December 8, 2021
One silver lining to the cloud of meeting only virtually has been our ability to “attend” some conferences to which we’ve not made it very often in the past. For example, I enjoyed tuning into the International Society of Pharmaceutical Engineers (ISPE) 30th Annual Aseptic Processing Conference, which was held virtually this past spring. It helped me plan for our September featured report, and it provided a good general update on the current state of biopharmaceutical formulation, fill and finish. You’ll find the conclusion of a two-part article on page 50 of this issue that is adapted from a presentation given at this meeting.
Richard Friedman (deputy director of science and regulatory policy at US FDA CDER’s office of manufacturing quality) and Jean Hu Primmer (global regulatory lead at GSK Vaccines) were ISPE’s keynote speakers. Friedman highlighted risk reduction, reliability, and sustainability as drivers for modernization of sterile drug manufacturing. Primmer reported on how public–private partnerships can assist in addressing infectious diseases. In a panel session later in the program, other regulatory representatives discussed pandemic effects on the industry. Prominent topics on the meeting agenda were familiar to BPI readers: advanced therapies, automation, contamination control and facility considerations, operator safety, pandemic response, regulatory developments, and single-use technologies. And it wasn’t surprising to find those topics overlapping quite a bit.
Jörg Zimmermann (vice president of external affairs for Vetter Development Service) chaired the conference this year. “In terms of value,” he pointed out, looking to the near future, “sterile dosage forms will overtake all others.” Most new drugs now in development are injectables that need to be formulated and filled in sterile surroundings.
Highly potent compounds and advanced-therapy medicinal products (ATMPs) are challenging the industry to rethink aseptic processing. Because they do not allow for the use of sterile filtration or terminal sterilization, ATMPs require aseptic processing throughout the whole process that goes on between apheresis and (re)infusion. Cell therapies blur the line between drug-substance and drug-product manufacturing — in some cases leading to a batch size of one unit. Automation should provide the solution to producing small, personalized batches at the necessary scales. Robots now perform tasks in fill–finish that had to be manual just a few years ago. As one presenter put it, “What can be automated will be automated” whether to protect operators, products, or both. “The technology is there, and it is getting cheaper and simpler to apply every day.”
As technologies evolve, so too do regulations. The European Union’s Annex 1 underwent an important comment period in 2020, sparking debate throughout the industry around the globe. Both the World Health Organization (WHO) and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) were heavily involved. The latter recently revised its own Annex 2A document on ATMP quality, and an Australian representative who worked on that project reported at this conference on his working group’s experience. Contamination control featured heavily in that work — and in discussions in the breakout sessions.
The topic of another article in this issue (page 12) was presented at the conference as well: BPI editorial advisor Bill Whitford presented with Magali Barbaroux on proper cleaning, disposal, and handling of single-use technologies. Vaccines and industry 4.0 figured into the discussion, which primarily revolved around the “six Rs”: rethink, reduce, reengineer, reuse, recycle, and recover energy. The Bio-Process Systems Alliance (BPSA) has made a strong case that disposable systems and components provide cost, health, and safety benefits while contributing a very small fraction of overall plastic waste. Even so, suppliers, engineers, architects, and biomanufacturers seek to reduce the environmental burdens of single-use technologies further as they all work toward the concept of a circular plastics economy.
Part of due diligence in making implementation decisions is considering the real costs: capital, maintenance and support, cleaning and disposal, and overall life-cycle costs. Companies need to balance the benefits and drawbacks of a technology. Many organizations are finding that single use is best for small batches whereas stainless steel remains the choice for large drug-product manufacturing. And pandemic-related supply chain interruptions are highlighting the danger of depending too much on component suppliers for everyday operations. Maybe “just-in-time” inventory isn’t all it’s cracked up to be. Planners need to take all these issues into account as they consider both environmental responsibility and cost considerations.
Robust and safe processes form the foundation of biopharmaceutical manufacturing. Changes are inevitable as technologies advance, but making even small alterations can increase overall risk. New equipment, changes in raw materials, and transfers of production to other sites have to be managed properly. We find that quality by design (QbD) and quality risk management (QRM) principles now figure into just about every aspect of biologics research, development, and manufacturing — especially when it comes to making choices in navigating the road to market.
As BPI moves into its 20th year of publication — and yes, we’ll be celebrating that achievement all year in 2022 — we intend to strengthen our position as your go-to publication for decision-making support. We’re looking forward to renewing our relationships with Phacilitate (which will be known as “Advanced Therapies Week” from now on), Interphex, and the Biotechnology Innovation Organization’s annual convention. We will introduce a new awards program to which we think you’ll want to contribute your thoughts: Where are the best places to work in biotechnology, and which biopharmaceutical companies deserve to be lauded for their accomplishments and forward focus? The BPI readers’ choice awards will see a refreshing new approach. Our Informa Connect colleagues will introduce several new ways for us all to interact. And of course, there will be the usual eBooks, webinars, featured reports, and regular issue themes you’ve come to expect from us every year.
The realities of COVID-19 have forced many people to reconsider a lot of things we used to take for granted, and we’re looking forward to seeing what that will mean to our readers, contributors, and the industry we cover in a postpandemic world.
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