Pfanstiehl, a leading global provider of high-quality, injectable excipients, speciality current good manufacturing practice (cGMP) bioprocessing components, and active pharmaceutical ingredients (APIs), is excited to announce the launch of its new high-purity, low-endotoxin, low-metals (HPLE-LM™) succinic acid, tailored for biopharmaceutical, pharmaceutical and other injectable applications. Pfanstiehl’s HPLE-LM™ succinic acid is commercially available for research & development through commercial manufacturing scale.
Succinic acid is a critical component used to buffer low pH formulations in antibody-drug-conjugates (ADCs) and other biopharmaceutical modalities. Pfanstiehl’s new HPLE-LM™ succinic acid (and Pfanstiehl’s HPLE-LM sodium succinate) is designed and engineered to meet the stringent quality requirements necessary for these critical buffering systems. Pfanstiehl’s high-purity, low-endotoxin, low-metals, excipient-grade succinic acid ensures exceptional purity levels while maintaining ultra-low endotoxin and metal content, making it ideal for use in advanced biologics, cell therapy, gene therapy, and other critical life science applications.
“We are thrilled to introduce this new addition to our high-purity, injectable-grade excipients and critical cGMP bioprocessing components portfolio,” said James Breckenridge, president and CEO of Pfanstiehl. “Our high-purity, low-endotoxin, low-metals succinic acid delivers the highest standards in quality and safety, which are essential for the biopharmaceutical and pharmaceutical sectors, including for next-generation ADC and other biopharmaceutical modalities. With this launch, we are helping to advance the performance of innovative therapeutics, ensuring patient safety and improving manufacturing outcomes.”
Key Features and Benefits:
- High purity/injectable-grade: Manufactured to meet the highest purity specifications, with rigorous controls to minimise impurities.
- Low endotoxin: Ultra-low endotoxin levels make it suitable for biologic manufacturing and applications requiring stringent contamination controls.
- Low metals: Stringent controls and proprietary processes ensure exceptionally low metal content, preventing interference in sensitive biological processes.
- Global cGMP compliance: Pfanstiehl’s facility adheres to global cGMP standards, ensuring consistent quality and regulatory compliance.
This latest product from Pfanstiehl underscores the company’s commitment to providing best-in-class solutions to its customers, supporting them in developing innovative therapies, and maintaining the highest safety standards for patients around the world.
For more information on Pfanstiehl’s high-purity, low-endotoxin, low-metals succinic acid or other best-in-class injectable-grade excipients, please visit our website at https://pfanstiehl.com/en/