BioPharm International spoke with Neil Lewis, chief technology officer at Malvern Instruments, about the manufacturing and analytical challenges
associated with biologics.
BioPharm: According to IMS Health, biologics are expected to account for approximately 17% of total global spending on medicines by
2016, and 7 of the top 10 global medicines by spending will be a biologic by mid-2017. Also, by 2015, says IMS, sales of biosimilars
are expected to reach between $1.9–2.6 billion, up from $378 million for the year to the first half of 2011. How is Malvern
Instruments, which is largely known for its solid dosage capabilities, positioning itself to address this growth?
Lewis: Over the past decade, as the industry has moved towards new types of molecules and new methods of delivery, we have increasingly
been providing instruments for protein and nanoparticle characterization. Our portfolio of products for protein characterization
especially is growing rapidly, but more importantly Malvern has embarked on a well-resourced and dedicated program of high-level
partnering for technology development, in collaboration with a number of biopharmaceutical companies and respected academic
leaders in the field. Through this program, our partners gain early access to emerging technologies and provide the iterative
feedback that ensures we quickly develop the right measurement technologies for the industry.
Malvern's Bioscience Development Initiative is served by a dedicated team of scientists and engineers who are based at our
facilities just outside of Washington, DC. We work with academia and small startups to access leading-edge technology, and
with more established companies to license it in, we can test concepts and engineer prototypes to provide industry partners
with early access to the measurement solutions of tomorrow. This partnering approach is being very well received by an industry
that has cited analytical testing as one of the major bottlenecks in the process of screening new candidate molecules.