Efficiency is more than just a buzzword in today's pharmaceutical industry; declining productivity and diminishing returns on investment have made it an over-arching mindset that is critical to corporate survival. Low-tech strategies to maximize efficiency may include streamlining existing protocols and relieving bottlenecks, but, undoubtedly, the most direct and effective approach to improving process efficiency and overall productivity is to operate 'lean and mean' — to maximize time, labour and resource utilization while simultaneously optimizing the speed and quality of data acquisition — ultimately moving projects through the pipeline more quickly and with greater success. Employing miniaturization and automation solutions to replace processes that consume substantial quantities of high-value resources and rely on labour-intensive manual operations will not only improve the efficiency of critical steps along the drug discovery continuum, but also help increase overall productivity by ensuring robust and reproducible operations.

Figure 1: Correlation between Biacore and Gyrolab results in lgG-containing harvest.

Miniaturization and automation technologies have particular advantages and applicability for assay development and high-throughput assay performance. There are many benefits to being able to perform automated assays at the nanoliter scale; for example, smaller volumes mean less sample is needed per assay, allowing companies to perform more assays and gain more information from limited starting materials. This also reduces the amount of reagents and buffers required, translating to smaller quantities of materials that companies have to purchase, dispose of and store. From an efficiency perspective, the most important aspects of assay miniaturization are the reduced time for assay development and the shorter cycle times, enabling more timely decision-making and helping companies move projects forward more rapidly (Figure 1).

Figure 2: High intra-run reproducibility.

Adding automation and robotics technology to miniaturized platforms further enhances the speed of processing and also introduces other advantages. Automation eliminates the variation and risk of error associated with manual operations, thereby improving data quality (Figure 2). Importantly, by standardizing operations and procedures, automation facilitates the transfer of processes both within a drug discovery organization and between a company and its outsourcing partners. Validated assays performed on readily available instrumentation are particularly attractive to the rapidly expanding CRO and CMO industry. Not only do contract service providers place a premium on cost-effectiveness, efficiency and productivity, they also prefer technology solutions that minimize manpower needs.

Downsizing immunoassays

On the go...

Biologicals, including protein-based therapeutics and, in particular, monoclonal antibodies, are enjoying a resurgence of interest in the pharmaceutical industry, and this trend is likely to continue. Companies are under intense pressure to identify promising protein therapeutics quickly, to fail unsafe or unsuitable drug candidates early on in the process, and to generate as much information as possible regarding safety and efficacy during the discovery and preclinical stages of product development before taking a drug candidate into the clinical phase. Coupled with these pressures is an industry-wide emphasis on cutting costs, preserving limited resources and minimizing the numbers of animals required for preclinical testing. To meet this last goal, efforts have focused on the development of innovative, high-throughput assays that generate data that can predict a compound's metabolic, toxic and pharmacokinetic (PK) properties.