primary contamination risk. In 2022, the Phorum’s Visual Inspection team provided a user requirement specification for testing technologies and wrote a paper providing much needed clarity on misunderstandings about 100% testing.
The Phorum members are also wanting to create space to support each other with the implementation of Annex 1, a key driver for changes to filling operations.
An essential element to successfully meet challenges is the need for a single industry voice. The Phorum will utilize BioPhorum’s collaboration with the ASTM and USP and continues to form partnerships to add value for members, which include: the SFQRM consortium with the Parenteral Drug Association (PDA); the ARMM team’s partnership with thought leaders in the PEMM group and OWBA; and discussions with EDQM’s Expert Group 1 EDQM; the EM team and the team revising the PDA’s TR13; and the Phorum’s Robotic team coordination with the ISPE–DACH’s Robotics Special Interest Group. The Secondary Packaging team are also working with experts from GS1 on ePI (electronic patient information). The Lyophilization team in 2022 partnered with the University of Purdue’s Advanced Lyophilization Technology Hub to work on a paper on technology transfer best practices with case studies.
In 2022 a set of manufacturing scenarios were defined by our members, that are required to address the opportunities and challenges mentioned above. The emerging goals are shown in the figure below. In the final months of 2022, we are developing a plan to work collaboratively towards a future set of priorities. Including an ambitious workstream accelerate progress towards commercial lines of the future.
Demand for FF capacity exceeds supply, and there is demand for new more complex to make product types and flexible manufacturing. FF capacity is expensive and takes time to build. So, our work on commercial facilities of the future will accelerate availability of next generation filling and process control technology and make it simpler for members to make smart CapEx choices. Here, BioPhorum FF is also leveraging supplier expertise in the Technology Roadmap and Supply Partner Phorums.
Many of the Phorum members depend greatly for fill finish capacity on contract manufacturing companies. While several contract manufacturers are valued members of the Phorum, we continue to encourage non-members to collaborate and keep pace with views on best practices; in turn contract manufacturers could connect with their clients to eliminate variation in practices which add no value. Potential topics for collaboration include tech transfer and deviation management.
The Phorum’s ethos is very much about declaring success only when best practices are implemented. All workstreams are chartered to both deliver best practices and provide stewardship and support for wide-scale implementation. Perhaps the most important feature of the Phorums is that the work is done in positive atmosphere in which problems are discussed openly, advice shared generously. Subject matter experts find-like minded scientists and engineers to work with and learn from. Our professional facilitation is about creating this vibe of mutual trust and joy in developing robust solutions to tough problems together.
Fill Finish deliverables June 2022 to June 20232
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