Navigating the Preclinical CRO Outsourcing Process

To reduce costs and streamline their internal processes, bio/pharmaceutical and biotech companies are increasingly outsourcing many of their internal operations related to the development of their therapeutic compounds, including preclinical testing. That said, contract research organizations (CROs) are playing a more important role in providing critical testing services required for internal validation purposes and submission to regulatory agencies. Navigating the preclinical testing process can be a somewhat confusing, if not difficult, task including identifying the proper partner for conducting the necessary studies to help advance a promising lead compound from the discovery phase to the initiation of investigational new drug (IND) process.

This article will serve as a useful guide, including why/when to outsource preclinical testing, the advantages and disadvantages of outsourcing this testing, and how to effectively choose a partner to conduct this testing.

Why outsource preclinical testing?

With the ever-growing complexity of pharmaceutical therapeutic development, it is becoming more and more difficult for companies, both small start-ups and even large global entities, to maintain all the relevant capabilities internally required for full development of promising lead compounds to the initiation of the clinical testing phase. Academic institutions often collaborate with companies on early stage R&D with later-stage testing and manufacturing being outsourced to CROs and contract manufacturing organizations (CMOs).

The following are some of the reasons why outsourcing is becoming more and more prevalent in pharmaceutical development (1):

• increased flexibility to pivot research and development focus
• reduced personnel and facilities costs to companies
• leveraging of CRO’s specific technologies and expertise in study design and execution, project management, and quality assurance
• non-bias and independent validation of initial results obtained at companies’ facilities.

Preclinical CROs fill this need as they often provide these specialized platforms and expertise to assist companies to successfully push their products through the R&D to IND process, ultimately resulting in clinical testing required for entry into the market. From in vivo, in vitro, and analytical/bioanalytical services, subcontracted organizations can provide turnkey solutions to these companies that may lack internal facilities, instrumentation, knowledge, and quality systems to successfully execute the necessary studies to assess their target compound’s efficacy and toxicity. For instance, the costs to construct, manage, and maintain in-vivo facilities may be prohibitive for companies, especially for small start-ups with limited capital. Even larger companies, which have traditionally maintained these types of capabilities internally, are downsizing their internal in-vivo capabilities due to the ever-increasing regulatory burden and the ever-increasing costs required to staff and maintain these facilities. A CRO with this specific expertise and appropriate facilities can easily execute these types of studies at relatively low cost with a well-trained professional team overseeing all aspects of the study, ensuring a high-quality efficacious project.

Read the article in the Partnerships for Outsourcing eBook.

About the author

Daniel Radiloff, PhD, is director of Business Development, Pacific BioLabs.

Article details

BioPharm International®
Partnerships for Outsourcing eBook
May 2024
Pages: 4-7

Citation

When referring to this article, please cite it as Radiloff, D. Leveraging Blow-Fill-Seal Technology for Biologic Delivery. BioPharm International Partnerships for Outsourcing eBook, May 2024.