Realizing the market potential for biosimilar antibodies, Asia is expected to be the biosimilar hub in times to come. The Asian advantage rests on its bio-specialized manpower, consolidation of the R&D infrastructure, expanding its world-class clinical trials and production infrastructure by strategic alliances, reinforcing export capability by global partnering and the significantly lower cost of production.

Setting up a manufacturing facility

Since antibodies are large molecules and dosage is in gram quantities, a larger manufacturing plant is required to produce them. Capital investment represents the largest share of financial risk when scaling up is required. The cost of setting up antibodies manufacturing facility will depend on the scale of operation. If a new facility is planned, it will be important to know beforehand the number of products to be manufactured and amount of material to be produced for marketing. Since most companies would be looking at a ‘basket of biosimilar mAbs', a multi ton facility will be desirable to produce multiple products to maximize payback. Again, the market demand would dictate the scale-of-operations. A higher capacity, under-utilized plant may paradoxically result in higher rather than lower COGs for biosimilars. Thus, new production facilities for biosimilars can only provide maximum economic benefit if they are designed with multiple products in mind.

It will be important to understand that a multi-product facility will require a longer changeover time (10-14 days) when switching from one antibody to the next as compared to the traditional dedicated facility. This change over time is critical in ensuring proper cleaning, replacement and sanitization of equipment. Thus, smart facility design, proper production planning and implementation of technology which minimizes changeover time are all tactics which can be employed to optimise the design of multiproduct facilities.

Adoption of single-use and disposable technologies is one of the most effective ways to minimize the need for early capital investment. Although this may increase per batch costs, eventually it will results in better pay backs as the costs will only be incurred when product is produced. A new company should weigh both the options - single-use, disposable bioreactors as well as the traditional stainless steel bioreactors and plan the manufacturing plant likewise, perhaps starting with the disposable technology and, when the revenues start flowing in, focus on building the capital investment.

Another important point is development of robust processes. We have gained immense knowledge in process development over the past few years. Incorporating Process Analytical Techniques (PAT) and Quality by Design (QbD) will ensure better control over the process, based on good science and quality risk management. Although, a biotech drug application using the QbD approach is yet to be approved by the FDA, the QbD principles are already being widely adopted by biotech firms around the world.