Pharmaceutical Manufacturing editors recently attended the 2017 Parenteral Drug Association Annual Meeting in Anaheim, California. The numerous presentations provided insight into what the industry is doing now and what they should be doing in the future, while staying grounded in the underlying reason of why the industry is here to begin with - the end goal of safe, effective, life-saving products. Suleika Jaouad, cancer survivor and New York Times columnist, set the tone in the opening plenary session by saying, “Please don’t give up on pushing for new and more effective cures. Don’t stop traveling where the silence is. Your work has the potential to affect real lives and real people.”
The FDA is continually pushing the pharma industry as a whole toward the desired state of quality: a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight. Not surprisingly, one major theme resonating throughout the PDA Meeting presentations and exhibit hall was the growing need for flexibility. Facing an increased focus on reducing costs and less predictability of the future demands for products, the industry needs more flexible and agile facilities.
Production site design and process equipment flexibility is rapidly becoming the primary characteristic of a next generation biologics manufacturing facility. Gone are the days of large capex investments into rigid production facilities that cannot be scaled for varying production demands or adjusted for varying products. As Mike Vandiver, vice president, Manufacturing & Plant Design, Just Biotherapeutics, aptly pointed out in his presentation on Next Generation Biomanufacturing, “technology will inevitably change, so we need to design facilities that can accommodate these changes.”
Flexible facilities will also enable another growing trend - that of personalized medicines. The market has begun to shift toward a stronger focus on smaller patient groups, rare diseases and orphan drugs. As efficacies of therapies continue to rise, these efficacies are driving demand for personalized medicine.
Henriette Schubert & Mikkel Mohr Madsen of pharma engineering consultancy, NNE, tackled the idea of personalized medicine as a disruptive innovation in pharma, discussing the potential of the “batch of one.” The paradigm shift towards a batch of one would mean patient-specific therapies: one batch = one patient.
This increased focus on smaller populations does, however, make recovering costs even more challenging for manufacturers, mentioned Barry Starkman, principal consultant at DPS Engineering, during his presentation. These patient-based therapies utilize a high standard of aseptic processing and require rapid release possibilities to ship the injectable to the patient. Smaller batch sizes reinforce the need for rapid turnaround - rapid cleanup, setup, and line clearance, said Starkman.
Many drugmakers are recognizing that emerging technologies - any innovative or novel product, manufacturing process or analytical technology — present an opportunity to create a paradigm shift in drug manufacturing. This greater willingness to try emerging technologies by both drug manufacturers and regulators is helping ease the industry’s burdens as it adapts to a changing landscape. Many barriers traditionally faced by the pharmaceutical industry, such as the industry’s innate conservatism and perceived regulatory hurdles, are lifting, opening the door to technology. A few emerging technologies that were discussed at the meeting include: improvements in isolator technology, even gloveless isolators; the digital design of the manufacturing process for innovative medicines; advances in 3D printing; and continuous manufacturing.
The FDA has created the Emerging Technologies Team specifically to address industry concerns regarding the FDA being a roadblock for new technology. The ETT will serve as a centralized location for external inquiries on novel technologies, providing a forum for firms to engage in early dialog with the agency to support innovation. During her PDA presentation, Laurie Graham, acting director, DIPAP, OPPQ, OPQ, stressed that CDER sees emerging technologies as a critical part of achieving vision for the future. The agency is reinforcing its commitment to facilitating the development and implementation of these technologies, looking for feedback and engagement from industry, offering face-to-face meetings and plant visits in order to discuss the use of emerging technologies in the manufacturing process.
Certainly the future of sterile and biopharmaceutical science holds much promise, as evidenced by the novel approaches for development and commercialization of pharma and biopharma products discussed during PDA’s flagship meeting. Innovative technologies and evolving mindsets are paving the way for a more flexible, personalized future of medicine.
In PDA news, two important developments were discussed at the Annual Meeting. First, PDA is now an ANSI Accredited Standards Developer (ASD). PDA was approved by ANSI to be an ASD because PDA’s portfolio of technical reports, which has grown to nearly 80 active documents, includes a number of topics, such as aseptic processing, microbiology and drug/device packaging, that are ideal candidates to become American National Standards. Additionally, PDA discussed the continued efforts of the association’s Manufacturing Science and Operations Program, which will highlight the ways in which pharma manufacturers can benefit from PDA work, specifically by identifying and encouraging the use of new manufacturing technologies and methods.
“What seemed unrealistic only 10 years ago now seems to become reality within the foreseeable future,” concluded Henriette Schubert.
