AAPS PharmSci 360: Quotes that carry
The three-day conference held many educational sessions, rapid-fire talks, and case study presentations. For each day, in-PharmaTechnologist chose to select talks that spoke on issues of broad interest across the pharmaceutical industry.
Monday – November 5
Keynote: Engineering First Principles Applications to Pharmaceutical ManufacturingBernard McGarvey, a retired engineering fellow at Eli Lilly & Company, spoke on the first principles-based approach of pharmaceutical manufacturing. He delved into the topic and how it improves effectiveness and efficiency in manufacturing.
“First principles are the fundamental causal physical relationships that constrain the behavior of a process, or system. If you try to operate your systems and try to break them [the first principles], it’s not going to work.
“We’re [the industry] really trying to implement ‘quality by design’. It’s relatively new to the pharma industry.
“The overall purpose [of quality by design] is to create, implement and maintain [a] process that delivers all that is required, reliably, from the first day.”
Tuesday – November 6th
Keynote: Continuous Manufacturing and the Role of Models in Implementing Continuous Manufacturing Sharmista Chatterjee, division director of the office of process & facilities and pharmaceutical quality at the US Food and Drug Administration, delivered a keynote presentation on using design models to benefit continuous manufacturing (CM). He noted that in the last four years considerable progress with CM has been made and how implementing models can give the process even more traction.
“With the advent [of] CM we do see [the use of] models. In addition, we do see some models for residence time distribution (RTD), in these [models] we’ve seen them being used for different things like feeder limits, and material traceability.”
“Models can be divided into three different categories: mechanistic first principle, empirical data drive, and hybrid, which is a combination of the two in the CM space. We have seen models that can fit in all three categories.”
“Models can support pharmaceutical development as well as the implementation of modern pharmaceutical manufacturing concepts, such as CM including RTRT continual process monitoring, and process control.”
3D Printing as an Approach to Design and Manufacturing of Pharmaceutical ProductsJoerg Ogorka, head of early-stage development at Sandoz International, gave a talk on the developments that have been made in the 3D printing process and the applications to drug manufacturing. One of his biggest points was the requirement to fundamentally rethink the manufacturing process to optimize tablet design and make drug delivery more efficient.
“We would imagine that with this, you can create layers [of API] with different binders and different powder composition…we can create different profiles for the same tablet.”
“I strongly believe all these things can be done, once we learn to control each parameter, all these things can be done.”
Wednesday – November 7th
Adaptive Process in Pharmaceutical Development and Manufacturing Markus Krumme, unit head of continuous manufacturing at Novartis, gave a presentation that reminded the pharmaceutical manufacturing world to "never stop the line." He explained how continuous manufacturing can minimize waste and maximize efficiency.
“While we call it six sigma, or call it everything is working at the same time, it doesn’t matter.”
“[If a problem on the line occurs] reduce the line speed as much as you possibly can, interfere, then get it back up – but never stop it.”
“Bottom line is: When you have these things, how can you keep the line in flow as long as you can? The idea is, when you have an issue you scale down the production rate but you keep it afloat. Then you interfere like in a Formula One race – you fix the issue and then you scale it back up.”
CAR-T Revolution: Opportunities and Challenges Stephen Grupp, chief of cellular therapy and director of translational research at the Children’s Hospital of Philadelphia, was one of the speakers at the closing plenary presentation that concluded the conference. His work on chimeric antigen receptor (CAR)-T cells in pediatrics and the revolutionary change the technology has made in pediatric oncology was highlighted in his talk. Stephen mentioned the challenges that have been seen in using CAR-T, and also the moments of success that have changed the course of CAR-T and its use. He highlighted a few issues that still need to be addressed to make the therapy better – cost and manufacturing efficiency, but still mentioned the wonders the therapy was capable of.
“The manufacturing process is a bit complicated, the fact that this actually works at pharma scale is astonishing to me."
“It’s too expensive, we could address the cost thing [and] we’re going to have to address the cost issue."
“It’s been amazing to be to see these patients recover as quickly as they do.”
