Beneath the surface

NGP talks to two industry experts about the challenges facing manufacturers of surface technologies.

From your perspective, what are the current hurdles being faced by the surface technology and manufacturing sectors, and how can they be overcome?

Lester Mills. The manufacturing industry is faced with increasingly stronger competition and the need to increase efficiency and reduce costs. At the same time over the last two years, many customers have been significantly affected by the financial crisis. Both these effects have come together and resulted in a very severe business climate for many manufacturers.

Nevertheless, there are also opportunities in such an environment, as only stronger players are likely to survive. Also, there remains strong growth in markets outside of Western Europe and the US, namely in the BRIC countries.

Manufacturers and suppliers with differentiated products and technologies may be better aligned to prevail and certain therapeutic drug categories such as oncology, for example, will remain attractive for innovation and growth especially in the next few years.

The dramatic increase in the use of generic drugs will be a necessary part of managing healthcare for an ageing population in many countries. However, this is an opportunity also and as Bachem has a significant business in generic peptides and small molecules, there are definitely also some positive perspectives to this dynamic.

Jeffrey L Mooney. With the increase in more stringent government regulations and heightened competitive pressures, gone are the days of spending hundreds of millions of dollars on state-of-the-art facilities. Pharmaceutical companies are passing on these large capital expenditures and, instead, opting to focus on manufacturing processes by, in part, identifying and utilising scalable products and technologies that allow for smaller projects that are highly targeted. This move to more scalable technologies, such as disposable bioreactors and synthetic, non-biological cell culture surfaces, allows pharma companies to explore many different options simultaneously while minimising costs, improving results and decreasing the effects of biological influences.

Stem cell research continues to advance and is playing the role of 'game changer'. Many clinical trials today use stem cells, especially in CNS, heart conditions and diabetes, and as these clinical trials become successful companies will need technical solutions that allow for ease in scale-up of cells from the lab through to production.

Furthermore, the use of contract manufacturing organisations (CMO) to meet economic cost targets is also playing a role and shaping the industry. The question becomes whether pharma and biotech companies will continually move to CMOs or if the final solution will be a CMO with all forms of scale-up handled in-house. The answer is still being determined as the industry continues to make adjustments. Regardless, the need for scalable solutions and technologies will remain paramount.

With the industry looking to streamline its manufacturing processes to become more cost-effective, what technologies do you have in your armoury to ensure you continue to remain competitive as the industry evolves?

JM. Corning Life Sciences places an emphasis on investment in R&D and product and technology innovation and also has a firm understanding of market and customer needs - three key components to helping pharmas compete and succeed in today's market environment. Corning's Life Sciences business brings to pharma companies a unique combination of core capabilities in materials, surfaces and biophotonics to deliver high value products for both research and drug discovery and development, including cell culture/cell scale-up technologies and high throughput label-free detection and screening. 

Most recently, Corning introduced the first synthetic surface, Synthema, for xeno-free growth of both primary cells and stem cells, and Corning also provides pharmas with a wide range of cell biology products, which allows for 'cells to assays' solutions - enabling growth and scale-up of cells for assays and protein expression. Corning has commercialised numerous technologies for scale-up and production including HYPERFlask Vessels, CellSTACK Culture Chambers and CellCube Systems. Corning also offers a full line of 96, 384 and 1536 well microplates for assays, storage, drug transport and protein crystallography. 

Additionally, its Epic technology provides pharmas with a leading high throughput label free detection system. Corning continues to advance its position in label-free detection by providing protocols for biochemical and cell-based assays as well as providing enabling methodologies for drug repositioning and early toxicology profiling.

LM. Bachem is a specialist supplier for complex substances and challenging synthetic molecules. We are particularly strong with hard-to-make products with very high quality requirements. This requires many years of know-how and many years of building a quality mentality and infrastructure. We often say at Bachem "quality matters" and it is a mindset that pervades everything we do and is reflected in everything we make. The combination of this and special technological expertise is already a very good differentiator.

Additionally, we have streamlined our internal processes, structures and investments to adjust for the period of weaker demand to ensure we still remain financially healthy. A mid-size and agile company can do this often better than some other types of organisation. Where we have however intensified our efforts and resources is in marketing and sales. In such a challenging market environment, it makes sense to maximise activities to fill the pipeline with new projects.

As pharma firms look to head into more complex compounds dealing with higher levels of unmet medical need, how does the dynamic change between yourselves and your clients - especially considering the need for open collaboration within the industry?

LM. The trend you mention is certainly taking place and is in fact very well aligned for Bachem. I have previously mentioned oncology as an example but there is also the same evident trend for anti-diabetics and anti-viral drugs. This alignment to peptides and other Bachem technologies is very positive. As we also serve the research ingredient market with our peptide catalogue and we observe the trends carefully here too in order to optimise our new product selections and our services. As an example, we recently added a very exciting new selection of fractionated venom lead-finding kits (Melusine) to our portfolio. We have already seen that this was much appreciated by our customers.

JM. In an industry where there is presently a lot of rapid change taking place, specifically regarding the complexity of research to meet advanced medical needs, one thing that is clear is that a one-size-fits-all approach will not work. The key will be close working relationships between pharmas and vendors based upon open and frequent dialogue that breaks down silos and drives product and technology innovation to meet researchers' needs and maximise results.

Where do you see the world of surface technology manufacturing heading in the next few years?

JM. Based on our existing relationships with many of the world's top pharma companies and our own 95-year heritage manufacturing leading technologies for the pharma and life sciences market, the future of surface technologies and manufacturing is moving more and more towards surfaces that enable close in vivo cell environments, synthetic surfaces that are scalable in formats, and xeno-free surfaces. Additionally, because research and the technologies that support it are progressing so rapidly, a solid understanding of both current technology and new technologies will be paramount - this further emphasises the need for open, close, working relationships to ensure emerging needs and the rate of innovation are in lock-step.

LM. Specifically for our business, the development of special resins will always be important for the manufacture of peptides. Solid phase peptide synthesis will continue to dominate as a technology versus older, conventional solution phase technologies, as more complicated peptides require the use of this preferred methodology. Additionally, for simpler cost-sensitive structures, micro-reactor technology is clearly having an impact. So the technology will follow the market needs both on the need to produce more complicated structures but also to reduce costs at the same time.

This is actually a very exciting time on the pharmaceutical research front where some newer drugs are emerging to break though the long impenetrable therapeutic barriers related to cancer. I am hopeful for much more medical progress in this field in the coming years. If further improvements can be made in drug delivery systems as well as reducing the cost to produce these complex molecules, we can all be part of something great!

About

Lester Mills is currently Chief Marketing Officer with Bachem Holding AG. He studied chemistry at Cambridge University (UK), gained a PhD at the UEA (UK) and received an MBA from SUNY (US, 2001). His earlier career was in R&D with Lonza Ltd, Visp (1987) and later with Roche Vitamins Ltd as Sales Director.

Dr Jeffrey L Mooney is the Commercial Technology Director at Corning Life Sciences and is responsible for assessing and developing product concepts and technologies for genomics, proteomics, and advanced life sciences. Mooney has bachelors and masters degrees in biology from Gettysburg College and Villanova University respectively and a Master of Arts Doctorate in biology from Temple University. He has more than 50 patents and 15 publications relating to genes essential for growth, microarrays, high throughput cDNA cloning and sequencing.