Rentschler Biopharma presents new way to purify mAbs at PEGS Europe in Lisbon

Laupheim, Germany: – Full-service biopharmaceutical Contract Development and Manufacturing Organization (CDMO) Rentschler Biopharma SE has used the recent PEGS Europe Summit in Lisbon, Portugal, to outline a novel approach to monoclonal antibody purification.

The Rentschler Biopharma solution, presented by scientist Anja Trapp, uses caprylic acid-induced precipitation as a beneficial tool for mAb purification design.

Logarithmic improvement

Caprylic acid is well known to the pharmaceutical industry, having been used for decades to isolate immunglobulins from plasma. The hydrophobic molecules can interact with proteins inducing a precipitation. This mechanism can help to remove typical process- and product related impurities.

“The low pH virus inactivation step is especially useful in enabling a simple integration of capryl acid-induced precipitation,” said Anja Trapp.

“Using this approach, an additional host cell protein clearance of up to two logarithmic units is possible,” she added.

Alternative to column chromatography

Mrs. Trapp told the conference that a recent case study had shown that caprylic acid-induced precipitation could be implemented as “an excellent alternative” to column chromatography.

It was possible to completely remove host cell proteins, using the precipitation step. A third chromatographic column was no longer necessary to fulfill the final specifications.

Rentschler Biopharma is developing caprylic acid precipitation as a beneficial tool for the design of antibody purification processes, delivering benefits that include lower costs and the opportunity to utilize existing tanks and process flows.

About Rentschler Biopharma SE

Rentschler Biopharma, located in Laupheim, Germany, is a leading Contract Development and Manufacturing Organization (CDMO) for bioprocess development and manufacturing of biopharmaceuticals as well as for related consulting activities in terms of project management and regulatory support.

The Company’s clients include innovative biotech companies and major pharmaceutical companies around the world. Many years of experience and excellence in finding solutions as well as certified quality management and advanced technologies ensure Rentschler’s high quality standards.

Rentschler Biopharma is a family-owned company employing approximately 770 people.