Pfanstiehl Launches New cGMP-Produced, Parenteral Grade Arginine

As Pfanstiehl approaches its 100th anniversary in 2019, the company has launched a new high-purity, low-endotoxin, and low-metal L-Arginine to meet US Pharmacopoeia (USP), European Pharmacopoeia (EP), Japan Pharmacopoeia (JP), and Chinese Pharmacopoeia (ChP) standards.

Manufactured in the US under strict current good manufacturing practice (cGMP) and ICH Q7 compliant conditions, this is the first amino acid that Pfanstiehl has launched and it has others in development.

Amino acids have been known to exhibit both lyoprotective and cryoprotective effects similar to those of established stabilisers, such as sugars and/or polymers. However, they offer a greater range of chemical structures and physicochemical properties.  Their ability to prevent protein aggregation in both liquid and solid states, make them an attractive alternative as protein stabilisers for freeze drying.

L-Arginine has a chemical structure and physicochemical characteristics which are distinct among amino acids and can provide additional benefits to freeze-dried protein formulations with regard to stability.  Typically known as a key component in upstream cell culture, L-Arginine has also been utilised to help prevent aggregation when pharmaceutical formulations contain therapeutic proteins at relatively high concentrations.

As part of Pfanstiehl’s continual commitment to producing the industry’s highest purity, lowest endotoxin and lowest metals for bioprocessing components, the L-Arginine (A-170) specification includes ICH Q3D Elemental Impurity Data, which is backed by extensive product characterisation.  The product specification is also compliant with ChP.

Pfanstiehl’s specifications for the new L-Arginine help to provide product quality and consistency for better support with biopharmaceutical processing requirements.

Commercial material and samples from Pfanstiehl’s cGMP manufactured batches of L-Arginine are available now for customer qualification and manufacturing, along with a product profile.

Pfanstiehl develops high-purity, low-endotoxin, low-metal 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. The company has manufactured parenteral grade excipients for more than 50 years, and its excipients are critical formulation components in the majority of the top ten global blockbuster biopharmaceutical drugs that have been administered to thousands of patients around the world.

Pfanstiehl’s high-purity, low-endotoxin, low-metal excipient products are known for their high-purity, performance, consistency and quality attributes.

Pfanstiehl has built a strong reputation for supplying high-quality, cGMP-produced excipients from its US headquarters north of Chicago.

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