Timely bioanalytical support is required during the drug development and discovery process to make rapid and well-thought-out decisions. Upgraded and updated bioanalytical laboratories are crucial for the optimization of the drug discovery process. In recent years, bioanalytical labs are constantly facing pressure to cut costs and increase their efficiency due to the tremendous workload in the pharmaceutical industry and to compete with other bioanalytical labs and bioanalytical CROs in the market. Maintaining high-quality data is the first priority while reducing operational costs. 

The Purpose:

The purpose of optimizing production and operational costs while maintaining quality should be to obtain a laboratory that:

  • Is Responsive to present and future requirements
  • Recruits qualified scientists
  • Encourage the collaboration of scientists from different fields
  • Facilitate cooperation between all the development partners of the drug

The Key Elements:

Bioanalytical processes are complex and must be precise to get the perfect results. A range of technologies is used which include instrumentation, intelligent robotics, and powerful computers and software. The four major elements of the bioanalytical laboratory to function successfully are:

  • Facility
  • Infrastructure
  • Compliance
  • Documentation

Facility:

For a well-organized bioanalytical facility, sufficient clean space is important. The facility should have:

  • Efficient placement of instruments
  • The proper location for sample preparation
  • The smooth flow between various tasks
  • Proper areas for non-laboratory and paperwork.
  • Efficient location of communication instruments (phone, computer)
  • Effective communication between personnel
  • Proper ventilation of the facility
  • Security against unauthorized access
  • Validation of software and instruments used 
  • Proper personal protective equipment (PPE) kits for safety

Infrastructure:

All laboratory personnel must have proper qualifications and experience. A proper management structure should be in place to oversee all the undergoing adequately. A laboratory should contain organization charts consisting of current personnel and reporting relationships. Typically the chart is in the hierarchical format from top to bottom but it can also be in the form of a list. A lab needs different personnel to fill all the required roles like:

  • Validation scientist
  • Sample analysis scientist
  • Sample management
  • Contributing scientist
  • Principle Investigator 

Smaller organizations combine various roles into one to improve efficiency. Proper training should be provided from time to time regarding the new developments. 

Compliance:

When you are working in pharmaceuticals that deal with drug discovery and development, there are regulations and rules that must be kept in mind and followed thoroughly f you want the drug to be approved by FDA. so, compliance with all the rules in place is an integral part of a bioanalytical laboratory. Two important areas that need compliance are

  • Industrial regulations
  • Standard operating procedures

The work done in laboratories is sensitive and the “behind the scenes” work should be completed according to the book if you want the product to appear in the market. 

Documentation:

All the data obtained during the work should be documented properly i-e what was done? How was it done? Where was it done? Who did it and when? All documentation should be done in real-time so that the data can be regenerated easily. Bound books or loose-leaf binders can be used for documentation of lab work. If an electronic notebook is used, it should also be saved in the cloud to remove the risk of deletion. Any deviation from the SOPs during the procedure should also be documented.