Stephan O. Krause Principal Scientist, Analytical Biochemistry, MedImmune
Stephan O. Krause
"The use of more rapid, automated, and sensitive analytical methods has helped to better and more rapidly control the existing
variation in product quality. This has led to an overall increased product quality. The use of more rapid tests also means
lesser product intermediate hold times, again leading to better product quality. The use of automated on-line or off-line
testing reduces potential human errors which can hold up product release and often contributes to the high cost of quality
in our industry.
"One area of great need for improvement is the existing regulatory requirement for many countries to perform additional incoming
batch-release testing for a specific country. This additional requirement for country or region-specific release of each product
batch, intended for distribution within that country, has been in place for a long time. This is not only burdensome and costly
for the manufacturer but also prevents the use of advanced analytical technologies becaues the additional testing should ideally
be done with very similar test methods and instrumentation."
Hans-Peter Meyer Vice-President, Innovation for Future Technologies, Lonza
"The greatest development was the establishment of highly productive mammalian cell lines. The achievement has been so big
that nowadays, the problem, especially with monoclonals, is that the productivity on the fermentation side has been so good,
the industry now faces bottlenecks downstream. That is something we need to solve in the future. The drugs of the future must
also be affordable and effective. So we need to keep on this path to improve productivity, to drive the yields, drive the
titers. Fermentation has come very far, so we now need to improve the downstream side to keep costs down.
"I see a merger between small and large molecule. With a large molecule, you have to store it properly and you have to inject
it. Ideally, one would prefer a molecule which has the same effect but which is easy to store, easy to formulate, and easy
to swallow so it doesn't have to be injected. I think we will see, for example, fragment antibodies and antibody mimics. On
the other side, small molecules will become more functionalized and complex. So essentially, the two types will merge as we
understand disease and the mechanism of disease and consequently design molecules. But, due to this structural and functional
molecular complexity, chemisry will reach its synthetic limits."
Krish Venkat President AnVen Research, Pharma & Biotechnology Consultants
"In the upstream process, the first important thing is productivity. It used to be 100 milligrams, but now you can make 5
grams, and even 10 grams per liter. The second important thing is the ability to manipulate the gene so that the product can
be highly glycosylated, or so it can mimic more mammalian, human origin. Those are two key improvement areas we've seen and
third, as mentioned, is the move from stainless bioreactors to disposable bag systems.
" Looking ahead, regulations may still be shaping up, but in the plant area, we may be able to make products based from plants
cheaper and faster. I also think lots of stem cells will be produced, targeted specifically for Alzheimers, Parkinsons, and
diabetes, and so on. Overall, it will be cell therapeutics that change in the next 25 years."
Michiel E. Ultee Vice-President, Process Sciences, Laureate Pharma
Michiel E. Ultee