Jim Nadlonek, Director, Aseptic Processing Technologies, IPS-Integrated Project Services, LLC
A: In 2018, robotics will have the largest impact in the industry, where we’ll see high-speed lines incorporate robotics to eliminate gloves in the isolator. For any isolator, the biggest challenge today remains the gloves. Large traditional isolators with multiple lyophilizers can have up to 40-50 gloves. The cost to replace gloves, the time it takes to test their integrity (whether this is visual or automated), along with the time-consuming microbial monitoring process, greatly impact the isolator turnaround time and are highly scrutinized by the quality and regulatory bodies focusing on the handling of the gloves. With a gloveless isolator, all of these issues go away.
The challenge to this is how you replace the function of “hands” in the isolator. Here’s where the use of master-slave robotic arms comes into play. Robots will replace the environmental monitoring program inside the isolator. The automatic decontamination cycles within an isolator are certainly better than manual sanitization. These decontamination cycles are also very close to sterilizing all of the surfaces. One has to ask, as we approach sterilization within the isolator, can we also achieve parametric release? Hypothetically, one could equate it to filling inside an autoclave after a sterilization cycle.
Elliott Berger, Vice President of Global Marketing and Strategy, Catalent Pharma Solutions
A: Pharma companies are increasingly looking for improved delivery technologies that have the ability to deliver difficult molecules in a more patient-friendly way, and it is anticipated that this trend will continue.
Intelligent formulation and dose design will be even more critical earlier in the drug development process. For example, we consider that the demand for noninvasive delivery of biologics should continue to make progress. Oral delivery of peptides through technologies such as Catalent’s patented OptiGel™ BIO and Zydis® BIO technologies are advancing, as well as other technologies, including micro-needle arrays. Demand for treatments that patients can self-administer will also pick up speed, for example,
with auto-injectors and [e-enabled] inhalers.
Marga Viñes, Business Development Manager, Contract Manufacturing, Grifols
A: Over the next coming years, parenteral packaging will experience significant changes, with a high demand for ready-to-use containers (premixed) in-front admixtures. The main and most important concern for premixed bags is the integrity of the drug, and how to avoid any kind of interaction between plastic and drug. Technologies required to manufacture premixed bags are focused on the efficiency of filling/closing operations, high-quality requirements, fully automated fill/finish process and particles control.
Dr. Lorenz Mayr, Chief Technology Officer, GE Healthcare Lifesciences
A: Among the many technologies currently showing up on the horizon, we expect that we will see advances in the following three technologies — which are going to have the biggest impact for 2018 and beyond:
a) 3D Bioprinting
b) Digital Health
c) Drug Delivery
Constant improvement in technologies, devices and applications for 3D printing of biocompatible materials and biological samples will enable novel applications in Pharma R&D and human therapy. We predict a huge amount of innovation in that space with the development of novel additive manufacturing technologies and novel biocompatible materials. The generation of multicellular in-vitro systems and eventually even multicellular in-vivo systems/organs will enable novel applications for drug testing and therapeutic use, eventually even tissue repair in humans.
We predict that significant progress will be made by merging advances in the development of novel instruments, including wearable devices and novel biosensors, with the development of novel software tools/applications for data monitoring, data transfer and data analysis. We expect that the field of digital health will continue to impact all areas of pharma, from R&D to manufacturing, distribution and sales, clinical diagnostics and, ultimately, to novel applications for clinical use in humans. We predict that further advances in delivery technologies for chemical and biological molecules will enable novel applications in humans, animals and plants. This will accelerate further the use of novel therapeutic agents, such as ASO and modRNA, complex chemical molecules, novel biological molecules and formats and various combinations thereof.
Professor Tom Moody, Ph.D., VP Technology and Commercialization, Almac Sciences & Arran Chemical Company
A: We anticipate that enzyme technology will continue to develop rapidly. “Green” chemistry is very much at the forefront of minds within the chemical industry, and utilizing enzyme technology is becoming the norm rather than the exception. To this end, we are extending our selectAZymeTM platform to include over 4,000 unique enzymes from diverse biological sources, which will be ready for immediate implementation at kilogram to tonne scale. We know what our clients need, and how to deliver successfully using the most innovative techniques.
Within Arran Chemical Company (acquired by Almac in 2015), we have completed the first phase of our “ADAPT” strategy. ADAPT (Arran Deploys Advanced Production Technologies) takes innovative enzyme technologies, which would traditionally require significant process development effort prior to deployment, to an optimized state where they can be quickly implemented in routine production, thereby meeting the challenging supply chain timeline requirements of pharma clients. Future growth at Arran will be achieved by leveraging the power of technology, especially biotransformations. The enzyme process has proven to increase process scalability and lower cost of goods, which is a win-win for our customers.