Source: BioPharm International
Volume 2010 Supplement, Issue 7
To assess current trends in laboratory equipment, BioPharm International turned to Karl Rix, PhD, CEO, DASGIP BioTools, LLC; Erika Lapinskas, PhD, global product manager, Sartorius Stedim Biotech; and Morgan Polen, vice president of application technology, Lighthouse Worldwide Solutions.
Q: What are the major trends in laboratory equipment for biopharma process development and quality control?
Rix: Analytical devices are used for in- and at-line process analytics. PC-based analytical equipment and bioreactor controllers with online data exchange (i.e., OPC) are getting more popular.
Polen: More monitoring along the lines of process analytical technology (PAT). Also, companies [are] more concerned with the enforcement of Part 11. We see a lot of things that used to just sail through the validation groups getting a lot more scrutiny.
Lapinskas: Based on user demand, vendors now are incorporating process analytical technologies found in large-scale equipment into process development and research-level equipment. Examples include the miniaturization of bioreactors and the incorporation of optical-chemical sensing technology to create a more efficient, reliable, and cost-effective model for scaling up cell cultivation.
Q: Is there a trend toward disposables?
Rix: Up to now, items were tied mostly to manufacturing. First, products for R&D were available. Pricing seems to be considered a limiting factor.
Lapinskas: Much of the more sophisticated equipment has both a hardware and a single-use component that is changed out with each use. This trend increases as there is a greater customer understanding of the environmental impact and total cost of ownership of reusable components-including the risks of cross-contamination, cleaning costs, and of course, labor.
Polen: More disposables are being used. This is not green. But the industry as a whole is not environmentally focused.
Q: What is the state of the industry in terms of adopting PAT-based methods?
Rix: For new product development, the industry is looking into PAT methods. We are still in the early beginnings.
Polen: Some companies are pursuing PAT extensively; others have a wait-and-see attitude.
Q: Do you see a lot of interest in laboratory-scale, high throughput screening systems for process development?
Lapinskas: Absolutely. When we introduce a new technology for screening parameters for a process step, the first questions from the biopharmaceutical companies we work with are always, "Can we do it with more units?" and, "Can we automate it further?" Screening 12, or even 100 media variations is not enough. Now companies want to do at least hundreds, varying other parameters in parallel, creating potentially many thousands of conditions.