Trends and Challenges in Biologics Outsourcing

In the 2011 Pharmaceutical Technology Outsourcing Survey, bio/pharmaceutical companies were expecting to increase their contract-services spending in 2011. Have you seen evidence of this?

Dr Stephen Taylor. Vice President and Commercial Director at Fujifilm Diosynth Biotechnologies.We have seen a continued trend to increased outsourcing of both process development and manufacturing across the board from both biotech and pharma companies. The challenge for us has been to be cleverer in the increasingly competitive landscape, and to seek pursue both technical and business innovations to create and deliver a better service.

Over the years, outsourcing has grown from being a short-term tactic into a long-term strategic alternative. What factors have affected this trend?

Tactical or strategic outsourcing? These are probably misused phrases to describe outsourcing approaches. Really, the approach is very dependent on the depth and nature of pipelines, whether for biotech or pharma company. We are constantly watching to see how customer needs change and then adapting accordingly. The entire healthcare sector is in a greater state of flux than ever before and as a CMO we must be alert and responsive.

As industry increases its focus on biosimilars, has the complexity or scope of your projects changed?

I’m not sure if biosimilars are the main cause, but we are certainly aware of growing product complexity as customers create more effective and selective products. In particular, we have had to develop strategies that use multi-product facilities to make short campaigns with frequent product-to-product changeovers.

As manufacturers are increasingly adopting QbD, have you seen an expectation that their outsourcing providers will also implement QbD?

QbD is an integral part of our research and development philosophy as we seek to find ways of fast-tracking products through development and underpinning validation success. We have been applying this approach before the phrase QbD was coined!

Drug shortages are on the rise, especially for many crucial drugs, such as those targeted to treat cancer. A recent article in the New York Times cited uncertain supply chains and inadequate capacity as the reasons. Would you agree with that?

We’re not aware of under-supply issues. Biologics are complex and expensive products so innovative supply chains are fundamental to manage the peaks and troughs, as well as the difficulties associated with accurate forecasting.

Is it a fair characterisation to say that there is a general overcapacity problem in most service categories?

Capacity means so much more than vessel sizes and utilisation. There is integration across research and development, to API manufacture and drug product manufacture, and although there may be stainless steel overcapacity, I would also suggest that there is a skills undercapacity! We need to encourage more top talent to build careers in bioprocessing and manufacturing, and help the entire industry find better and more cost effective ways to develop and make the next generation of critical medicines.