How Fast-Track Pharmaceutical Analytical Services Support Project Investigation for Manufacturing Failures

The Challenges of Manufacturing Failures in Drug Development

Drug manufacturing is a complex process that involves multiple stages, each with its own set of challenges. From formulation and stability to equipment compatibility, numerous factors can affect product quality. The most common manufacturing failures include:

• Contamination: The presence of foreign particles can compromise drug safety.
• Formulation Stability Issues: Changes in the physical or chemical properties of the drug can impact its efficacy.

Such failures can have far-reaching consequences, including increased costs, delays in product release, and non-compliance with regulatory standards. The stakes are especially high when it comes to drugs for rare diseases, where patient access to life-saving treatments is critical.

Fast-Track Analytics: A Vital Tool for Quick Resolution

Fast-Track Pharmaceutical Analytical Services are designed to address urgent manufacturing issues that require rapid investigation. Unlike traditional analytical services that may take weeks to deliver results, Coriolis Pharma’s fast-track approach focuses on speed without compromising accuracy. This service is particularly beneficial when delays could prevent patients from receiving critical therapies.
These Fast-Track Pharmaceutical Analytical Services are not standalone but are offered under the broader umbrella of forensic analytical services. Forensic services encompass a range of techniques to identify the root cause of manufacturing issues, with Fast-Track Pharmaceutical Analytical Services being a specialized subset for urgent cases, particularly related to batch release.

How Coriolis Pharma’s Fast-Track Pharmaceutical Analytical Services Work

Coriolis Pharma’s approach to Fast-Track Pharmaceutical Analytical Services is centered around the need for speed and precision. The process typically starts when a client identifies an issue in their drug batch, such as visible particles detected during visual inspections. Here’s how Coriolis Pharma handles these urgent cases:

1. Sample Assessment and Particle Identification: Clients send samples to Coriolis, where their team of experts performs rapid particle identification using advanced technologies such as Raman microscopy, SEM-EDX, and FTIR. These techniques help determine the nature of the contaminant, whether it’s protein aggregation, glass, or metal particles.
2. Data-Driven Consultation: After identifying the contaminants, Coriolis provides a detailed report and offers consultation on how to resolve the issue. These recommendations include troubleshooting and optimization strategies to prevent future occurrences.
3. Expedited Turnaround Times: Depending on the urgency, Coriolis Pharma can deliver results in as little as two to four days, ensuring clients can make informed decisions quickly. This rapid response is crucial for batch release approvals, especially when lives are at stake.

Real-World Applications of Fast-Track Pharmaceutical Analytical Services

A prime example of how Coriolis’ Fast Track Services can make an impact is in manufacturing troubleshooting support. Coriolis was contacted by a top 20 pharmaceutical company where visible particles have been observed during the production of its vaccine and needed immediate assistance with its investigation. Within two days of receiving samples, Coriolis was able to provide concrete information about the identity and possible source of the observed particles. The findings also enabled the customer to optimize their processes and significantly reduce the occurrence of particles in future batches.
In another case, a client required immediate particle identification to release a GMP batch for human use. The client’s internal team detected visible particles but lacked the capacity to perform detailed analysis quickly. Coriolis delivered results within days, allowing the client to proceed with batch release, thereby ensuring that patients received their medications on time.

The Advantages of Coriolis Pharma’s Forensic Services

While many large pharmaceutical companies have internal forensic labs, they often face challenges with capacity and speed. This is where Coriolis Pharma’s Fast-Track Pharmaceutical Analytical Services stand out. By providing specialized expertise and quick turnaround times, Coriolis fills a critical gap, even for companies with significant in-house capabilities.
Some key differentiators include:

• Comprehensive Expertise: Coriolis Pharma’s team is equipped with a wide range of analytical tools, including mass spectrometry and advanced microscopy techniques, which allow them to tackle complex manufacturing challenges.
• Consultative Approach: Unlike many competitors, Coriolis goes beyond simply delivering data. Their experts interpret results and provide clients with strategies for optimizing their processes.
• Flexible Service Models: Coriolis offers a standard expedited model (results in 8 days) and an even faster convenience model (results in 4 days), allowing clients to choose the level of urgency that best suits their needs.

Avoiding Future Failures Through Proactive Analytics

One of the key lessons learned from Fast-Track Pharmaceutical Analytical Services is that prevention is better than cure. By leveraging forensic services early in the drug development process, companies can identify potential risks before they escalate into major issues. Coriolis Pharma’s predictive analytics and preventive testing capabilities are invaluable in this regard, helping clients safeguard their projects and reduce the risk of costly delays.
Moreover, by partnering with Coriolis Pharma, companies can access a dedicated team of experts who troubleshoot existing issues and help plan for the future. This proactive approach ensures that clients remain compliant with regulatory standards and maintain their competitive edge.

Partnering with Coriolis Pharma for Fast-Track Analytical Excellence

In today’s fast-paced pharmaceutical landscape, quickly identifying and resolving issues can make or break a project. Coriolis Pharma’s Fast-Track Pharmaceutical Analytical Services, offered under its comprehensive forensic services umbrella, provide clients with the speed, precision, and expertise needed to overcome manufacturing failures.
Whether it’s particle identification, root cause analysis, or preventive testing, Coriolis Pharma is committed to supporting its clients in delivering safe and effective therapies to patients without delay.

To learn more about how Coriolis Pharma can support your drug development program, contact us today.