Whitepapers

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains. Having a team of individuals with specialized expertise in different areas of clinical supply—including protocol review and early operational planning, to managing the development and execution of a sound clinical supply strategy—can prove invaluable to the overall suitability and performance of the supply chain, and in turn, the successful execution of the study itself.

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client. Additionally, once the CRO has been awarded the project and now must create an executable plan for managing the study’s complex clinical supply needs, there are one or more key decision influencers who are critical to engage early on during the planning and project set-up stage and several proactive steps to take to build a solid clinical supply plan.

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Selecting the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.

Standardized manufacturing through a Recipe-Driven Execution environment and digital twins minimizes effort duplication while simplifying operations, harmonizing production processes, and accelerating speed to patient.

QbCon® 1 offers the optimal entry into continuous production. Our truly continuous wet granulator and dryer for research and development guarantees improved product quality while increasing flexibility and operator safety. It also reduces costs by using fewer resources and shortens development cycles by process analytics. Unlike competing systems, QbCon® 1 enables a permanent, truly continuous process without the formation of sub-batches and blocked filters.

This asset outlines the comprehensive support and guidance offered by the FAS team for optimizing monoclonal antibody (mAb) manufacturing processes using the Efficient-Pro medium and feeds. Readers will learn about the tailored assistance provided at every stage, including troubleshooting, recommendations

Biopharmaceutical companies are increasingly partnering with CDMOs equipped with technologies and expertise to support analytical testing during process development. The level of complexity required to develop and manufacture cell and gene therapies has increased, including the use of various raw materials, custom reagents, and tailored approaches for managing complex diseases.

The Gibco Efficient-Pro Medium and Feeds Evaluation Guide provides insights into enhancing monoclonal antibody manufacturing workflows. Offering improved titers, viability, and protein quality in CHO cell lines, it introduces a comprehensive evaluation process for maximizing productivity. Explore this asset for detailed step-by-step guidance and troubleshooting tips

Discover how the Gibco™ Efficient-Pro™ system boosts productivity, enhances cell viability, and ensures superior product quality with minimal impurities. Packed with detailed fed-batch study results, this guide offers actionable insights and practical tips to optimize your bioproduction processes, ensuring you achieve higher yields and consistent, high-quality outcomes. Dive into this indispensable asset to elevate your manufacturing workflow to the next level.

In this asset, you will discover how the Gibco Efficient-Pro system can revolutionize your mAb manufacturing workflow. It provides insights into optimizing CHO cell productivity, enhancing product titers and protein quality, streamlining process efficiency, and leveraging a reliable supply network.

Learn about the importance of considering human factors testing beyond the initial validation phase. Through two case studies, it illustrates how seemingly minor product changes can trigger regulatory scrutiny. The message is clear: proactive testing and expert guidance are essential to navigate regulatory requirements effectively.

Raw material testing is critical for drug development, ensuring safety and efficacy. Look for a partner with extensive compendial experience, ample capacity, fast turnaround times, digital capabilities, modality expertise, global presence, regulatory compliance, and a focus on value.

EBPT Toronto expands Eurofins BioPharma Product Testing's North American presence, offering comprehensive product testing services in Toronto. With a focus on cGMP compliance, the facility provides chemistry, microbiology, and regulatory consulting services, including testing for controlled substances. It ensures consistent quality across its network, prioritizing customer satisfaction and regulatory compliance throughout the drug development process.

The Toxicology Team in Lancaster now offers expanded services including biological evaluations to help clients with biocompatibility strategies and regulatory compliance. We provide tailored consulting for specific needs like mitigating biological risks due to product changes or failed tests. Each project is evaluated individually, ensuring customized solutions and enhanced client value.

Eurofins BioPharma Product Testing in Lancaster, PA, is a leader in ensuring the quality and safety of cell banks used in biomanufacturing. Certified by regulatory agencies like the FDA and TGA, EBPT's Cell Banking Department operates under stringent quality standards. We employ controlled processes, including employee training and contamination control, to maintain quality. With global certification, EBPT's laboratories are equipped to meet manufacturing needs worldwide.