by Christophe Grimm & Ian Schwartz
The market for immuno-therapeutics such as monoclonal antibodies and antibody-drug conjugates (ADCs) is becoming increasingly competitive. Biopharmaceutical companies continue to develop innovative new products to treat existing disease targets while biosimilar companies are attempting to steal market share from licenced products. To be successful, companies must reach the market as quickly and efficiently as possible in order to minimize their costs and maximize their chances of commercial success. Increasingly firms are also paying greater attention to process economics and the target cost of goods their processes must deliver.
Single-use manufacturing technologies allow companies to install a production capability quickly and with less capital investment. However, companies must still perform process development activities before they can implement this equipment. Firms that take full advantage of the knowledge gained from previous projects can reduce significantly the duration and expenditure allocated to these activities. This allows them to focus their attention onto a smaller number of critical variables that will allow a product with the necessary quality attributes to be produced with the required productivity.
A platform process approach to development is one in which companies gain considerable efficiencies by using standardized approaches from process design through to commercialization. Platforms include the protocols and tools used during early phase development through to the sequence of steps installed in the production process.
By standardizing around a platform, firms can reduce complexity in their operations and supply chains. This can lead to benefits such as reducing costs associated with training operators and reducing the risk of single-use component ‘stock outs’. Global manufacturing assets can be designed in advance to accept platform processes allowing companies to transfer process around the world seamlessly and with reduced risk of process failures at the recipient facility.
Companies can use the knowledge and experience they accumulate on a platform to guide their process development and facilitate their regulatory submissions through experience and lessons learned. Firms can review existing project data for its applicability to new regulatory submissions. Some studies may be transferable and could reduce the burden of testing during new projects.
How then can biopharmaceutical companies reap the benefits of process platforms? We believe that the key is to consider carefully overall objectives when developing new drugs. Our experience shows that by implementing platforms, firms can enhance considerably the speed and predictability of the development and commercialization of mAbs and ADCs.
We hope you can join our webinar to find out more.