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Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.
Since the beginning of the COVID-19 pandemic, providers offering contract testing services have seen various changes and improvements to everyday processes. According to Lara Silverman, PhD, founder and principal consultant at LIS BioConsulting, it became increasingly crucial for contract testing labs to provide seamless services to clients and communicate any issues in a quick, efficient fashion. Dana Cipriano, senior vice-president of Testing & Analytical Services at the Center for Breakthrough Medicines, seems to second this observation, sharing that she has seen contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.
Some other new processes that have occurred in the bioprocessing/testing services space include new analytical technologies for fast in-process controls during virus-like particle production, according to Nik Barbet, PhD, head of Operations at Vector BioPharma. At Eurofins BioPharma Product Testing, Stanley Prince, Director of Biosafety & Cell/Gene Therapy Strategy, says they are focused on investing in automation and alternative methods and technologies, such as the RNA-based BioFire rapid mycoplasma test. Additionally, a proprietary degenerate polymerase chain reaction platform used to offer services for rapid detection of adventitious contaminants (Blazar), as well as rapid sterility testing with an emphasis on services are emerging from MilliporeSigma, where the company is focused on adopting rapid molecular and genomic methods, according to Benoit Gourdier, head of Contract Testing Services at MilliporeSigma.
With these analytical testing services, bio/pharma companies are still benefitting in terms of cost savings and efficient development times. Outsourcing analytical testing to contract testing companies helps to reduce the cost of drug development by providing access to state-of-the-art equipment and expertise and reduces the time required for drug development, according to Cipriano.
Shailesh Vengurlekar, senior vice president, Quality & Regulatory Affairs at LGM Pharma, adds that a lot of small- or medium-sized companies do not have enough qualified lab chemists, space, or equipment to meet their internal need of analytical method development and validation.These companies compete directly with larger organizations for on-time product approval and market share. However, the expense of testing facilities and qualified staff, along with regulatory costs, can be outrageous. By contracting analytical services, these companies can redirect their core competencies to meet company goals on time.
Barbet, meanwhile, explains how emerging analytical technologies require highly specific expertise, skills, and occasionally equipment that are not always easy to establish internally. As a result, corresponding services that are contracted with recognized service organizations are needed to solve technically demanding tasks. It can take time to onboard and prepare an outside testing provider.
In terms of upcoming changes to testing services from contract development and manufacturing company/contract manufacturing company (CDMOs/CMOs); although there are shifts happening, it can take time to onboard and prepare an outside testing provider, according to Silverman. “Instead, if internal capabilities exist, that process could be streamlined and therefore reduce cost to the customer and overall timelines. Also, for cell therapy products, specifically, where lot sizes can be very small, some of the major providers of testing services are unfamiliar with how to manage small lot sizes, which can cause delays as the team defines a sampling strategy to meet existing internal qualifications of tests,” she says.
Increasing the testing services offered for biologics, including characterization and stability, adds value for customers, Vengurlekar says.
Stability testing has been and will continue to be required for all drug products, including biologics, and according to Gourdier, they will assess both drug substance and drug product for attributes, such as potency and degradation at long term and accelerated storage conditions, sensitivity to heat, light, and humidity, and freeze-thaw viability.
As for the future of contract testing services and their impact on the industry, people such as Barbet hope that services for transducing particle quantification or for genomic purity and vector integrity will boost the demand for external testing services, especially for gene therapies. Prince explains that many organizations are attempting to still follow the traditional compendial approaches and guidance documents that were intended for biologics, where volumes and product concentrations are not an issue. As this industry continues to grow, Vengurlekar believes that—as new technologies are introduced—CDMOs can embrace the change and adopt these shifts into their service line offerings.
Silverman highlights how important contract testing services are to the industry in helping enable drug developers to bring novel products to patients. She hopes that contract testing labs are prepared to understand new modalities and provide meaningful technical insight and regulatory advice to cutting-edge companies. “Following approvals, testing laboratories must be ready to support the potential high volumes and fast turn-around times during commercial use, which means building a strong relationship with the drug developer and preparing capabilities to support product release in a timely manner. For some patients, these products are lifesaving and delays are simply unacceptable,” she asserts.
Jill Murphy is an Editor at Pharmaceutical Technology.
Volume 47, No.4
When referring to this article, please cite it as Murphy, J. Combatting Testing Services Solidify Their Place in the Manufacturing Value Chain. Pharmaceutical Technology 47 (4) 2023.