Monoclonal Antibodies Development and Support

Antibody characterization and lead verification involve assessing and selecting antibody candidates to validate their biochemical and biophysical properties. You can use robust characterization methods to help ensure that safe and effective lead antibodies are selected for subsequent development steps.

The following resources will help you learn about various technologies for studying antibody internalization and trafficking, characterizing antibody oxidation states, and more. To free up your team, you can also lean into our expertise by outsourcing your drug discovery activities.

Upstream process development is the first step of bioproduction and includes cell line development, cultivation, expansion and harvesting. In this early stage, choosing the right cell line, media and culture conditions is critical to help ensure product quality, high titers, future scale up opportunities and manufacturability.  

The following resources will help build your personalized mAb production workflow and include our highly flexible, standardized, single-use technologies, plus customized bioproduction solutions. If speed is what’s most important to you, consider our Quick to Clinic™️ program that can deliver large molecule drug substances for first-in-human studies in as little as 13 months from the start of transfection.

Downstream process development involves recovering, concentrating and purifying upstream bioproducts, then performing impurity and contamination testing to achieve a high-quality result. Rely on our world class expertise and comprehensive suite of solutions to help you increase reproducibility and efficiency in your downstream bioprocess.

The following resources will introduce our downstream bioprocessing capabilities, explain how you can accelerate antibody drug development with the right purification products, and give you a closer look at chromatography solutions for antibody therapeutics.

Preclinical studies involve conducting comprehensive experiments to evaluate the safety and efficacy of a therapeutic antibody and preparing for important regulatory filings. Successfully take your mAb programs to IND with the help of our analytical technologies, bioanalytical lab services, and regulatory consultation offerings.

The following resources will explain how we can support regulatory compliance in bioproduction, guide you as you try to get to IND/IMPD faster, and help you prepare regulatory strategies more confidently.

Carefully design and plan trials early on to build a platform for later-stage successes. Our team is here to help you navigate early phase clinical trials and offer expert-level support and services. From study design to site selection and risk mitigation, you’ll find what you need to effectively initiate studies.

The following resources will explain how we can help you during early phase clinical trial development, show you how to expedite the clinical process, and provide insights into the benefits and challenges of decentralized clinical trials.

As you strive to build a consistent, scalable and flexible clinical manufacturing workflow, look to us for vendor oversight and management services. Enhance your clinical manufacturing process with the right digital tools, plus supply assurance and regulatory support for secure trial execution. Whether you’re manufacturing in house or working with a CDMO, find what you need to keep your project moving.  

The following resources will introduce global supply solutions for clinical trials, help you build a reliable and harmonized supply chain for single-use consumables, and explain how Fisher BioServices can provide end-to-end chain of custody solutions for essential biological materials.

Clinical, medical and scientific oversight through protocol management and clinical trial review are critical for patient safety. As you outline your objectives and methods, be sure to assess risks and make informed decisions throughout the process to support the evaluation and potential approval of antibody therapies.

The following resources will explain how you can outsource clinical trial management for on-time delivery, share ways to help ensure participant safety in first-in-human trials, and help you prepare for new USP requirements for plastic packaging and manufacturing materials.  

Streamlining study data management, analysis and reporting can accelerate your clinical timeline. This involves maintaining compliance, interpreting data and publishing insights. As you complete each of these steps to align with regulatory requirements and industry best practices, you’re supporting the future safety and success of your project.

The following resources will provide innovative data solutions for delivering better outcomes, help you understand our bioanalytical service capabilities, and give you access to real-time lab data and results.

An early assessment of your method’s performance characteristics is critical for validation. These analytical considerations demonstrate the safety of your drug product and that it’s meeting the quality expectations outlined by regulatory bodies. Our team is here to help you mitigate risk with robust method validation and support so you can find a path forward and hit important milestones.

The following resources will help you embrace and manage late-stage development risks from scale-up through PPQ, provide an overview of flexible end-to-end biomanufacturing solutions, including our complete validation package, and explain what it means to navigate the complexities of PPQ.

In the presence of rigorous, evolving and heterogeneous payer evaluation criteria, challenging price negotiations, and a dynamic competitive environment, it’s important that you prepare your market access strategy early in the product life cycle and evaluate it often to help optimize market access. By understanding your objective and identifying key stakeholders, you can maximize your potential in target markets.

The following resources will connect you with consulting experts for actionable strategies, introduce you to informative access programs and studies, and help you understand how value is perceived to further your discussions during the development process.

Getting your medicine in the hands of healthcare providers and patients is the critical final step in any drug development journey. To help ensure the success of your project for years to come, continuous improvement and adaptability are key. As you monitor your commercial production process and meet market demands, leverage our CDMO services or production scale bioprocessing solutions to efficiently scale up for commercial manufacturing.

The following resources will provide an overview of our full range of CDMO services for drug commercialization, help you scale up for production with the right bioprocessing solutions, and describe the product lifecycle for increased safety.