Pfanstiehl, a leading global provider of high-quality, injectable excipients, speciality cGMP bioprocessing components, and active pharmaceutical ingredients (APIs), is excited to announce the launch of its new high-purity, low-endotoxin, low-metals glucose (dextrose) product (CAS 50-99-7), developed specifically for upstream biologic production in commercial biopharmaceutical manufacturing. This new product ensures the highest quality, consistency, and safety, supporting critical protein production processes with unmatched reliability.
Why high purity, low endotoxin, and low metals matter in upstream biologic production
In biologic protein production, especially at the commercial scale, the quality and purity of materials used in the upstream process can significantly impact the final product’s efficacy, safety and regulatory compliance. Contaminants like endotoxins or trace metals can introduce major challenges, including reduced product yield, impaired protein function, and increased risk to patient safety.
- High purity: Pfanstiehl’s glucose is of the highest compendial grade, ensuring that it contains no impurities that could interfere with metabolic pathways or negatively affect protein expression. This purity reduces the likelihood of unwanted metabolic byproducts, enhancing overall process efficiency.
- Low endotoxin: Endotoxins can have a detrimental effect on production cell line health. High endotoxin levels can lead to stress responses in cells, reducing their viability and impairing their ability to efficiently produce proteins. This can result in lower protein yields and a decline in protein quality, which can compromise the effectiveness of the final biologic product. Pfanstiehl’s high-purity, low-endotoxin, low-metal glucose minimises these risks, ensuring a healthier cell culture environment that supports robust protein production while also meeting stringent regulatory requirements for endotoxin levels.
- Low trace metals: Even small amounts of trace metals can alter cell metabolism, lead to oxidative stress, and interfere with protein folding or post-translational modifications. Pfanstiehl’s high-purity, low-endotoxin, low-metal glucose helps avoid such issues by keeping trace metal concentrations below critical thresholds, contributing to higher product yields and ensuring that the quality of biologic proteins is maintained from batch to batch.
The essential role of glucose in biologic production
Glucose is a vital component in upstream biologic production, serving multiple functions to support cell growth, protein synthesis, and overall productivity. Key roles include:
- Primary energy source: Through glycolysis, glucose is metabolised into pyruvate, producing ATP and NADH. These molecules are essential for cellular energy supply, driving protein synthesis and maintaining cell viability.
- Carbon source for biosynthesis: Glucose provides carbon skeletons for the synthesis of amino acids, nucleotides, lipids, and other biomolecules that are critical for cell growth and protein expression.
- Regulation of protein expression and post-translational modifications: Adequate glucose levels influence gene expression and modulate metabolic pathways that determine the yield and quality of the target protein. It also affects glycosylation patterns, which are important for the activity and stability of many biologics.
Optimising upstream bioprocesses
Pfanstiehl’s high-purity, low-endotoxin, low-metal glucose is designed for use in fed-batch and other controlled feeding strategies, ensuring optimal nutrient supply without leading to byproduct accumulation, such as lactate or acetate, which can inhibit cell growth and productivity. Key benefits include:
- Consistency and reliability: The glucose is produced under strict ICH-Q7 cGMP conditions in the united states, adhering to the highest compendial standards (USP, EP, BP, JP, CHP), ensuring batch-to-batch consistency, a critical factor in biopharmaceutical manufacturing.
- Customisation of culture conditions: By adjusting glucose levels in feed strategies, production conditions can be tailored to maximise protein yield, minimise metabolic stress and enhance product quality.
- pH and osmotic stabilisation: Glucose helps stabilise pH levels in culture media and maintain osmotic balance, contributing to a stable environment for optimal cell growth and protein production.
Why choose Pfanstiehl’s glucose for your upstream biologic production?
Pfanstiehl’s high-purity, low-endotoxin, low-metal glucose (dextrose) offers unmatched quality and performance for upstream biologic feed applications. With stringent production processes and adherence to global pharmacopeial standards, this multicompendial glucose ensures the highest level of safety, purity, and consistency in biopharmaceutical manufacturing. It is specifically tailored for companies looking to optimise their bioprocesses, ensuring both high yield and product quality in therapeutic protein production.
Pfanstiehl’s high-purity, low-endotoxin, low-metal glucose (dextrose) cGMP is available now for biopharmaceutical and research applications. For more information, visit Pfanstiehl.com/en/