AGC Biologics: Company Research Report

Company Overview

• Name: AGC Biologics

• Mission: To work side by side with customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

• Founded By: No information is available.

• Key People:

• Alberto Santagostino, Chief Executive Officer

• Patricio Massera, Previous CEO

• Tadashi Murano, President of AGC Life Science Company

• Headquarters: No information is available on the specific headquarters location.

• Number of Employees: The new Yokohama facility will employ 400 people.

• Revenue: No information is available.

• Known For: AGC Biologics is known for its global contract development and manufacturing organization (CDMO) services, providing development and manufacturing solutions for protein-based biologics and advanced therapies.

Products

Offerings

• Mammalian

• Expertise in mammalian expression and monoclonal antibody manufacturing.

• Microbial

• Fully licensed freedom-to-operate (FTO) capabilities for strain development.

• Plasmid DNA (pDNA)

• Production capabilities covering all grades and quantities for various applications.

• Viral Vectors

• Development and manufacture of lentivirus, retrovirus, and adeno-associated viral vectors.

• Cell Therapy

• Services ranging from plasmid DNA production to engineering cells via viral vectors.

• Messenger RNA (mRNA)

• Provides both R&D and GMP grade mRNA to support program needs.

Key Features

• Access to a global cGMP manufacturing network ensuring compliance and flexibility.

• Proprietary platforms such as AGCellerate™, ProntoLVV™, BravoAAV™, and Proveo™ ADC for specialized manufacturing services.

Recent Developments

New Products and Features

• Pre-qualified End-to-End Lentiviral Platform: Streamlines processes to achieve GMP in reduced time.

• Templated Adeno-Associated Vector Platform: Comprehensive solution from pre-clinical to commercial production stages.

New Developments

• New Manufacturing Expansion in Yokohama: A 20,000 m² four-story facility planned to be operational by 2026, focusing on mammalian cell culture, mRNA, and cell therapy services.

• Inspection and Licensing Successes: The Copenhagen facility received licensing from the Danish Medicines Agency.

Partnerships

• Strategic Partnership with BioConnection:

• Provides seamless end-to-end drug product development.

• Addresses needs in the wake of the proposed U.S. BIOSECURE Act.

• Offers a "gene to vial" service chain.

• Collaboration with Orchard Therapeutics:

• AGC Biologics’ Milan site will manufacture Orchard Therapeutics’ Lenmeldy™ gene therapy, approved by the U.S. FDA for MLD treatment.

• Partnership with CompleCure:

• Developing advanced anti-cancer therapeutics using pioneering AMDC technology at the Chiba site.

Leadership Changes

• Alberto Santagostino appointed as the new CEO, bringing comprehensive experience from his tenure at Lonza and McKinsey & Co.

Overall, AGC Biologics continues to expand and innovate within the biopharmaceutical sector, maintaining its commitment to providing high-quality development and manufacturing services globally.