Fast Forward in Pharma: GMP-Compliant CROs Driving Swift Biologics Market Entry

How do biopharmaceutical companies fast-track groundbreaking biologics to market? The answer is Contract Research Organizations (CROs), the secret engines powering innovation, compliance, and speed in biologics development. In this blog, we talk to the CRO BioOutsource about how they help their clients bring life-saving biologics across the finish line.

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The Pivotal Role of CRO Expertise

CROs bring a wealth of expertise to the biologics development process, filling vital gaps, mitigating risks, and speeding up the time to market. This is especially valuable to smaller biotech companies that lack the resources or infrastructure.

Regulatory compliance is one area where this kind of specialized support is invaluable. CROs help companies navigate the labyrinth of Good Manufacturing Practices (GMP) and other regulatory standards, ensuring alignment at every step.

We asked about biologics testing and the compliance challenge in our interview with Ben Tyrrell, Senior Scientist at BioOutsource (acquired by Sartorius in 2015), a CRO offering GMP-compliant cell bank manufacturing and testing services, including biosafety, analytical, sterility, and mycoplasma testing.

Can you explain how CROs like BioOutsource support biologics developers?

“Biologics testing and meeting commercial release standards is a complex challenge for drug developers. You need to identify the best testing strategy for your molecule and have access to GMP-compliant labs that uphold stringent quality requirements. We provide these resources to help our clients get the necessary data for drug approval. Our spectrum of assays includes both ready-to-use and custom-developed options that really streamline the journey from lab to market.”

What are the challenges in developing assays for biologics testing?

“Developing assays for biologics testing requires a methodical approach, from proof of concept to qualification. The challenge of creating these assays in-house is compounded by the need for advanced analytical technologies for molecule and cell analysis, like LC-MS, live-cell imaging, and high-throughput flow cytometry, and their integration into a GMP-compliant workflow. As you can imagine, implementing this infrastructure quickly is not possible for a company just starting out.”

How about complex assays? How do they fit in cGMP biologics workflows?

“Complex assays, such as Antibody-Dependent Cellular Phagocytosis (ADCP) give you crucial information on a biologic’s efficacy and mechanism of action. However, conducting these assays to GMP standards is a limitation for some. You need more sophisticated instrument capabilities along with extensive resources for full system integration and documentation. Ensuring GMP compliance also involves detailed installation and operational qualifications (IQ/OQ) as well as specialized compliance-supporting software. This is where CROs bring tremendous value.”

How do you make sure that your processes comply with regulatory requirements?

“A fully compliant workflow has to be built from the ground up and can only happen with deep expertise. You need a dedicated Quality Department and comprehensive training on critical aspects like traceability and environmental controls. Additionally, integrating digital systems like LIMS into workflows is essential for sustaining compliance, yet it introduces difficulties in both adoption and ongoing management. For us, this is our bread and butter, so we can help alleviate this stress entirely.”

On that note, what does it take to achieve GMP release of an instrument?

“To get GMP clearance for an instrument you need traceability and data integrity. Traceability means a tamper-proof audit trail, specific user access levels, and digital confirmations for activities. Data integrity requires incorporation of the instrument into established workflows, with a robust audit trail, appropriate data export capabilities, and software that protects against data loss. More advanced instrument platforms are making this easier.”

Can you elaborate on how advanced systems and software are simplifying compliance?

“Sure. One important regulation for compliance is 21 CFR Part 11, which is a U.S. FDA regulation for electronic records. The iQue^® high throughput flow cytometer, a core instrument in our immuno-oncology toolbox, just released the 21 CFR Part 11 Software Module  to facilitate full GMP validation. This really simplifies a process that would otherwise rely on stand-alone software packages or third-party IT services.”

To wrap up, can you spare a few thoughts on the future of outsourcing biologics testing?

“CROs continue to be key drivers in drug development pipelines across the industry by providing expertise or simply additional capacity. The exciting push into cell and gene therapy fields happening across our industry is also influencing our offerings. For example, this year we launched an AAV testing portfolio with a range of GMP-compliant assays for AAV pipelines. We will continue to support our customers in their ambitions to develop these complex modalities.”

Learn more about the iQue^® platform and the 21 CFR Part 11 Software Module.