Contract Testing Services Show Improvement in Speed and Efficiency
The COVID-19 pandemic brought to light the importance of seamless contract testing services for both providers and clients. In addition to increasing speed and efficiency through new testing methods and technologies, contract testing labs must ensure quick and effective communication with clients.
Nik Barbet, head of Operations at Vector BioPharma, explains that new analytical technologies are being developed for fast in-process controls during virus-like particle production. Eurofins BioPharma Product Testing is investing in automation and alternative methods and technologies, such as the RNA-based BioFire rapid mycoplasma test, while MilliporeSigma is focusing on rapid molecular and genomic methods for rapid detection of adventitious contaminants and sterility testing.
Outsourcing analytical testing to contract testing companies offers cost savings and efficient development times, reducing the time required for drug development. Many small or medium-sized companies lack the necessary qualified lab chemists, space or equipment to meet their internal needs of analytical method development and validation. As such, contracting analytical services offers a solution to compete with larger organizations for on-time product approval and market share. Emerging analytical technologies require highly specific expertise, skills, and occasionally equipment that are not always easy to establish internally, and correspondingly contracted services with recognized service organizations are needed to solve technically demanding tasks.
While shifts are occurring in testing services from contract development and manufacturing companies (CDMOs) and contract manufacturing companies (CMOs), the process of onboarding and preparing outside testing providers can be time-consuming. If internal capabilities exist, this process could be streamlined, reducing costs to the customer and overall timelines. For cell therapy products, lot sizes can be very small, and as major providers of testing services are unfamiliar with how to manage such small lot sizes, delays in defining a sampling strategy to meet existing internal qualifications of tests can occur. Increasing the testing services offered for biologics, including characterization and stability, adds value for customers.
The future of contract testing services and their impact on the industry is promising. Services for transducing particle quantification or for genomic purity and vector integrity may boost the demand for external testing services, especially for gene therapies. As the industry continues to grow, new technologies can be embraced by CDMOs, adopting these shifts into their service line offerings.
Contract testing services are essential in enabling drug developers to bring novel products to patients. These services offer valuable technical insight and regulatory advice, and testing laboratories must be prepared to support potential high volumes and fast turn-around times during commercial use. A strong relationship with the drug developer is essential, including preparing capabilities to support product release in a timely manner. For some patients, these life-saving products offer no room for delays.
In conclusion, the contract testing services industry is dynamically responding to the emerging needs of clients through modernized and innovative approaches to testing. By adopting new analytical technologies and providing quality and regulatory services, they can ensure efficient development times, cost savings, and streamlined communication with clients. With ongoing improvements and growth, contract testing services demonstrate a commitment to partnering with the industry to offer high-quality, lifesaving products for patients.
