Bigger isn’t always better: The value of scalable solutions in today’s pharma market

By By Dr. Jeffrey L. Mooney, Commercial Technology Director, Corning Life Sciences

Coming down from a long period of sustained growth, the pharmaceutical industry is now feeling the effects of reduced spending during the recession, more stringent government regulations and heightened competitive pressures, both from generics and from the healthcare industry. According to industry research, the impending 2011 “patent cliff” is set to erode $78 billion in global branded sales from drugs facing patent expiry plus $32 billion from continued erosion of already expired brands. Add to that the fact that, with a few exceptions, the pace of blockbuster drugs hitting the market has slowed considerably and the pipelines are drying up. To maintain profitability in the face of slowing sales to 2014, pharma companies have implemented a number of cost-cutting measures as well as strategic repositioning and diversification strategies to boost profitability going forward.

While pharmaceutical companies need to not only bring drugs to market faster, do so more efficiently (and effectively), and be continually cognizant of quality, 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 utilizing 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 minimizing costs, improving results, and decreasing the effects of biological influences.

Disposable and scalable bioreactors provide pharmas with the ability to scale process design and implementation without the worry of contamination that can result from reusable consumables. Synthetic surface technologies enable researchers to avoid the need to account for and prove potential biological influences with biological surfaces-they are not limited by biological by-products nor do they have lot-to-lot variability. Based on what pharmas are trying to accomplish in today's environment, the perfect blend is using synthetic scalable surfaces potentially on beads in disposable bioreactors.

This will all be particularly important as stem cell research continues to advance. Many clinical trials today are using 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. 

Another avenue being taken by today's pharma companies is the use of Contract Manufacturing Organizations (CMO) to meet economic cost targets.  Outsourcing to a CMO allows pharmas to better manage internal resources and costs by focusing on core competencies and high-value projects while reducing infrastructure or technical staff. 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.  

To better assist pharmas in today's changing landscape, some of the major suppliers and vendors are now developing and delivering products and technologies that enable pharmas to meet the increasing need for more efficiency and capacity in research, scale-up and production. There have been a number of scalable innovative solutions brought to market in the past 12 months such as synthetic surfaces, advancements in high throughput label free detection technologies and disposable bioreactors.  

Corning Life Sciences, for example, is one such vendor that places an emphasis on investment in R&D, product and technology innovation as well as having a firm understanding of market and customer needs. 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, Synthemax, 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 commercialized 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.

The decisions made by today's pharma companies will be driven not only by the external market factors and dynamics but also internal considerations tied directly to their own pipelines, processes, and anticipated needs.  As these decisions are made it will be important for companies to closely align themselves with partners and vendors that understand the challenges and work with pharmas to bring to market products and technologies that closely align with their objectives.  

About

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