As part of Pfanstiehl鈥檚 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鈥檚 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.聽The setting of these specifications was driven by the understanding of the industry鈥檚 requirements through extensive customer collaboration, and reflects Pfanstiehl鈥檚 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鈥檚 vice-president of sales and marketing Jagdish Kuchibhatla said: 鈥淯se 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.
鈥淐oncerns 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.
鈥淕alactose 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.鈥�
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鈥檚 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鈥檚 HPLE-LM Excipient products are known as 鈥榖est in class鈥� due to its high purity, performance, consistency and quality attributes.