Agenus Case Study

Quality Alignment After Acquisition

Agenus Case Study

Quality Alignment After Acquisition

agenus (case study heading image)

Agenus Project Highlights

  • GMP Antibody Manufacturing Pilot Plant
  • Berkley, CA and Lexington, MA
  • 2018: Rapid, comprehensive audit of quality procedures at California and Massachusetts manufacturing sites
  • Aligned quality and validation processes at both sites, including a company-wide quality management program
Agenus Case Study - Quality Alighnment After Acquisition
agenus (case study heading image)

Agenus Project Highlights

  • GMP Antibody Manufacturing Pilot Plant
  • Berkley, CA and Lexington, MA
  • 2018: Rapid, comprehensive audit of quality procedures at California and Massachusetts manufacturing sites
  • Aligned quality and validation processes at both sites, including a company-wide quality management program

Growth through acquisition is an SOP for the biopharmaceutical industry. Once a deal is done, however, the hard work of operational integration and quality management is essential for realizing the expected benefits.

In early 2016, a company based in Lexington, Massachusetts acquired an established GMP antibody manufacturing pilot plant in Berkley, California. It was a strategic acquisition that added important capacity to make antibodies for the Lexington company’s growing immuno-oncology clinical programs.

The acquired plant’s experienced chemistry, manufacturing, and controls (CMC) team remained with the merged company to operate the facility and adapt their processes to support new programs.

“We recognized that there was a need to develop and align quality management systems (QMS) between the two manufacturing sites while maintaining industry standards and best practices.”

Former Senior Director
of Quality Assurance

“ICQ performed an audit of our facilities, quality systems, and operational readiness and outlined a simple yet thorough executable and effective strategy. They proceeded through the execution plan that exceeded expectations.”

Former Senior Director of Quality Assurance

“ICQ performed an audit of our facilities, quality systems, and operational readiness and outlined a simple yet thorough executable and effective strategy. They proceeded through the execution plan that exceeded expectations.”

Former Senior Director of Quality Assurance

The QA director had worked with ICQ President Michael Bogan in the past, so she reached out for help with the QMS project. ICQ launched the effort in 2018 with a three-person team to conduct a rapid, but comprehensive audit of their quality procedures and programs at the manufacturing sites in California and Massachusetts.

The results of the ICQ audit became the basis for an implementation plan that aligned the quality and validation processes at both sites, raising the bar in some cases to meet current best practices. Institutional knowledge among both teams was respected and synthesized into a new company-wide quality management program.

“Even though everyone has to play by the same rules, GMP facilities will generally have their own way of doing certain things, so it is essential to take a comprehensive approach, identify areas that diverge, and align systems within a unified quality management framework.”

Michael Bogan, President, ICQ