CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Best Practices for RIM Business Process Automation

December 15, 2022

Best Practices for RIM
Regulatory teams at life science companies are finding that
effective regulatory information management (RIM) has become critical to their operations.

Spotlight

Vaxon Biotech

Vaxon Biotech is a biotechnology company based out of Calle Laguna del Marquesado Nª 19, Nave 16 Edificio Adriana 1ª Planta, Polígono Industrial La Resina (Villaverde), Madrid, Community of Madrid, Spain.

OTHER WHITEPAPERS
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IoT To The Rescue For Biotech & Pharma Manufacturing

whitePaper | April 7, 2020

The Internet of Things (IoT) could not be timelier for biotech/pharma. With fierce cost pressures, the push for value-based outcomes, and the need for flexible manufacturing solutions, the IoT is the much-needed shot in the arm to bring about transformational change. Sensors, actuators, and devices (“things”) embedded in production equipment and networked through computer systems can generate an enormous amount of data. The data can be mined for insights and opportunities to drive production efficiency, automate monitoring and controlling functions, and enable flexible manufacturing systems.

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Asia Pacific – Clinical trial landscape

whitePaper | November 28, 2022

The Asia-Pacific area is home to around two thirds of the world’s population and has a wide range of cultural, political, economic, and other factors that affect vaccine development, use, and registration.

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Advanced Biopharmaceutical Manufacturing: An Evolution Underway

whitePaper | June 5, 2022

The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases.

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Benefit-Risk Considerations for Product Quality Assessments; Guidance for Industry; DRAFT GUIDANCE

whitePaper | May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

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Impurity profiling and analysis of TheraPure GMP nucleotides

whitePaper | March 22, 2023

Nucleoside triphosphates (NTPs) are key building blocks of many nucleic acid therapeutics and vaccines. These molecules are a vital component of revolutionary new medicines.

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Cell Lysate Sample Handling with Simoa Bead-Based Assays

whitePaper | November 12, 2019

This document describes a novel Quanterix lysate diluent for running lysate samples with Simoa assays diluent.

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Spotlight

Vaxon Biotech

Vaxon Biotech is a biotechnology company based out of Calle Laguna del Marquesado Nª 19, Nave 16 Edificio Adriana 1ª Planta, Polígono Industrial La Resina (Villaverde), Madrid, Community of Madrid, Spain.

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