Q: Traditionally, Sanofi has been very stainless-steel oriented. Why have disposables now come to the forefront?
Yes, it has taken us time to come round to the benefits of disposables. At a high level, the benefits are clear, but we believe
it is always important to judge the features and benefits of disposables in relation to specific projects, to make sure we
choose the best option for a specific application in an existing process. The high-level benefits that need to be verified
or measured in the context of specific projects include:
- Reductions in capital expenditures and risk, by delaying spending and investing later.
- The potential to downgrade room classifications by using closed disposable systems. Such downgrades simplify gowning procedures,
which offers benefits from the human perspective and in terms of productivity.
- Economic benefits. Disposables clearly offer economic benefits: We are able to downsize water systems, eliminate a lot of
stainless steel, and considerably simplify the facility. But again, the level of economic benefit will depend on the specific
project, the type and scale of the process, existing capacity, skills, and lifecycle costs. As part of this program, we have
selected analytical tools that enable us to conduct such an economic assessment.
- Regulatory impact. The FDA is pushing the industry toward disposables because there is less risk of cross contamination, and
this is of course extremely important for vaccines. Until now, we have had a policy of one building per vaccine—total segregation.
If we can demonstrate that we are able to eliminate the risk of cross contamination through closed disposable systems, we
could potentially have multiproduct vaccine manufacturing operations.
- The potential to gain a competitive advantage for market access through speed to market and flexibility in terms of production
capacity. The need to adjust capacity is key for vaccines, because it often is difficult to judge the exact manufacturing
capacity requirements for a vaccine. When there is a new product launched on the market, there is a virgin population to vaccinate.
After all the people in that group have been vaccinated, supply needs will be reduced to newcomers. As a result, phasing the
production volume of vaccines to avoid under- or over-supply is not always easy.
- The ability to set up a new process very quickly, as in the case of a pandemic. This was demonstrated last year with H1N1.
- In terms of specific risks related to disposables, equipment quality and procurement issues need to be assessed. A permanent
element of our evaluation is our commitment for long-term supply, so we need to assess the sustainability of any new technology.
Q: Do vaccine manufacturing processes have specificities that affect the way disposables can be deployed?
Yes, they do indeed. One important point to note from the outset when talking about vaccines is that vaccines are given to
healthy human beings. As a result, the regulatory requirements for vaccines are extremely stringent; the thorough guarantee
of product quality comes first. Apart from that, typical issues are the requirements for decontamination and waste management
of disposables when working in virally contaminated areas. Also, live viral vaccines are manufactured in a biosafety level
Q: What specific issues do vaccine manufacturers need to address in relation to biosafety level 2 when implementing disposables?
Disposables entering and leaving a biosafety level 2 environment need to be totally contained, so they require more outer
packaging. This packaging needs to be designed in such a way that it is effective whilst not creating additional manual operations
that would negate the inherent flexibility that disposables offer. Specific training and solutions in handling disposables
are required in that respect. Additional packaging also means additional storage space is required.
A method we have found effective for limiting the amount of decontamination required for disposables is leaving disposable
equipment in lower classification areas and using aseptic transfer ports to transfer them into the contained areas.
Another area where the implementation of disposables is not simple for vaccine manufacturers is managing the decontamination
and waste of microcarriers; they must be separated from the disposable bag after use.