Capabilities

Discover our commitment to deliver through each phase of the process.

Process Development

Number_1.svg PROCESS DEVELOPMENT

At AGC Biologics, we have developed more than 200 mammalian, bacteria and yeast-based processes, giving us the insight necessary to identify and optimize development parameters that are critical for achieving a high-quality, cost-effective manufacturing process for your product.

Developing an efficient, scalable, validated, and cost-effective manufacturing process is essential for success in today’s competitive biologics markets. Whether you need assistance developing a new process, are improving existing processes, or are preparing to manufacture your product, you will benefit from our in-depth expertise.

Number_2.svg CGMP MANUFACTURING

AGC Biologics has successfully manufactured more than 200 biological products for pre-clinical studies through commercial approvals. Our global  facilities across the United States, Europe, and Asia offer multiple cGMP manufacturing lines and a variety of scales for mammalian cell culture and microbial fermentation.

The innovative design of our state-of-the art facilities allows for capacity and technological flexibility, while ensuring compliance with the strict biopharmaceutical regulations required for cGMP operations. Our dedicated and experienced technical teams are committed to helping each client meet its clinical and commercial goals.

 CAPACITY
(Vessel Volume)
 MICROBIAL
 MAMMALIAN
5L and 10L (NON-cGMP)
H
 
2L - 15L (NON-cGMP)
C
 
100L MICROBIAL PILOT PLANT (NON-cGMP)
C
 
150L cGMP STAINLESS
H
 
300L cGMP STAINLESS
Y
 
400L cGMP STAINLESS
Y
 
1500L cGMP STAINLESS
CH
 
4500L cGMP STAINLESS
CH
 
2L - 15L (NON-cGMP)
 
C
50L AND 100L CELL CULTURE PILOT PLANT
(NON-cGMP)
 
C
100L cGMP STAINLESS
 
C
100L AND 500L cGMP SINGLE USE
 
C S B
500L cGMP STAINLESS
 
B
750L cGMP STAINLESS
 
S
2000L cGMP SINGLE USE
 
C S B
3000L cGMP STAINLESS
 
S B
S Seattle, Washington, US
C Copenhagen, Denmark
B Berkeley, California, US
HHeidelberg, Germany
YYokohama, Japan
CHChiba, Japan
Quality and Regulatory

Number_3.svg QUALITY and REGULATORY

Quality matters — to patients, regulatory authorities and our clients. AGC Biologics’ quality organization provides a comprehensive suite of Quality Assurance (QA) and Quality Control (QC) services. Highly trained Quality Units maintain strict quality systems at each of our manufacturing facilities to support our cGMP manufacturing efforts and to ensure compliance with all regulatory requirements.

Our US site is commercially approved by the U.S. Food and Drug Administration (FDA) for commercial cGMP production of a protein therapeutic product. The site also recently completed a successful pre-approval inspection (PAI) for a second product.  In addition, our Copenhagen facility completed successful pre-approval inspections by FDA and the European Medical Authorities in 2015 and is awaiting approval of this product.

Process Validation

Process validation is a critical and significant activity for customers preparing for commercial approval. AGC Biologics’ well-defined approach and supporting Quality Systems provide a straightforward path through process validation.

Read Our Case Study

 Key Process Validation components:
  • Identification of Critical Quality Attributes
  • Risk assessments
  • Identification of Critical Process Parameters
  • Process Control Strategy
  • Bench-scale model qualification
  • Scale characterization/ DOE studies
  • At-scale conformance campaign
  • Continuous Process Validation Plan