Gauging Biopharm Outsourcing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Gauging Biopharm Outsourcing
Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.


Pharmaceutical Technology
Volume 36, Issue 8, pp. 68-70

Projections

The survey evaluated 24 different areas associated with outsourced operations and asked respondents which activities will be outsourced "more often" during the next 24 months. More than one-third (35.4%) expect to increase outsourcing of analytical testing/bioassays. BioPlan believes much of this increase relates to product characterization, including for biosimilars.

Validation services was the area where respondents predicted the highest rate of increase (32.3% indicated high rates in outsourcing in 2012, compared with 22.1% in 2011 and 23.8% in 2010). Also, 26.2% of biomanufacturers predict they will outsource significantly more fill–finish operations during the next 24 months compared with 23% in 2011, and 25% in 2010. Other areas of outsourcing growth include: API biologics manufacturing,cell-line development, testing for lot release,and toxicity testing. Some recent decreases in predictions for outsourcing growth are in: downstream production operations, testing/product characterization, media optimization; upstream production operations, regulatory services, upstream process development; and testing cell-line stability.

Looking ahead

The biopharmaceutical industry continues to focus on productivity, efficiency, getting more out of existing internal resources, and maximizing performance from their provider relationships. Although outsourcing can improve overall efficiency and reduce costs, the management of relationships continues to be challenging and necessitates CMO/CRO flexibility to meet clients' shifting needs. Data from this study shows that CMOs are expanding their manufacturing competence through the use of novel technologies, single-use/disposable bioreactors, and other differentiated bioprocessing services. Improved services are resulting in increased adaptability, lower costs, faster turnaround, and higher yields, thereby offering more choice for biopharmaceutical companies. At the same time, the costs for using CMOs for product manufacturing are becoming slightly more competitive.

Eric Langer is president of BioPlan Associates, tel. 301.921.5979,
, and a periodic contributor to Outsourcing Outlook.

Reference

1. BioPlan Associates, 9th Annual Report and Survey of Biopharmaceutical Manufacturers (Rockville, MD, April 2012), http://www.bioplanassociates.com/.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here