| As part of Pfanstiehl’s continual commitment to producing the industry’s highest purity, lowest endotoxin and lowest metals (HPLE-LM) for bioprocessing components, two new D-Galactose products have been launched.
Pfanstiehl’s new D-Galactose (Plant Derived) High Purity / Low Endotoxin – Low Metal (G-126-3) product and D-Galactose (Plant Derived) High Purity / Low Endotoxin (G-126-2) product are now available for commercial sale.
Pfanstiehl has implemented specifications for the new G-126-3 and G-126-2 products to recognize a tighter control strategy for Plant Derived D-Galactose, which provides product consistency and better support for biopharmaceutical upstream processing requirements.
The specification for G-126-3 will exceed regulatory requirements. The setting of these specifications have been driven by the understanding of our industry’s requirements through extensive customer collaboration and reflects Pfanstiehl’s leadership in setting the industry standards with our HPLE-LM Excipient products and solutions.
While these products accommodate the increased customer driven requirements for elemental impurity control and ICH Q3D compliance, they are also compliant with ICH Q7 requirements.
“Use of Galactose in upstream cell culture has been documented and demonstrated to reduce accumulation of lactic acid and ammonia, both of which can interfere in the bioprocessing efficiency of the recombinant cells in culture producing therapeutic proteins. Concerns around impurities being introduced through addition of Galactose into cell culture that would have an impact on the product yield, protein integrity and glycosylation can be effectively addressed by using Galactose that is GMP produced, high purity/low endotoxin and contains lower levels of metals that are controlled and quantitatively characterized. Galactose is viewed as a cell metabolism modulator to improve performance of the cells and is more recognized as a critical component of cell culture media and feeds for production of protein therapeutics.” says Jagdish Kuchibhatla, Vice President of Sales and Marketing.
Pfanstiehl has samples from cGMP manufactured batches of D-Galactose available for customer qualification activities, along with a Product Profile and extensive product characterization data.
Pfanstiehl is the market leader of high purity / low endotoxin / low metal carbohydrates for biologics, biosimilars, vaccines, cell culture media and injectable (liquid and lyophilized) formulations and supplies its products to nearly all of the leading global biopharmaceutical companies. Pfanstiehl has manufactured parenteral grade excipients for more than 50 years, and Pfanstiehl’s excipients are critical formulation components in the majority of the top ten global blockbuster biopharmaceutical drugs which have been administered to thousands of patients around the world. Pfanstiehl’s HPLE-LM Excipient products are known as “best in class” due to their high purity, performance, consistency and quality attributes. |
