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Expert bioanalytical services

What do all therapies under development have in common?

Whether in the discovery, pre-clinical or clinical stage, they all need robust and reliable biomarker monitoring tools to track and characterize their biological effect.

Your Challenge

Monitoring biomarkers is a powerful tool to objectively measure the efficacy of a drug, predict its safety, document its mechanism of action and potential impact on the immune system. With decades of expertise in biomarker analysis, PK/PD, and immunogenicity testing, Active Biomarkers transforms your precious and unique clinical samples into reliable data to drive your decisions in the development of your innovative therapies.

Our Strengths
Our Approach

Chameleon

Very early in the discussions, our experts are involved in order to make sure that we get a good understanding of your needs and offer the most appropriate analytical solutions for your project.

ContACT for support

Chess game

With decades of experience in the development, optimization, and validation of custom cell-based and immune-assays, we can either develop methods from scratch, transfer them from a reference laboratory, optimize them, and, depending on their intended use, qualify or validate them for subsequent routine applications.

Sample management

We provide full technical support from sample preparation and cryopreservation, relying on standardized procedures, to storage. We work with trusted partners worldwide. We can provide technical and quality support for the evaluation and, if needed, training of laboratories involved in sample preparation.
Because clinical samples are unique, our freezers and Nitrogen tanks are 24/7 monitored.

Data safety

Testing results are absolutely central for your projects. We take extra care to fully track, secure and warranty the total confidentiality and security of your data during the course and after completion of your project.

Quality level

Quality is not an act; it’s a habit! (Aristotle)

ACTIVE BIOMARKERS is certified according to ISO 9001:2015 « Quality Management systems » standards, fully accredited to GCLP (Good Clinical Laboratory Practices) and compliant to GLP (Good Laboratory Practices). We follow the Good Clinical Practices (CPMP/ICH/135/95) and the Good Laboratory Practices (as revised by the OECD in 1997) as referential guidances.

ACTIVE BIOMARKERS has dedicated Quality Assurance and Quality Control teams that are committed to a quality-based and systematic approach for the development of products and services to meet our customers’ expectations and requirements. QA unit is headed by the Quality Director and is independent of the Operations and Technical Services.

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Synapse

Active Biomarkers has developed strong expertise in two main therapeutic areas: Immune-related disorders (Infectious, Inflammatory, Auto-Immune diseases, and Immuno-Oncology) and Neurological disorders.

We support pre-clinical and clinical studies, evaluating the safety, efficacy, and mode of action (MOA) of (Immuno)therapies through PK/PD, immunogenicity, biomarker analysis. Active Biomarkers has been supporting the development of innovative immunotherapies, including but not limited to antibody-based therapies (e.g., mAbs, Bispecific T cell Engagers, etc.), personalized neoantigen vaccines, CAR-T cells, or oncolytic virotherapies.

Antibody

In order to provide you with bioanalytical solutions fitting your needs (soluble or cell-based biomarkers, multiparametric, ultrasensitivity) and constraints (sample volume, turn-around-time), Active Biomarkers relies on a wide range of technological platforms.

Our latest newsletters

  • May 11, 2023

Navigating Company Expansion with Integrity & Engagement

Clinical research carries significant risks and numerous obstacles that must be overcome to achieve success. Identifying the ideal Contract Research Organization (CRO) to partner with is a critical component of this journey. Exceptional CRO partners must exhibit scientific expertise, offer technical capabilities, handle complex sample management, and consistently deliver high-quality results. Yet, one crucial aspect remains often overlooked: the human relationships.

For those who value open and trustworthy collaboration, flexibility, and agility in their bioanalytical partner, a human-sized organization that can maintain these qualities while expanding its international presence is a rare find. This blog explores the benefits arising from international expansion and the challenges faced in maintaining core values and strengths in a fast-growing company.

Benefits Arising from International Expansion

Streamlined Sample Management: The company's strategic locations in Europe and the US enable the streamlining of the bioanalysis process, accelerating clinical trial timelines, and efficiently handling and processing samples (whole blood, plasma, PBMCs) from diverse sources. Clients benefit from the organization's commitment to guiding them through the sampling process, ensuring optimal results. Adherence to strict protocols, highly trained personnel, state-of-the-art facilities, cutting-edge equipment, and the right standard operating procedures (SOPs) make these locations ideal for sample processing.

Broad Expertise, Comprehensive Technology Offerings, and Tailored Assay Solutions: Access to fit-for-purpose technologies is essential for clients in an industry where technology and expertise are crucial. The investments in cutting-edge LBA platforms, Flow Cytometry, ELISpot, LC-MS/MS, and molecular biology technologies enables to offer comprehensive assay solutions, such as ADA, pharmacokinetics, and biomarker packages, covering multiple services. Integrated scientific expertise across various therapeutic areas and unique specializations in locations like Kansas City, Phialdelphia, and Lyon allows clients to receive solutions specifically tailored to their project needs.

Capacity, Speed, and Support for Late-Stage Clinical Trials: Late-stage clinical trials require efficient results delivery without compromising quality. Thanks to increased capacity and employing efficient methodologies and processes across the Atlantic the team can ensure that high-volume projects can be managed efficiently, meeting clients' needs in a timely manner.

Consistent Systems Across Sites: Clients seeking uniform results across locations require a harmonization strategy that encompasses eQMS, QA systems, SOPs and Watson LIMS. This ensures that key assays and other procedures are consistent, regardless of the site, allowing clients to trust the quality and reliability of the results in international clinical trials.

Preserving Core Values While Expanding

As the company expands, maintaining core values such as transparent communication, flexibility, and nimbleness becomes a complex balancing act. Indeed, expansion risks hindering the agility that characterizes the US and European locations, demanding solutions to preserve its identity.

The Human-to-Human Interaction: The most important challenge during growth is maintaining the human aspect and excellent customer service. Having a principal investigator seamlessly and efficiently plug into your project, understanding your challenges, provide timely communication and committed to efficiently delivering the most appropriate solutions is essential to advance your project from early preclinical development to late-phase clinical stage. This in combination with a highly trained scientific staff with tailored problem-solving experience elevates the partnership, transforming it into a truly collaborative, supportive endeavor.

Maintaining Nimbleness and Flexibility: In the context of shorter lead times and tailored on-time/budget solutions, preserving nimbleness is crucial. Ensuring that projects move forward expeditiously becomes a daunting task, one that requires constant attention and recalibration. Success in this arena is achieved through seamless communication, efficient decision-making, as well as swift and well-organized execution.

Retain our most valuable asset, our people: All this relies on a human resources policy oriented towards work-life balance, long-term engagement, retaining talents, leveraging and developing employees’ skills. Limiting staff turn-over contributes to keeping intangible knowledge, based on personal stories, previous experience, and skills, but also ensuring our clients a long-term relationship with its preferred intermediary.

 

Key Takeaways

Adapting and growing while staying true to core values is crucial in the evolving clinical research landscape. If a combination of engagement, experience and skills in key therapeutic areas, technologies, methodologies, and workflows is important to your organization, consider our team as a partner of choice. As a pioneer in the field of bioanalysis our company has a proven track-record with world-leading pharma and biotech companies and has tailored its processes and team to manage complex clinical trial programs. In 2022, the company brought over 95,000 square feet of state-of-the-art laboratory space in the US alone, carefully designed to strengthen its position as a premier service provider. This expansion not only enhances the CRO's capabilities but also demonstrates its dedication to meeting the changing needs of the industry.

  • June 23, 2022

Is your Biomarker Strategy Up-to-Date?

Is your Biomarker Strategy Up-to-Date?

Research on neurological biomarkers is a very dynamic field. The recent FDA approval of a diagnostic test measuring the Amyloid-beta 1-42 / 1-40 ratio in CSF for Alzheimer's disease, or the breakthrough device status granted to a blood test measuring NfL levels in Multiple Sclerosis are a clear illustration of this trend.

At Active Biomarkers, we have implemented methods to detect neurological biomarkers in both CSF AND Blood matrices, using ultrasensitive immunoassays when required.

Learn more here

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