The Biopharmaceutical Manufacturing Survey - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

The Biopharmaceutical Manufacturing Survey
A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 7

Figure 3: Product mix. Total exceeds 100% because multiple responses were allowed. mAb is monoclonal antibody.
The press has been so focused on monoclonal antibody (mAb) drugs, that we were surprised to learn that a majority (56%) of respondents manufacture protein and peptide drugs other than mAbs, which are manufactured by 43% of respondents. Almost 18% of respondents manufacture nucleic-acid based drugs, and 17% of respondents manufacture cells for tissue and cell therapies—a field on which many are heaping high hopes, especially now that government funds are available for embryonic stem-cell research (see Figure 3). Thirty-eight percent expect their companies will manufacture follow-on biologics; 22% expect their companies will not manufacture follow-ons; and 39% don't know.

Production challenges

Figure 4: Technical problems reported in protein manufacturing. Total exceeds 100% because multiple responses were allowed.
We queried respondents about the challenges they face manufacturing their respective products, and among manufacturers of protein-based drugs, we found something of a schism. Fifty percent—fully half—of those producing protein drugs, including mABs, said that they had difficulty producing high enough product yields. And yet 44% reported that purifying protein products was a challenge because yields were so high. Product instability was a problem for almost 40% of respondents, while contamination was a problem for 20% (see Figure 4).

Stability seems to be a problem confronting 56% of producers of nucleic-acid based drugs, with another 50% reporting difficulties with purifying these products. Thirty-six percent have formulation problems, and almost 28% find it a problem to produce adequate yields.

Industrial-scale cell manufacturing is still in its relative infancy, as evidenced by the fact that 62% of respondents said that developing a manufacturing process posed a challenge to them. Forty-three percent reported difficulties maintaining product stability and uniformity, while 32% said that formulating cell-based therapies posed a challenge. Almost 30% have difficulty finding bioreactors of adequate volume to accommodate their product yields.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

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.
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.
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: Pharmaceutical Technology,
Click here