Biomanufacturing Innovation - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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


PTSM: Pharmaceutical Technology Sourcing and Management
Volume 8, Issue 7

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,
, and a periodic contributor to Outsourcing Outlook.

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here