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Bioprocessing innovations in demand
The survey showed that a common cause for dissatisfaction with current single-use bioreactors, liners, and other equipment is they are not robust enough. Single-use equipment is still not adaptable to the more extreme mixing, heat, and other conditions involved with most microbial systems (e.g., E. coli and yeast).
When asked to rate the factors responsible for creating bioprocessing improvements in the past 12 months, the largest portion (72.6%) cited "overall better control of processes," followed by "improved downstream production operations," and "use of disposable/single-use devices."
Vendors' focus on R&D
To evaluate how well vendors' R&D match industry needs, the BioPlan survey asked about budget changes in 2012. Vendor respondents reported an average 1.9% increase in basic R&D for product development, a 2.4% increase for hiring new staff, a 4.3% gain in sales budgets, and a 3.4% uptick in capital-equipment purchases.
Bioprocessing innovations trends
Several major trends have contributed to improved bioprocessing in the past decade. Legacy expression systems from the 1980–1990s, such as Chinese hamster ovary systems, yeasts, and E. coli have shown improvements in process yield (2). Mammalian-cell culture yields over 10 g/L are expected, and mammalian expression systems thoroughly dominate as classic microbial, including E. coli and yeast systems, are being displaced for in-house systems. Cell-line engineering and product-specific expression optimization are rather common in supporting higher yields and better product quality, particularly as off-patent high-yield cell lines go off patent and become more widely available.
Preclinical, clinical, and other precommercial manufacturing is dominated by single-use/disposable equipment Single-use equipment is on the verge of being adopted for commercial manufacture (3).
Major advances in sensors, automation, and process control have been made for improving quality control, such as single-use sensors and sensors for new analytes. Also, manufacturing systems can now be modeled, which facilitates process and facilities design and removes bottlenecks.
Eric Langer is president of BioPlan Associates, tel. 301.921.5979, firstname.lastname@example.org
1. BioPlan Associates, 9th Annual Report and Survey of Biopharmaceutical Manufacturers (Rockville, MD, April 2012), www.bioplanassociates.com
2. BioPlan Associates, Biopharmaceutical Expression Systems (Rockville, MD, 2008).
3. Biotechnology Information Institute, www.biosimilars.com, accessed May 11, 2012.