One of the areas where the biomanufacturing directors and contract manufacturers expect to see a significant impact to their
operations in the coming years is in the adoption of disposable technologies for the manufacture of biologics. Below are a
few of the comments made by the biomanufacturing directors about the impact that the use of disposables on their operations
and the improvements that they expect from the use of disposable technologies:
- "Disposables will come more into use. They cut down on time and cost, so there are dual savings."
- "Disposable technologies for tissue culture and buffer bags are the newest products to have an impact on our operation."
- "Only the implementation of additional disposables will decrease our contamination rate. Our success rate was really low when
I first started here. Now it is up to 50%."
- Disposable technologies can be applied in our operations, which will reduce our validation requirements."
Further analysis of the use of disposable technologies in the manufacture of biologics, shows that over half the biomanufacturing
directors in the survey are currently using disposable reactor technology and almost one-third of the biomanufacturing directors
are planning to adopt this technology in the near future. Most of the biomanufacturing directors state that their companies
primarily use disposable technology for small-scale and preclinical production. While a majority of the biomanufacturing directors
in the study use disposable technology, very few of the biomanufacturing directors require their contract manufacturer to
use disposable technologies in the production of their biologic products.
The decision to manufacture using disposable technologies or stainless steel by the contract manufacturer is driven more by
production volume, phase of production, or the specifics of the project. The advantages of disposable technologies most often
stated by the biomanufacturing directors are easier validation, avoidance of cleaning processes, and flexibility. The biomanufacturing
directors' concerns with the adoption of disposable technologies for the production of their biologic products include issues
involving scalability, profitability, and compatibility with certain production technologies. Overall though, the biomanufacturing
directors are optimistic about the use of disposable technologies for their production processes. Below are select comments
by the biomanufacturing directors about the advantages in using disposable technologies in the production of biologics:
- "We want to focus our effort on the task at hand rather than cleaning."
- "Disposable technologies are the way to go. They provide more flexibility."
- "Disposables have the advantage of cheaper validation and the disadvantage of more upfront expense. However, the advantages
and disadvantages may balance out. They are beneficial in that they save time and reduce cleaning. Overall they are a good
move, and we are going in that direction."
- "Disposable bioreactors are great for the production of small batches during development because you eliminate the cleaning
of bioreactors. However, for scale-up it is questionable how good they are."
- "We see a big advantage to going with disposable technologies. It improves our compliance process, no cleaning is required,
and validation is simpler. On the other hand, there is an upfront cost disadvantage."
Process-development is one of the key services biopharmaceutical manufacturing directors seek from biopharmaceutical contract
manufacturers with the emphasis on improving yields and productivity. In the survey, a plurality of biopharmaceutical manufacturing
directors states that they outsource process development. The rest of the biopharmaceutical manufacturing directors either
keep process development in-house or outsource on a case-by-case basis.
Almost all process development outsourced.
Below are select comments from biopharmaceutical manufacturing directors about their decisions to outsource process development:
- "We outsource 100% of our process development. We will decide to outsource process development on a project basis. In addition,
we will outsource cell-line development."
- "Ninety percent of our process development is outsourced. Our decision to outsource most of our process development is based
on our limited internal capacity. We look to our CMO to provide nearly all stages of process development."
- "We do about 25% of our process development in-house. Our decision to outsource most of our process development comes from
a combination of not having the required facility infrastructure, so that the real manufacturing must be outsourced. We want
a CMO to provide improvements in yield and cost, reliability of production upstream, and downstream processing. Basically,
we want the CMO to improve on our technology and thereby improve the cost of production."