8 critical attributes your raw material testing partner must have

Kim Rhoades, Senior Director, Pharmaceutical Raw Materials, Kimberley.Rhoades@bpt.eurofinsus.com; Derek Stanley, Vice President, Business Development, Derek.Stanley@BPT.EurofinsUS.com

Raw material testing is essential as drug developers traverse the various stages of clinical development from qualification of vendors to ongoing support for commercial products. Establishing the identity, purity, and quality of starting materials helps avoid regulatory obstacles, costly production problems, delays, and most importantly ensures efficacy and safety for patient use. Here are 8 critical attributes to look for in your ideal raw material testing partner.

1. Vast Compendial Experience & Collaboration – Despite a prescriptive appearance, the global compendia are a challenging landscape to navigate. An ideal partner has decades of experience with USP, EP, and JP monographs and direct connections to collaborate and troubleshoot with those organisations.

2. Extensive Capacity & Assurance of Supply – Due to the myriad of techniques required to support a comprehensive raw material testing programme, you need a well-resourced partner who has instrumentation redundancy and well-trained technically diversified personnel to support the various tests. To minimize risk, your partner should have multiple sites on the same continent, providing these services.

3. World-class Turnaround Times & RUSH Capability – Even the most well-run manufacturing sites have an occasional oversight in their raw material and excipient supply, which causes raw material release to fall on the critical path. You need a partner with fast standard turnaround times, an ability to receive samples seven days a week, an operation that spans multiple shifts, and most importantly is able accommodate rush turnaround time requests to avoid impacts to your manufacturing schedule.

4. Digitalisation – The industry drive towards digitalisation ensures faster turnaround times, increased regulatory compliance, and few resources in your organisation processing outgoing samples and incoming data. An ideal partner would provide online ordering, including time-saving reorder functionality, online test/sample status visibility, delivery of electronic laboratory notebook raw data, and an option for LIMS-to-LIMS connectivity.

5. Comprehensive Modality Support – Your raw material testing partner should be able to support your ever-growing, mixed modality, diversified pipeline. They need to be experts in testing starting materials utilised to manufacture small molecules, traditional biologics, antibody drug conjugates, peptides/oligonucleotides, as well as cell and gene therapy products. Many of these newer modalities require technical and regulatory expertise to guide and execute strategies for non-compendial materials.

6. Global Footprint Mirroring Your Supply Chain – As your clinical trials and commercial launches expand globally, the raw material testing partner you’ve worked hard to establish a relationship and trust with should be there to continue the journey with you. Executing a global strategy presents enough challenges; finding a new raw material testing provider shouldn’t be one of them.

7. Industry Leading Regulatory Compliance & IT Security – Two of the greatest risks to your supply chain are gaps in regulatory compliance and IT security of your service providers. You need a partner that has a comprehensive understanding of both landscapes, has the resources to continuously invest and derisk their operation, and one that is routinely audited by global regulators and the broader industry.

8. Value – Any lab can provide a CoA. A true partner is going to provide you and your organisation with the greatest value for your spend as you work together to ensure the safety, efficacy, and availability of your life-saving product for patients. For more information, visit: www.eurofins.com/biopharma-product-testing-services/quality-control/raw-materials-and-excipient-testing/