The approach gains increased importance as public health experts warn that current production capacity and response times would not suffice in the event of a pandemic.
Speaking at the 10th annual China International Pharmaceutical Industry Exhibition in Shanghai, Ian Sellick of Pall Corporation, described how the higher binding capacity of Pall's single-use Mustang membrane capsules for large molecule applications compared to conventional resin- or gel-based column chromatography.
Mustang technology is particularly well suited for vaccine manufacturing for two applications.
At the initial capture step for viral and DNA vaccines, viruses and plasmid DNA are very large molecules and therefore conventional chromatographic media technology have limited capacity.
Mustang technology has at least 10 times larger capacity than conventional media and can operate at much faster flow rates.
As a result, the capture step can be performed often in less than one hour. This also presents strong benefits both in terms of process duration, maximising the turn over time of equipment and recovery of biological activity.
Just like with other biotechnological processes, Mustang technology is proving to be very efficient for the removal of contaminants such as DNA, HCP and viruses where applicable.
Therefore, the main advantages are linked to the capacity/flow rate points associated with the single use technologies mentioned above, which further simplifies both the validation and the process operation.
Mustang technology's other major advantage reduces the timeline to get equipment in place as well as qualification and validation time.
This is key in Europe where a directive applicable since May 2004 (linked to Annex 13 cGMP) mandates the fact that all equipment should be qualified and process validated as much as possible.
Beyond this, some vaccines present some unique challenges in terms of biosafety, and therefore have to be produced in a BSL-2 or BSL-3 type of environment.
Disposable technology can virtually eliminate any contact between the microorganism used to produce the vaccine and the operators, therefore contributing to the overall safety of the process.
"Disposable technologies that efficiently process larger volumes can play a pivotal role in moving the majority of vaccines from clinical trial to full-scale manufacturing,": said Sellick.
Viral vaccine development is governed by stringent regulatory controls and can take as long as eight to 12 years costing anywhere from $300 to $800 million.
Various governments have responded swiftly to the threat of avian flu, taking unprecedented measures in response to the potential pandemic. The US government has ordered 2 million doses from Sanofi Pasteur, despite the fact that the vaccine is still in clinical trials. The government can decide to overrule the regulatory authority should it see a major danger for the population.
However the question of exactly how 2 million doses will treat the 250 million inhabitants in the country is one that still remains unanswered.
According to Dr. Hélène Pora, vaccine application development director at Pall Life Sciences, the main issue regarding inefficient vaccine manufacturing was the way flu vaccines are being produced.
She told InPharmaTechnologist.com: "All the vaccines commercialised now use egg-based technology. Eggs have to be ordered more than one year before production, and need to be very stringently controlled," she said.
"The process is long, and each egg needs to be inoculated one by one (despite the fact that this is an automated operation). As a result, there is no possibility of ramping up the production rate very quickly, should it be needed."
According to the WHO Website, there is a worldwide global production of 250 million doses. However, the problem is the majority of avian flu vaccines are in clinical phases, so there is not as yet any commercialisable vaccine.
"The Mustang technology is spreading around the biotechnological world, and is being selected for various applications in the production of gene therapy vectors, MAbs, and other biologically-related compounds," commented Pora.
In commenting on the importantance of public-private partnerships in addressing thethreat avian flu poses, Pora said that this one is a more challenging questions.
"I believe the fact that governments and non-governmental organisations (e.g. WHO) are putting a lot of effort and money into avian flu issues, has raised the interest of vaccine manufacturing companies."
"I believe it will also have a positive impact on the development of cell-based technology for the flu vaccine, because it is still the hen that lays the egg, and should avian flu spread everywhere, manufacturing avian or even standard flu vaccines would really become an issue," she concluded.