EirGenix is a contract development and manufacturing organization that provides high-quality and cost-effective service.  We support our clients in the development, analytical testing, and cGMP manufacturing of biopharmaceuticals from pre-clinical to commercial manufacturing. EirGenix also specializes in the development of biologics, specializing in the development of biosimilars.

Our Services:
- Cell Line Development (mammalian/microbial systems)
- Process Development and Process Optimization
- Analytical Services and Quality Control
- cGMP Manufacturing (mammalian/microbial systems)
     - Taiwan FDA inspected/approved
     - Japan PMDA inspected/approved
     - U.S. FDA inspection pending (June 2022)
     - EMA inspection pending (2022-2023)
- Antibody-Drug Conjugate (ADC) Development and Manufacturing

Biotechnology

Manufacturing

Pharmaceutical

EirGenix, Inc.

Thomas Schulze

Ywan - Feng Li

Sunny Wang

The Business Development team at EirGenix, Inc. is responsible for identifying and pursuing new business opportunities to support the company's growth and expansion in the biopharmaceutical industry. This involves building and nurturing relationships with potential clients, negotiating contracts, and developing strategic partnerships. The team also works to understand market trends and client needs to position EirGenix's services effectively, ensuring the company remains a competitive and innovative leader in biopharmaceutical development and manufacturing.

Business Development

The Leadership Team at EirGenix, Inc. is responsible for overseeing strategic planning, operational excellence, and regulatory compliance across all facets of the company. They guide the organization to ensure high-quality, cost-effective service in biopharmaceutical development and manufacturing. This team spearheads executive decisions, international expansion, and the advancement of key projects, such as regulatory approvals and novel biologics development initiatives.

Leadership Team

The Project Management and Operations team at EirGenix, Inc. coordinates and oversees the comprehensive lifecycle of biopharmaceutical development projects, ensuring alignment with client objectives and regulatory guidelines. Their responsibilities include managing timelines, resource allocation, procurement, and cross-functional collaboration to facilitate the development, analytical testing, and cGMP manufacturing of biologics, including biosimilars and antibody-drug conjugates. This team ensures projects are delivered on time, within budget, and to the highest quality standards, supporting pre-clinical to commercial manufacturing stages.

Project Management and Operations

The Quality and Regulatory Affairs team at EirGenix, Inc. is responsible for ensuring compliance with global regulatory requirements and maintaining the highest standards of quality across all operational processes. This includes overseeing analytical testing, quality control, and adherence to cGMP manufacturing practices. The team works to ensure that all products meet stringent international quality and safety standards, facilitating successful regulatory inspections and approvals.

Quality and Regulatory Affairs

The Engineering and Process Team at EirGenix, Inc. is responsible for designing and optimizing biopharmaceutical production processes. This includes the development of scalable and efficient upstream and downstream bioprocesses, ensuring the facilities are designed to meet regulatory standards, and managing construction projects for new manufacturing capabilities. The team plays a crucial role in translating lab-scale operations into full-scale manufacturing, thereby supporting the company’s commitment to high-quality and cost-effective biopharmaceutical production.

EirGenix, Inc.

Org chart

Teams

Business Development

Leadership Team

Project Management and Operations

Quality and Regulatory Affairs

Engineering and Process Team

Offices

EirGenix, Inc.

Org chart

Teams

Business Development

Leadership Team

Project Management and Operations

Quality and Regulatory Affairs

Engineering and Process Team

Offices

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