Magazine Article | December 7, 2010

Contract Manufacturing's Role In Supporting Big Pharma During A Healthcare Crisis

Source: Life Science Leader

By Rick Lapointe, VP of technology, OsoBio

As everyone knows by now, the world is in a crisis due to the pandemic outbreak of the H1N1 virus, better known as swine flu. The need for effective vaccines to fight this outbreak has never been more urgent. The decision by the government to produce mass quantities of the H1N1 vaccine was made relatively late in the flu season, thereby creating quite a challenge for the pharmaceutical industry. “Big Pharma,” along with some of the smaller players in the vaccine business, were asked to accelerate development of a flu vaccine to fight the H1N1 virus. This request came at a time when these companies are in full production of the seasonal flu vaccine. This meant that the capacity necessary to produce both vaccines in massive quantities was not available. Therefore, big pharma had to turn to the only other source of sterile injectable manufacturing capacity, contract manufacturing organizations (CMOs) such as Hospira, DSM, and OsoBio.

With the need to produce large amounts of vaccine in a very short period of time, the contract manufacturing organizations were asked to initiate and execute a production plan within a very short period of time. In order to be prepared for the challenge, a great deal of forward planning and preparedness must be in place by the CMO.

What can be done by the CMO in advance to be prepared for this urgent and somewhat rare request? There are many things that prepare a CMO to meet these unusual demands and are listed below:

  • Manufacture the existing product line as efficiently as possible to ensure capacity is available whenever needed.
  • Staff the facility with the capability of taking on new and fast-track projects at a moment’s notice.
  • Staff the facility with personnel who have a wide range of experience that will cover the standard project to the most complex of projects.
  • Assure that the facility is in good regulatory compliance with the FDA and other worldwide regulatory agencies in Europe and the rest of the world.
  • Establish and maintain a good reputation in the CMO industry such that you are trusted by big pharma in a time of need.
  • Maintain a wide range of manufacturing capabilities such that difficult-to-produce products and those that require a specific regulatory requirement can be processed in the same facility.

In addition to the operational plans, a flexible business development method along with a skilled negotiator should be prepared to meet the immediate needs of the drug sponsor. Some of the considerations are listed below:

  • Is there a standard format contract available that can be quickly modified during the negotiation phase?
  • Is there a standard quality agreement that will not require extreme modification?
  • Is the CMO willing to negotiate pricing which is competitive in the market?
  • Does the CMO have a good handle on market pricing during a crisis?
  • Is the CMO willing to accept a letter of intent in order to start the project as soon as possible?
  • Should the CMO consider a take-or-pay arrangement? This tactic is especially important when the drug sponsor is contracted with the government. The government can cancel any contract for convenience, thereby leaving the drug sponsor and the CMO “holding the bag.”

The contract manufacturing industry has been asked to step up during a time of crisis. Without the visionary evolution of the industry, big pharma would not have been able to supply the necessary quantity of H1N1 vaccine which has been saving and will continue to save lives around the world.