Today’s modern biopharmaceutical lab must operate in a complex and ever-changing regulatory environment. The stringent rules applied to the drug development process demand that meticulous records be maintained and that quality assurance (QA) and quality compliance (QC) are demonstrated to the highest level.
1. Organizational Streamlining
In the past, the organizational structure of large pharmaceutical companies, collectively referred to as “Big Pharma”, typically resulted in a “silo-based” approach, where functional units within an organization frequently worked independently from one another. This led to a situation where communication was often poor between departments, resulting in insufficient coordination and unnecessary duplication of effort. The management structure in these organizations tended to be run from the top-down, with many hierarchical levels of bureaucracy, and high numbers of staff. This meant that decisions could take a long time to be implemented and that adapting to changing market conditions was difficult, due to the fragmented nature of this type of organizational structure. In recent years modern biopharmaceutical labs have begun to adopt an increasingly agile and adaptable organizational structure, more akin to that seen in biotechnology startup companies.
This organizational streamlining in biopharmaceutical labs has seen the emergence of more team-oriented, matrix-driven management structures, with smaller employee numbers, leading to a more efficient drug development process overall.
2. Streamlining the Biopharmaceutical Lab Workspace
An important consideration to take into account when streamlining a biopharmaceutical lab is the workspace itself. The physical and logistical aspects of the lab workspace should be reevaluated to ensure streamlining of processes and people, and to promote maximum efficiency at all levels of the drug development pipeline. Techniques can be employed to organize the workspace in such a way that wasteful movement, space, and supplies are eliminated or minimized to as great an extent as possible. For example, the specimen storage and handling process can be automated to a large degree to reduce human errors. Equipment can be arranged and positioned so that laboratory staff can access it as efficiently as possible. Streamlining your workspace in this way can both reduce costs and increase efficiencies throughout your drug development process.
3. Standardization
Standardizing equipment, supplies, processes, protocols, and reporting tools can streamline your pharmaceuticals development process. The use of standardization can provide several efficiency gains in drug development operations. Standardization enables a biopharmaceutical lab to benefit from the economies of scale that can be leveraged when purchasing reagents or equipment. Standardization also affords flexibility among the workforce – when SOPs are used wherever possible throughout a production operation, an employee trained in one procedure or protocol can easily take over another step in the manufacturing process, as and when they are needed to do so. Standardization will also clearly have streamlining benefits in your validation processes, reporting requirements, and quality assurance and control.
4. Laboratory Information Management Systems
Laboratory information management systems (LIMS) have been used to assist in biopharmaceutical research and manufacturing for many years. Initially, the use of LIMS in drug development was relatively unsophisticated and was limited mainly to the storage of completed data. However, as the regulatory environment for pharmaceuticals companies has evolved, so too has the IT designed to support the industry, and nowadays many LIMS offer you a wide variety of functions that can help to streamline many different laboratory processes. For example, LIMS can assist in operational processes, such as inventory, dispensing, and weighing. Other features offered by LIMS include the generation of electronic QA/QC compliance and validation reports. LIMS can provide real-time data relating to various aspects of drug development and manufacture, as well as monitoring processes and products, providing detailed information about ambient laboratory conditions, and controlling routine operations. Real-time diagnostics of manufacturing processes can alert staff members to any potential production problems promptly. This allows corrective action to be taken immediately and avoids any unnecessary delays in your biopharmaceutical lab production line.
5. Integrated Biopharmaceutical Lab Solutions
Integrated solutions can now provide today’s biopharmaceutical lab with streamlined drug development processes that can enable or enhance many of the approaches outlined above. XiltriX, for example, offers you a comprehensive, automated monitoring and reporting system that can save your busy biopharmaceuticals company many staff hours per week by providing a single, comprehensive streamlining solution. XiltriX can be painlessly transitioned into your existing drug development workflow since it is an easily implementable system, which comes with 24-hour support and diagnostic services.
XiltriX offers several useful features for the modern biopharmaceutical lab and the regulatory environment in which you operate. The system incorporates a seamless means of recording and monitoring all of your facility’s data, including ambient variables such as temperature and pressure, as well as monitoring door opening and closing, deviations from set points, or any other anomalies that may arise. XiltriX also allows close monitoring of standard operating procedures, which means that even in the largest company, real-time data are available to ensure that personnel are following all methodologies correctly at all times. Measurements are made at a minimum of every minute, pinging every second in the event of an alarm. The XiltriX system affords you a straightforward way in which to store data and maintain regulatory standards, while simultaneously simplifying your reporting system and automatically creating validation reports, streamlining your overall reporting and regulatory process.
Summary
The modern biopharmaceutical lab must maintain an extremely high standard of regulatory adherence, while keeping track of multiple variables throughout the drug development process, from the supply chain, through processing, quality assurance, and control, and ultimately to the finished pharmaceutical product. Drug development is an expensive and time-consuming endeavor and presents the modern biopharmaceutical lab with a number of challenges. As outlined above, streamlining offers you a way with which to address some of these challenges, and a variety of tools now exist to help you in this process.
Learn more on how to maintain compliance, data integrity, and lab safety in our white paper:
