A perk of working for a company that sells products all over the world is being able to travel without paying for it. Since the end of January I have been visiting customers and attending meetings and seminars on 3 different continents, experiencing first-hand the problems faced by scientists in a wide range of institutions and discussing how Malvern’s technologies can be used to solve these problems.
My first stop was India, taking a 10-hour flight from London Heathrow to Chennai. The City is home to Marina Beach, a sandy beach that stretches over 8 miles along the Bay of Bengal and is considered the second longest urban beach in the world. Seminars were given on Malvern’s solutions for biopharmaceutical analysis across India’s ‘biopharma belt’ including the big cities of Bangalore and Hyderabad. February saw the launch, by Biocon (Bangalore), of the world’s first Trastuzumab biosimilar, CaNMabTM. Having analysed samples in the past in order to assess the clinical usefulness to breast cancer patients of the Trastuzumab innovator drug, I enjoyed presenting the applications of Malvern’s sizing solutions, such as the Zetasizer range, to the demonstration of biosimilarity that allows biopharmaceutical companies to minimise development costs.
Bombay, Aurangabad and Delhi also made for interesting visits. Research into the effect of formulation excipients on protein unfolding, the importance of viscosity measurement to the development of viable biopharmaceutical formulations, and the means by which protein modifications can be assessed using Malvern’s various technologies were all demonstrated to analysts of biomolecules in various environments, from Universities to medical research institutes to pharmaceutical companies.
From Delhi, I flew to Melbourne via Kuala Lumpur for the Lorne Conference on Protein Structure and Function. ATA Scientific, distributor of Malvern products throughout Australia and New Zealand, exhibited at the conference, their stall attracting a lot of attention from scientists attempting to understand the protein aggregation processes that lead to a diverse range of medical problems, from cataracts to Alzheimer’s disease. Being able to track the earliest stages of such processes is important, and conferences like Lorne highlight the importance of SEC-LS technologies, such as Malvern’s Viscotek range, to the highly sensitive calculation of the absolute molecular weights of different protein aggregation states as they develop. It is little surprise that the workshop we ran at the conference, explaining the application of light scattering to protein characterisation, generated a lot of interesting questions from protein experts using Malvern instruments to predict and characterise protein aggregation processes.
In addition, staying in Lorne afforded me the opportunity to eat battered shark from a local fish and chip shop and surf in waters kept cool by currents moving northward from the West Wind Drift (Antarctic Circumpolar Current). The West Wind Drift is the largest ocean current in the world, at ~125 Sverdrups (~125 million cubic metres per second), and intercepts warm waters from the north headed for Antarctica, contributing to the extremely low temperatures experienced on that continent. Better was to come, the next stop on the trip being central Melbourne, where I had a guided tour of the Melbourne Cricket Ground (MCG), home both of Australian cricket and Australian rules football. The MCG is the the oldest continuously operating sports stadium in the world, being first opened in 1853 and playing host to the first test cricket match in 1877. Since the first grandstand was built in 1854 the ground has grown considerably, currently able to seat > 100,000 people, a number of paintings in and around the Long Room linking the largest sports arena in the southern hemisphere with its origins.
Malvern seminars were given in Melbourne, Brisbane and Sydney, one of the Melbourne venues being the Australian Synchotron, whilst the Australian Institute for Bioengineering and Nanotechnology (University of Queensland) hosted the Brisbane seminar. Given the venues, it is little wonder that the whole of Malvern’s biopharmaceutical toolkit generated a high level of interest, the Viscosizer 200, Archimedes and NanoSight instruments in particular generating enthusiasm amongst those performing research into protein therapeutics. The ability of the Viscosizer 200 to make high-throughput microcapillary viscometry measurements on highly concentrated protein samples makes it ideal for the screening of sample viscosity as part of a pre-formulation step, whilst Archimedes elegantly addresses the problem of sub-visible particle characterisation, the presence of such potentially immunogenic particles being of particular concern to biopharmaceutical regulatory authorities. Like Archimedes, the NanoSight instruments allow counting and differentiation of different particle types, the latter utilizing Nanoparticle Tracking Analysis (NTA) whilst the former uses the technique of Resonant Mass Measurement (RMM). NTA involves calculation of hydrodynamic size through the tracking of the light scattered, or fluoresced, by individual particles in solution, allowing the differentiation of different particle types in complex mixtures. NTA gives access to a new, deeper level of knowledge regarding protein aggregation, and is highly valued by researchers interested in improving the understanding of such processes, of which there are many in Australia.
From Sydney I travelled to Hawaii, crossing the Equator and International Date Line almost simultaneously. Reconfigured in the 1970s under the direction of Vladimir Ossipoff, the Honolulu International Airport terminal building has a long, low flat roof that blocks direct sunlight, with the open sides and scarcity of inner walls ensuring a comfortable breeze that keeps the building cool. The lack of full walls also affords excellent views of the city and surrounding mountains, with the 6-hour stop-over almost flying past. From here, another 10 hour flight took me to New York, with a 17th floor room in Jersey City giving me an excellent view of the Empire State Building, World Trade Centre and Statue of Liberty across the Hudson river. In America, discussions revolved around the application of light scattering parameters such as the second virial coefficient, dynamic virial coefficient, Zeta Potential and aggregation onset temperature to biopharmaceutical formulation and stability screening.
Finally, a flight from Baltimore back to Terminal 5 completed the trans-global circuit, over 4 weeks after it began. Such travel allows an accurate comparison to be made between the problems faced by protein scientists around the world, and highlights the extreme diversity of analytical goals that Malvern’s technologies can be used to achieve. From fundamental research into the cause of disease, to the development of stable formulations for innovative therapeutics, to assessing the comparability of such therapeutics, Malvern’s technologies can be used to provide orthogonal analysis across the entire drug development process.
Download application note: “Developing a bioformulation stability profile“