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ADA Assay Considerations: Rely on Sword Bio’s Unparalleled Expertise

ADA Assay Considerations

The Positive Control (PC) reagent is pivotal when embarking on a new anti-drug antibody (ADA) assay. Regulatory agencies typically favor polyclonal PCs because they represent the in vivo immunological response. While they have accepted monoclonal PCs, they often inquire about the rationale behind this choice. For straightforward biotherapeutics, a simple explanation suffices. However, as the complexity…

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Establishing Triple-spot MSD Assay for Manufactured Vector lot Release

Background Our client, a Biotech company developing a unique vector containing three critical proteins all of which are transmembranes, needed support with the development and validation of a 3-spot Meso Scale Discovery (MSD) electrochemiluminescence (ECL) multiplex assay, which would be used for the Manufacturing Lot Release of their vector. The requested service was to extract…

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Sword Bio Appoints Seth Reid as Vice President, Business Development

Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs for pre-clinical and clinical trials, announces the appointment of Seth Reid as VP, Business Development.  Seth joins Sword with a proven track record leading and supporting business development programs in the contract research space. Most notably, Sr. Director/Head,…

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ADA Assays Screening Viral Vectors For Gene Therapy

ADA Assays Screening Viral Vectors for Gene Therapy

By integrating modified or new genes into the cells of the human body, gene therapy has the potential to treat a wide variety of acquired and inherited diseases. Genetic therapeutics must deliver the intended genetic material to a large quantity of specific cells within the correct tissue. Properly targeting cells requires that the genetic material…

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Immuno-Oncology BioA: Pre-Existing ADAs Affecting PK

Immuno-Oncology BioA_ ADAs Affecting PK Challenges and Strategies

When administering human monoclonal antibodies, reconstituted human proteins, and antibody drug conjugates (ADCs), anti-drug antibodies (ADAs) can form and affect the Biotherapeutic’s exposure, bioavailability, and pharmacodynamic effects. The qualities of these ADAs – such as their specificity, magnitude, timing, maturity, and affinity – can impact pharmacokinetics (PK) and pharmacodynamics (PD). Challenges Presented by ADAs in…

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Sword Bio Appoints Kara Harrison as Vice President, Quality Assurance  

Welcome to the team - Kara Harrison

Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs for research, pre-clinical and clinical trials, announces the appointment of Kara Harrison as VP of Quality Assurance.   Kara joins Sword with a proven record of leading and scaling quality management programs and initiatives. Most recently, she was VP,…

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Understanding the Issues with ADA Assays

Streamline Immunogenicity Assay Development_ Expedite Research Workflows by Understanding the Issues with ADA Assays

The biotech industry is rapidly modifying and developing biotherapeutics into complex large molecules with specificity moieties and multiple functional domains to produce a specific biological method of action. (ADC, ACC, Bi-specific antibodies, Fusion proteins, recombinant-modified proteins, etc.) Therefore, developing LBA assays to detect the immunogenicity of these biotherapeutics is becoming very complex due to this…

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Sword Bio Appoints John Pirro as Director of Scientific Solutions

Welcome to the team John Pirro, Director, Scientific Solutions with quote I am so excited to be part of helping our partners with scientific analytical solutions and working with the Sword team to help our clients bring biological therapeutics into the marketplace

Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs for pre-clinical and clinical trials, announces the appointment of John Pirro as Director of Scientific Solutions. John joins Sword with a proven track record in the contract research space, providing scientific insight, guidance, and consultation. Most recently, he…

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Sword Bio Appoints David Osband as EVP, Sales & Marketing

welcome to the team

Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs for pre-clinical and clinical trials, announces the appointment of David Osband as EVP, Sales & Marketing. David joins Sword with a proven track record in the contract research space. Most notably, he was an owner of Cambridge Biomedical,…

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Sword Bio Appoints Matthew Langevin as Chief Operating Officer

Matt Langevin

Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs from development to clinical trials, announces the appointment of Matthew Langevin as Chief Operating Officer. Matt joins Sword with exceptional experience and a proven track record in the contract research space. Most notably, he was Co-Founder of BioAgilytix,…

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