Biomanufacturing Innovation - Industry wants more innovation, but can suppliers meet customers' needs? - BioPharm International

ADVERTISEMENT

Biomanufacturing Innovation
Industry wants more innovation, but can suppliers meet customers' needs?


BioPharm International
Volume 25, Issue 7, pp. 22-23

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,
.

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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Pandemic Vaccine Facility Dedicated in Texas
September 19, 2014
GSK Fined in China Bribery Scandal
September 19, 2014
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
September 19, 2014
GPhA Supports Restricted Access Bill
September 18, 2014
Baxter Initiates Voluntary Recall of Potassium Chloride Injection
September 17, 2014
Author Guidelines
Source: BioPharm International,
Click here