As part of Pfanstiehl’s continual commitment to producing high-purity, low-endotoxin and low-metal (HPLE-LM) offerings for bioprocessing components, two new D-Galactose products were launched.
Pfanstiehl’s D-Galactose (plant-derived) HPLE-LM G-126-3 and D-Galactose (plant-derived) high-purity / low-endotoxin G-126-2 products are available for commercial sale.
Pfanstiehl implemented specifications for the new G-126-3 and G-126-2 products to recognise 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 was driven by the understanding of the industry’s requirements through extensive customer collaboration, and reflects Pfanstiehl’s leadership in setting the industry standards with its 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.
Pfanstiehl’s vice-president of sales and marketing Jagdish Kuchibhatla said: “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 good manufacturing practice (GMP) produced, high purity/low endotoxin and contains lower levels of metals that are controlled and quantitatively characterised.
“Galactose is viewed as a cell metabolism modulator to improve the performance of the cells and is more recognised as a critical component of cell culture media and feeds for production of protein therapeutics.”
Pfanstiehl has samples from current good manufacturing practice (cGMP) produced batches of D-Galactose available for customer qualification activities, along with a product profile and extensive product characterisation data.
Pfanstiehl is the market leader of HPLE-LM carbohydrates for biologics, biosimilars, vaccines, cell culture media and injectable (liquid and lyophilised) 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 its high purity, performance, consistency and quality attributes.