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36 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2023 PharmTech.com INTERPHEX RouNduP Bornholdt: In the pharmaceutical world, everything is about protecting the patients, which means protecting the product. In my presentation [at INTERPHEX], I spoke a little bit about the intersection of three different trends that we have been seeing grow: process closure, the move towards modularization, and the move towards continuous manufacturing. Those three things are really helping us protect products and protect patients. Getting the operators outside of cleanrooms where products are being made is really the pivotal underpin- ning. We've seen a very pronounced progression of that, especially over the past 10 years, and over the past five years with cell and gene therapy racing to separate that product from the environment that it's made in. PharmTech: Where do you think bio/pharma manu- facturing will be 10 years from now? Bornholdt: I would say a bold prediction looks like completely rethinking the way that manufacturing occurs, and even what manufacturing is. For example, we're used to seeing these very large, centralized manu- facturing facilities in just a few places around the world. With the advent of cell and gene therapies, and also with the pandemic response, there is definitely a trend to- wards scaling processes down and then spreading them out in a distributed manner for closer access to patient populations to those lifesaving, critical drugs. So, I think we are going to see a lot more of manufacturing pieces of equipment that are spread more at the point-of-care, instead of the idea of one manufacturing plant. Medical devices Mariano Mattei, vice-president of cybersecurity and CISO for Azzur Group, hosted a presentation on FDA's draft guidance for cybersecurity in medical devices (4). In an interview with Pharmaceutical Technology® at IN- TERPHEX 2023, Mattei discussed the broad strokes of his presentation, which highlighted the fundamental changes brought about by this guidance and what needs to be done to get ahead of these changes. "The FDA would like to know that manufacturers are considering cybersecurity, from birth until death, in every phase of a medical device manufacturing process," said Mattei. "That includes post-market, that includes post-life—in essence, it means tracking which vulnera- bilities could potentially exist, which ones do we know about, what can we implement to mitigate these vulner- abilities, and then what is our residual risk." As an example, Mattei explained how malicious ac- tors were able to access a baby heart rate monitor and make it appear as if the infant is in distress. If hackers were able to get into more serious medical devices, like a pacemaker, this could lead to serious complications or even death. To increase security and get ahead of the changes in this guidance, Mattei suggested some fun- damentals companies should keep in mind. According to Mattei, three crucial things must be done: data at rest and in transit should be encrypted, good identity and access management—like multi-fac- tor authentication—should be implemented, and net- work segmentation should be enforced. He also stressed that developing a plan and documenting it is fundamen- tal to staying ahead of the guidance, as FDA wants to ensure that cybersecurity is being considered. "They want to make sure that you're documenting this, that you're considering the possibilities, and that you have mitigation policies in place," said Mattei. References 1. Blaschke, U.; Atouf, F.; Challis, P. mRNA Supplier-de- veloper Relationships and Technical Advances. Pre- sentation. INTERPHEX 2023, New York City, NY. 2. C. Spivey. Six Approaches Making the Most Signifi- cant Impact in the Future. Pharm. Technol. 2023 47 (1). 3. Nahmias, Y.; Trietsch, B.; Bentwich, I. Organ on a Chip for Pharmaceutical Development. Keynote Presenta- tion. INTERPHEX 2023. New York City, NY. 4. Carroll, D and Smith, T. Automated PAT-Driven TFF System Using In-Line Concentration Monitoring to Control the UF/DF Process. Poster. INTERPHEX 2023. New York, NY. 5. Mattei, M.A. How to Prepare for the FDA Medical De- vice Cybersecurity Guidelines. Presentation. INTER- PHEX 2023, New York City, NY.■ For more on this interview, please scan! For more on this interview, please scan! Adare Pharma Solutions ....................................................................................3 Ascendia Pharmaceuticals ..............................................................................15 Baxter Healthcare Corporation .......................................................................13 BioVectra DCL ...................................................................................................25 Coating Place, Incorporated ..............................................................................7 Colbert Packaging .............................................................................................21 Diosna Dierks & Sohne GmbH .........................................................................37 Jubilant HollisterStier Contract Manufacturing ............................................. 33 Kindeva ............................................................................................................. 29 Mikart .................................................................................................................27 Natoli Engineering Company, Inc. ...................................................................19 PDA (Parenteral Drug Association) ....................................................................9 Veltek Associates, Inc ........................................................................................5 Ad Index COMPANY PAGE