Tag Archives: Biosimilar Compatability

Dr. Andrew J. Reason, CEO and MD, BioPharmaSpec

dr-andrew-j-reasonFollowing a Ph.D in “Characterization of O-linked GlcNAc in nucleoplasmic and cytoplasmic glycoproteins” and a short period of postdoctoral research at Imperial College, Andrew joined M-Scan in 1994 as a biochemist, and rose to become Managing Director of the M-Scan Limited and M-Scan GmbH laboratories. 

Andrew is Managing Director and CEO of BioPharmaSpec, a CRO he co-founded with Prof. Howard Morris early in 2014.

You have said anyone developing a biosimilar should attend this webinar. What would be the key takeaway message for the audience?

Structural Characterization is at the core of demonstrating comparability of Biosimilars to Reference Medicinal Products (RMPs). Successful development of a Biosimilar is always underpinned by a strong analytical package. This webinar has been designed to provide attendees with some understanding of the regulatory requirements and analytical package requirements to characterize and compare Biosimilars with RMPs.

What do your clients tell you is the biggest challenge in developing a pipeline of biosimilars?

Biologics are complicated to manufacture at the best of times. Biological processes are hard to control, and manufacturing a Biological to be comparable with a Reference Product is very difficult. Each product has its own individual challenges but it is usually the Post Translational Modifications (PTMs), and glycosylation in particular, which are hardest to control and represent the biggest challenge in producing a Biosimilar.

Unlike many other small-medium sized CROs, BioPharmaSpec has invested in having labs in different locations- how important is this global presence?

As well as our laboratories in Europe and North America, BioPharmaSpec also has a global Sales/Business Development presence with offices in Europe, North America, India and South East Asia. We feel it is important to be close to our clients and provide local business and technical support across time zones. This allows us to be on hand when needed and to act as an extension of our client’s in-house product development team.

You are a visiting Professor at the University of Warwick. How do academic collaborations support and advance the biopharmaceutical industry?

Academic collaborations allow small to medium-sized companies like BioPharmaSpec to explore and develop new processes and methods. For example, through my visiting Professorship at Warwick University we are investigating the power of combining data obtained from Circular Dichroism, FT-IR, Raman Spectroscopy and NMR for secondary and tertiary structure analysis of Biopharmaceuticals.

Throughout your career, you have travelled all over the world to present at conferences and meet with clients. What has been your favourite place and why?

It is very hard to choose as I have been lucky to visit so many places and meet some fantastic people. I think if I had to choose one place it would be San Francisco because as well as it being an interesting place to do business due to the large number of innovative start-up companies, there are also plenty of great golf courses in the Bay area! I always try to visit Napa and Sonoma for the wine tasting when I am there.

Join Andrew and BioPharmaSpec in their upcoming webinar Effective Biosimilar Comparability Studies”. Register now!