In the first article of our new ‘From the Factory’ series, Ajit Kanetkar, head of process technology & training at ACG explains why adopting new technologies is not always a swift transition.
New technology
The pharma manufacturing industry has witnessed considerable change over recent decades, such as new drug delivery systems, automation, new regulatory changes and more.
And looking at the transformation one would believe that the industry has enthusiastically welcomed all changes with seamless transition. The reality is different.
Apprehension in relation to costs, uncertainty when it comes to adoption or regulatory considerations often means that the actual transition to new technologies is not so swift. Typically the majority of pharma companies adopt a ‘wait and see’ attitude and follow those who take a lead in acquiring new technologies.
Pharma manufacturers need to consider many factors when updating processes or technologies.
Regulatory changes
The introduction of regulations that require assurance on areas such as: validation, reproducibility and the availability of PAT tools ought to nudge a company into looking for a technology upgrade.
Market factors
- The business potential for products made with a particular technology may lure some companies to acquire necessary technologies.
- The creation of capacity for a technology: a company might have an existing basket of products that might be categorised into one delivery system such as modified release pellets. A new technology cannot be commercially viable if only acquired for one to two products. The company must manufacture at least three to five similar products, or have a firm plan to develop & launch more products in this category. They would then be more open to absorbing new technology and the creation of fresh capacity.
- Introducing new manufacturing processes and technologies means companies can produce products using complex processes or high-end technology, which can ward off some competition. Companies may also be propelled to opt for a technology to keep pace with competition making comparable products and who have moved to such technologies.
Commercial and operational factors
- It may be necessary to have a technology upgrade to improve efficiencies and consistency in output. This can contribute to better assurance levels, reduction in rejection and rework and more assurance in product quality.
- Some companies are willing to take the investment risk when it comes to adopting new technologies. This is provided they get an assurance from the supplier, or a technology partner with expertise to provide support from feasibility studies through scale-up, stability, validation with process optimisation, to commercial manufacturing of the products.
- The proximity of the technology supplier can often be paramount. The presence of a manufacturing base with service support from a known supplier in the region opens customers up to considering exploring a new technology.
Most new developments over recent decades have related to the hardware used to improve operational efficiencies or a new delivery system with a focus on scalability, ease of validation and data acquisition, storage, retrieval, recipe management and security. However new factors are driving another change that is being adopted with speed by the pharma industry unlike adoption of technologies for core processing and packaging. This is not surprising as they are being driven to maximise the use of resources and do not require changes in existing processes.