Industry Focus 2008

Genomics for the new biomedicine

Industry Focus 2008 / 7 April 2008 /

One of the most profound advances in biology and medicine has been the sequencing of entire genomes, including the human genome. The end product was the availability of the complete genetic blue print of organisms of importance to medicine and biotechnology. This changed how we conducted science. Cloning individual genes was no longer a limiting factor. Instead, entire scientific communities set upon understanding how genes interact with each other in pathways and across pathways so as to explain complex biological and physiological processes. For the biotechnology and pharmaceutical industries, the identification, cloning, and engineering of a single gene to produce a key biological product such as erythropoietin, was no longer an attractive investment prospect. Instead, companies that produced either a clinically tested end-product, or provided entire platforms for high throughput screening, were the only ones being funded. The new benchmark for success is now speed and comprehensiveness, which are orders of magnitude greater than just ten years ago. (more…)

Tagged with: Biomedicine, Edison T. Lium, Genome Institute of Singapore, Genomics

Mass spectrometry based proteomics: trends in tools and strategies

Industry Focus 2008 / 7 April 2008 /

Recent years have seen great upward leaps in the development of mass spectrometry applied to the field of proteomics. Today it is possible to take a complex biological sample such as organelles, cells, tissue or a biofluid, perturbed or stimulated in some way, and identify and quantitate up to several thousand proteins and determine the level of relative change caused by the perturbation or stimulus. The current challenge is not to identify or quantitate proteins in a limited set of samples, but to profile large series (clinical samples, time-course, sub-cellular compartments) at sufficient depth, and to interpret and make biological sense of the data.

At the end of the 1980s, we saw the birth of two new ionization techniques that changed the face of mass spectrometry; electrospray ionization (ESI) and matrix-assisted laser desorption ionization (MALDI). In the 2000s we have seen terrific developments in mass spectrometer design, such as the development of hybrid fourier-transform, the MALDI-TOF/TOF and hybrid triple quadrupole-iontrap (QTrap) mass spectrometers, and recently an entirely new mass analyser, the orbital electrostatic trap that became incorporated in a hybrid platform with an ion trap (Orbitrap)1 (Figure 1). This new instrument allows for great sensitivity, mass accuracy and high-throughput MS/MS. Combined with the new fragmentation technique ‘Electron Transfer Dissociation’, that preserves labile PTMs great advances are expected in the field of signaling research. (more…)

Tagged with: Connie R. Jimenez, Mass spectrometry, OncoProteomics Laboratory, Proteomics, VUmc Cancer Center

Quo vadis, Laboratory Automation Education?

Industry Focus 2008 / 7 April 2008 /

The increasing need for improved efficiency, precision and 24/7 operation imply more and more sophisticated measures in laboratory automation. This is true for a variety of fields – from pharmaceutical to food, agricultural, and the petrochemical industry, as well as forensics and medical diagnostics. Chemical and biological tests have to be supported by very small individual samples in medicine and forensics, up to continuous flow production with inline quality control in the chemical industry. A vast variety of physical, chemical, and biological methods need to be supported by experiment design and control, data acquisition and evaluation, documentation as well as simulation. Time constraints, high performance, extensive resource utilisation, and reproducibility of results demand a high degree of automation including unmanned operation. Global collaborations within multinational companies are the order of the day. Regulatory compliance with its diversity of validation processes increases the complexity of tasks. In addition, laboratory automation is no longer limited to R&D or production laboratories; it is now totally integrated into almost all production systems in a globalised enterprise. Adequate automation solutions always need the expertise of domain experts and automation specialists. (more…)

Tagged with: Dr. Reinhold Schäfer, Lab Automation

QbD and PAT – 2008 is the year it goes mainstream

Industry Focus 2008 / 7 April 2008 /

Since the FDA revolutionary white papers[1,2] in 2004, the industry has talked non-stop about the potential of PAT (Process Analytical Technology) and more recently, QbD (Quality by Design). These topics have found regular spots in conferences, press and internal company discussions. It has been widely stated3 that the benefits are potentially huge and that this way of developing and manufacturing life science products offers the opportunity to ‘catch up’ with other industries such as food and electronics, which have their processes down to a ‘science’ rather than an ‘art’.

Despite these touted advantages, the take up of the tools and technology has been relatively slow. Yes, submissions, under the new framework are starting to arrive, but it has been surprising to see the slow conversion with the theoretical amount of financial savings on offer. The reasons for this slow uptake are complex and will be discussed shortly. The prominent thing to note is that, until 2007, there was still a lot of discussion of ‘why to’ or ‘how to’ pursue PAT and QbD initiatives. (more…)

Tagged with: Alex Brindle, NNE Pharma Plan, PAT, Quality by Design (QbD)

Pharmaceutical analysis in quality control

Industry Focus 2008 / 7 April 2008 /

Pharmaceutical analysis in drug development mainly focuses on methods to identify and quantify potential new drug candidates, determine purity, identify by – products and degradation products in compatibility and stability studies, and to determine the drug substance’s fate in the organism. Challenging tasks like these require sophisticated techniques, dedicated equipment and methods operated by highly skilled staff, often with a good academic background.

The challenges that have to be faced in pharmaceutical quality control are different – techniques and methods must be well established and recognised. Robustness, not brilliance is the main feature to be accomplished by laboratories running under time and cost pressure using routine equipment operated by varying levels of experienced staff.

Accordingly, a review and the subsequent assessment of the developments in pharmaceutical analysis will generate different results when performed under this perspective. (more…)

Tagged with: Analytical techniques, Bernd Renger, Quality Control, Vetter Pharma-Fertigung GmbH & Co. KG

CROs as a strategic fit – the one stop shop for R&D services

Industry Focus 2008 / 7 April 2008 /

Contract Research Organisations (CROs) provide independent development services for pharma, biotechnology, and medical device markets. Services offered by CROs have evolved from providing basic support, to a wide range of services catering to various needs of the market and the sponsors. The United States is the world’s largest market for drugs and accounts for almost half of the research and development (R&D) spending in pharmaceutical and biotechnology markets. Hence, CROs have a strong presence in this market and have invested in new facilities and technologies to cater to a wide range of sponsors. It is estimated that only 25 percent of the R&D activity is currently being outsourced to these organisations. This is likely to double in the coming years due to mounting pressure on the pharmaceutical companies to increase productivity of the cost intensive drug development process.

In recent years, the portfolio of services offered by CROs has widened dramatically, with many CROs becoming a one stop shop (full service providers) offering an exhaustive list of core and ancillary R&D services. A majority of these overlap on pharmaceutical R&D enabling technologies, using proprietary techniques which include; genomics and proteomics, high throughput screening, combinatorial chemistry and many others. With the high level of merger and acquisition activity in the pharmaceutical industry and with larger companies using greater ‘downsizing’ strategies to concentrate resources on their core competencies, CROs are having to add extra capabilities to their menu of service offerings as a route to sustaining revenue growth. This broadening of CRO services is also leading to an increased availability of expert personnel. With a wider portfolio of services, many CROs now regard themselves as strategic partners of pharmaceutical clients rather than simple service providers or vendors. However, a large proportion of companies continue to view these contractors as specialists in discrete and niche areas. (more…)

Tagged with: Contract Research Organisations (CROs), Frost and Sullivan, Research & Development (R&D), V. Sriram