Outsourced Vaccine Development - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Outsourced Vaccine Development
The authors discuss how strategic outsourcing to contract manufacturing organizations that have technical and regulatory expertise can add further value during vaccine development.


Pharmaceutical Technology
Volume 33, Issue 7

The recent influenza A H1N1 / H5N1 outbreaks, as well as increased concern over biodefense, have dramatically raised public interest in vaccination to "front page" news. Together, these events are driving demand for rapid development of novel vaccines. In both the public psyche and around the board tables of large pharmaceutical companies, vaccines are undergoing somewhat of a renaissance.


Images and figure courtesy of Eden Biodesign, Inc.
In 2007, vaccines demonstrated significant market growth, outperforming most other sectors of the industry, predominantly due to the success of Merck's (Whitehouse Station, NJ) Gardasil and continued strong performance of Prevnar from Wyeth (Madison, WI). This growth and a market of approximately $16.3 billion in 2007 (with projections of a $100 billion market by 2024 based on a similar compound annual growth rate)(1) has attracted the attention of companies not traditionally associated with vaccines. The vaccine industry is at present an oligopoly, dominated by major players Merck, sanofi-aventis/pasteur (Paris), GlaxoSmithKline (GSK, London), Novartis (Basel,) and Wyeth (Pfizer). However, the high performing potential of vaccines now represents an attractive prospect for other large pharma companies with concerns over diminishing returns through their traditional pipelines.

In addition to corporate organizations, the cost effectiveness of vaccination rather than treatment is widely recognized by international health authorities. Further sources of funding from philanthropic organizations such as the Bill and Melinda Gates Foundation have boosted the development and availability of pediatric vaccines in developing countries. Likewise, there continues to be high levels of biodefense funding for vaccine research and development (2).


Figure 1: Biotechnology medicines in development by product category.
Each of the above factors represents a driver for growth in vaccine development, which perhaps explains why there are more vaccine products (prophylactic and therapeutic) in development than any other class of biological medicine (see Figure 1)(3). This growth will only be sustained through innovation and strategic development, and although the biopharmaceutical industry has come a long way since the earliest days of vaccine manufacturing, the challenges remain fairly constant: What is the most reliable and cost effective manufacturing method? How does one ensure that the starting materials and final product are, respectively, consistently safe and of high quality? Who can manufacture the amount of vaccine needed for clinical trials and, eventually, commercial production?

In terms of both biochemical composition and methods of production, vaccines represent the most diverse class of biopharmaceuticals. Unlike monoclonal antibodies (mAbs) that are now produced and analyzed using relatively generic platform processes and methods, the complexity and variety of vaccines generate many challenges during process design and development. In this paper, the authors review the technological advances that will expedite vaccine development as well as add value to it. They also outline points to consider when choosing a contract manufacturing organization (CMO) for vaccine development projects.


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
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
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