AGC Biologics: Leading the Way in Biopharmaceutical Services for Advanced Therapies
Learn how AGC Biologics provides top-tier biopharmaceutical services, specializing in the development and manufacturing of biologics and gene therapies.
Introduction
In the rapidly evolving landscape of the pharmaceutical industry, the demand for advanced therapies and biologics has surged. AGC Biologics stands at the forefront of this transformation, offering comprehensive biopharmaceutical services that cater to the development and manufacturing needs of innovative therapies. As a global Contract Development and Manufacturing Organization (CDMO), AGC Biologics is dedicated to improving patients’ lives by bringing cutting-edge biopharmaceuticals to market.
Our Mission and Purpose
AGC Biologics operates with a clear mission: to collaborate closely with clients to enhance patient outcomes through the delivery of life-changing therapies. Their purpose is to instill hope by enabling the creation and distribution of biologics and gene therapies worldwide, fostering a healthier and happier future for patients across the globe.
Comprehensive Biopharmaceutical Services
Development and Manufacturing Expertise
AGC Biologics offers a robust suite of services that encompass the entire spectrum of biopharmaceutical development and manufacturing. Their capabilities include:
- Mammalian Cell Development: Expertise in developing mammalian cell lines and processes from pre-clinical stages through to commercial production.
- Microbial Expression Systems: Proficient in expressing a variety of proteins, including antibody fragments, enzymes, and growth factors, using advanced microbial systems.
- Cell Therapy Services: Leveraging 30 years of scientific expertise to support cell therapy development with state-of-the-art technology and systems.
- Viral Vector Production: Innovating proprietary systems for AAV, LVV, and RVV vectors to meet diverse product platform needs.
- Plasmid DNA and mRNA Supply: Providing GMP and non-GMP plasmid DNA and messenger RNA essential for vaccines, RNA drugs, and gene therapies.
Advanced Therapies Focus
AGC Biologics specializes in advanced therapies, including gene therapies and cell-based treatments. Their commitment to innovation is evident in their proprietary platforms and real-time data monitoring tools, which enhance downstream process development and ensure the reliability and repeatability of microbial processes.
Innovation and Technology
Process Analytical Technology (PAT)
Emphasizing the importance of real-time data, AGC Biologics integrates Process Analytical Technology (PAT) into their manufacturing processes. This approach allows for continuous monitoring and optimization, ensuring that therapeutic products meet the highest standards of quality and efficacy.
Real-Time Data Monitoring
By utilizing real-time data monitoring, AGC Biologics can promptly address any issues that arise during the manufacturing process. This capability not only enhances product quality but also accelerates the development timeline, enabling faster time-to-market for critical therapies.
Global Presence and Regulatory Compliance
With a global network spanning North America, Europe, and Asia-Pacific, AGC Biologics ensures that their services comply with major regulatory agencies, including the FDA, EMA, PMDA, and others. Their strategic locations in key markets like Japan, Germany, and the USA facilitate seamless technology transfer and process development, supporting clients’ needs at every stage of their product’s lifecycle.
Commitment to Quality and Patient Care
Quality is at the core of AGC Biologics’ operations. Their stringent quality systems and inspection management processes guarantee compliance with cGMP standards, ensuring the safety, purity, and potency of every therapeutic product they develop. Furthermore, their dedication to environmental stewardship and responsible operations underscores their commitment to creating a sustainable and positive impact on global health.
Conclusion
AGC Biologics exemplifies leadership in the biopharmaceutical services sector, offering unparalleled expertise in the development and manufacturing of biologics and advanced therapies. Their comprehensive services, combined with a steadfast commitment to quality and innovation, position them as a trusted partner for pharmaceutical companies seeking to bring transformative therapies to market.
Discover how AGC Biologics can accelerate your biopharmaceutical projects today!
