Accurate and reliable bioanalytical services play a critical role in innovators’ decision-making and the success of pharmaceutical products. Working with a bioanalytical CRO that offers comprehensive bioanalytical services and can support the entire product lifecycle from late discovery through commercialization provides strategic advantages through streamlined processes, continuity, efficiency, faster time to market, cost reduction, and regulatory compliance.
To streamline the development process, a bioanalytical CRO with fully integrated capabilities will apply its extensive expertise to the biopharmaceutical candidate, determining which assays are necessary to assess and demonstrate critical quality attributes.
Assays created for research and development must meet high-level standards before being suitable for biomanufacturing, product testing, or product release. The need for enhanced robustness requires investigation of the methods to prove effectiveness across the full range of conditions that might be experienced concerning a drug’s concentration and its biological activity. When a therapeutic advances to Phase II or Phase III clinical trials, methods used to evaluate drug candidates must be validated. Because many clients want qualification and validation of methods well before a candidate moves from development to the clinic, an ideal bioanalytical CRO will have established methods and a successful track record for achieving method and qualification milestones.
The Advantages of Turnkey Bioanalytical Services
Partnering with a bioanalytical CRO that offers integrated bioanalytical services capabilities to support the full lifecycle of a product offers numerous advantages, from seamless transitions between development phases to enhanced efficiency, expertise, and regulatory support. Key benefits include:
Seamless Continuity Across Development Phases
A CRO that covers the entire product lifecycle offers a seamless transition between different development phases. From early-stage research to preclinical and clinical trials, having consistent bioanalytical laboratory services support ensures continuity and consistency in data generation, reducing potential delays, miscommunications, and compatibility issues. It facilitates a more cohesive and coordinated approach to drug development, from early-stage pharmacokinetics (PK) and pharmacodynamics (PD) studies to late-stage clinical trials and regulatory submissions.
To allow a drug to advance efficiently throughout its phases of development, Prolytix cross-trains its team. Through this cross-training, the full Prolytix team becomes therapeutic candidate experts and can much more efficiently and effectively address the needs of the drug as it moves through its phases of development.
Enhanced Efficiency and Time Savings
Integrated bioanalytical services enable a more efficient use of time and resources. Rather than coordinating with multiple vendors, managing contracts, and ensuring data compatibility, partnering with a single bioanalytical CRO simplifies the process, allowing teams to focus more on core research activities. This translates to significant time savings, accelerating the pace of development and potentially speeding up time-to-market.
Enhanced Expertise and Innovation
A CRO that offers integrated bioanalytical capabilities provides access to a wide range of specialized expertise under one roof. Bioanalytical CROs employ state-of-the-art technologies and methodologies that deliver high-quality data and foster innovation in the development process. Integrated bioanalytical service providers can offer novel analytical approaches and tailor-made solutions that address the unique challenges of each drug development project, from biomarker discovery and validation to complex bioanalytical method development and validation.
Regulatory Compliance and Quality Assurance
Bioanalytical data plays a critical role in the regulatory approval process. A bioanalytical CRO with expertise in regulatory affairs can provide comprehensive support, ensuring all data generated meets regulatory standards. This comprehensive understanding of regulatory requirements and rigorous quality control measures minimizes the risk of compliance issues that could delay development timelines or impact the success of regulatory submissions.
Cost-Effectiveness
By using a qualified, single bioanalytical CRO, pharmaceutical companies can streamline the drug development process and potentially lower the overall cost of development.
A Bioanalytical CRO That Supports the Full Product Life Cycle
Prolytix leverages 35+ years of protein chemistry experience to support the large-molecule drug product lifecycle from discovery through release. Prolytix leverages its vast protein chemistry expertise, skilled project management team, and agile, consultative approach to deliver an average of 100% on-time delivery and high-quality data to streamline decision-making.
Prolytix can accelerate and de-risk a drug development program through bioanalytical testing for product development, analytical characterization to support chemistry, manufacturing, and control (CMC), method development and validation, GMP stability testing, or GMP release testing.
Prolytix’s GLP, GCLP, and CLIA facilities, plus 35+ years of experience developing and conducting critical bioanalytical testing services, swiftly and safely advance large-molecule drug products to market.