D-Galactose NF EP

Benefits of Pfanstiehl Multi-Compendial D-Galactose in Biologic Protein Production:

Mitigation of Lactate Accumulation

One of the primary challenges in large-scale cell culture for biologic protein production is the accumulation of lactate, a byproduct of anaerobic metabolism. Elevated levels of lactate can lead to a decrease in pH, causing stress to the cells and negatively affecting protein production. Galactose, when used as a carbon source, promotes oxidative metabolism, reducing the reliance on anaerobic pathways. This shift helps in minimizing lactate accumulation, maintaining optimal pH levels, and creating a more favorable environment for cell growth and protein synthesis.

Reduction of Ammonia Production

Ammonia, another byproduct of cellular metabolism, can be detrimental to cell viability and protein quality in bioprocessing. Excessive ammonia levels can lead to toxicity, affecting cell health and compromising the integrity of the produced proteins. D-Galactose metabolism has been shown to reduce ammonia production compared to other carbon sources, offering a more controlled and stable environment for cell cultures. This reduction in ammonia levels contributes to enhanced cell viability and overall protein production efficiency.

Increased Target Protein Production

By addressing the issues of lactate and ammonia accumulation, the use of galactose in biologic protein production ultimately leads to increased target protein yields. The optimized culture conditions provided by galactose as a carbon source create a more hospitable environment for cells to thrive, leading to improved cell growth and enhanced productivity. This, in turn, results in higher yields of the desired recombinant proteins, making galactose a valuable asset in the field of bioprocessing.

Modulate Glycosylation profiles (Galactosylation and Sialylation)

Supplementation of Pfanstiehl Multi-Compendial D-Galactose in cell culture media can help to modulate Galactosylation and Sialylation in recombinant Therapeutic glycoproteins. This may be particularly important during Biosimilars or Biobetters manufacturing where matching Glycosylation profile with innovator drugs or having improved efficacy than the innovator drugs is important. In some instances increasing therapeutic protein productivity can lead to decreased Galactosylation/Sialylation which can be mitigated by supplementing cell culture media with Galactose.