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 and managing partner of BioPlan Associates and a member of BioPharm International's editorial advisory board,
elanger@bioplanassociates.com
.
REFERENCES
1. BioPlan Associates, 9th Annual Report and Survey of Biopharmaceutical Manufacturers (Rockville, MD, April 2012),
http://www.bioplanassociates.com.
2. BioPlan Associates, Biopharmaceutical Expression Systems (Rockville, MD, 2008).
3. Biotechnology Information Institute,
http://www.biosimilars.com, accessed May 11, 2012.
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