Immunoassay services are crucial for drug development. During preclinical and clinical research, sponsors may outsource several responsibilities to assay development services. The primary reasons for outsourcing analytical assay development are targeted expertise and cost-effectiveness. Assay development and validation approaches are unique for individual analytes of interest. Bioanalytical assay service providers have existing frameworks to perform bioanalytical testing without sponsors needing to invest in equipment and infrastructure. 

Partnering with assay development services has provided flexibility to sponsors and drug developers. This flourishment is evident in an increase in companies offering assay development services. However, sponsors must consider several factors before partnering with assay development services. The current article shares tips for successful partnerships. 

Factors to consider while partnering with assay development services

Assay development services are an extension of the drug developer laboratory and sponsors. Hence, they should have expertise in the therapeutic area of interest. An ideal assay development service provider will have a proven track record and expertise similar to the required project. Ideally, assay development service providers offer all related solutions under one umbrella. However, sponsors should have a thorough conversation to ensure the partner laboratory fulfills all their expectations. 

Preclinical testing requires GLP and FDA complaints. An ideal assay development service provider should be GLP and GCP-compliant. The partner laboratory should have quality systems for documenting procedures and processes and responsibilities for fulfilling regulatory and customer requirements. Identify the assay development service provider’s quality systems. Look for specific certificates, and if they are missing, ask how the laboratory can assure quality for their assay development services. 

Timely and high-quality data is critical for making the right decisions. Paper-based protocols can be inefficient. Hence, assay development service providers should have the technology for data handling and management. However, digital solutions face unique challenges. Therefore, sponsors should evaluate the laboratory's ability to organize and share data. Understanding the capacity to maintain confidentiality in identifying electronic data capture systems, regulatory compliance for electronic signatures and records, data security and integrity, and other data handling considerations remains crucial for meeting data-sharing expectations.

Opt for a flexible assay development services provider. Clinical research is a challenging endeavor and requires flexible and expert lab partners. Changes in priorities and shifts in focus are inevitable in drug development. Hence, assay service partners should be flexible enough to navigate through these hurdles while meeting expected timelines without undue delays. Notably, sponsors should ensure that their partner laboratories have sufficient resources to complete their project and overcome any unexpected delays. 

Laboratory oversight is critical for sponsors. Regular communications can help sponsors keep track of experimental progress and ensure that their laboratory partner is performing tasks as intended. A robust escalation process is critical to fill any gaps. Escalation processes are vital for resolving issues and enhancing the overall assay development process. Different problems will arise depending on the risk factors involved in a particular assay development project. However, timely deployment of escalation processes can help drug developers resolve issues and tackle them head-on. 

In conclusion, assay development services are critical for accelerating drug development studies. However, sponsors should take adequate care to maximize the value of assay development services. 

Must Read: The Role of ELISA Services in Drug Discovery and Development: A Critical Component of the Pipeline