The discovery of suitable lead structures for new drugs from an inexhaustibly large reservoir of theoretically possible compounds is one of the biggest challenges for the pharmaceutical industry. In the last few years, combinatorial chemistry methods have been developed to synthesize a huge amount of diverse new chemical entities (NCEs), which may subsequently be tested for biological activity in vitro.
The latest generation of HPLC instruments offers a new level of data security. Improvements in embedded instrument control programs and mass storage functionality offer 'no data loss' guarantee. This level 5 instrument control makes data acquisition audit-safe and increases laboratory technicians' efficiency, freeing them up from any reanalysis work.
Creation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
The pharmaceutical sector is a billion dollar industry with a huge responsibility towards its customers and investors. The main tools for fulfilment of this responsibility are ensurance of compliance and maintenance of control. It is a time-consuming job to uphold these responsibilities, and many important decisions regarding this subject are taken every day. It is important to make carefully considered decisions and follow them up. It is also essential to stop once in a while and reconsider their validity and relevance.