Reliable Biopharmaceutical LLC Announces the Launch of Phytochol® for the Cell Culture Market
Reliable Biopharmaceutical LLC in partnership with Wilshire Technologies has launched Phytochol®, a vegetal-derived, semi-synthetic GMP Cholesterol for the Biopharmaceutical market.
The pharmaceutical industry is poised to enter a new paradigm in drug manufacture. Firmly grounded in biotechnology, protein-based pharmaceuticals offer the promise of achieving drug benefits far beyond anything yet accomplished by small molecule drugs. Virtually all protein-based drugs have one factor in common: they are the product of mammalian cell cultures. In turn, theses cell cultures share a common requirement: a cell medium that contains free Cholesterol.
The current market projection for protein-based pharmaceuticals is $50-$100 Billion annual. Given the restrictions imposed by western pharmaceutical regulators on the use of animal-based products, Phytochol® is a long-term viable solution for Animal Origin Free GMP Cholesterol.
With increasing frequency, regulatory authorities are cautioning that natural (i.e. animal-derived) cholesterol could pose health hazards to humans. Concerns about transmitting animal-based diseases to humans has made pharmaceutical and cosmetic companies increasingly concerned when using animal-derived raw materials like Cholesterol in their products.
Until recently, sourcing cholesterol from animals in countries where there was no reported cases of Bovine Spongiform Encephalopathy (BSE) was considered a solution to concerns regarding transmission of animal-based diseases. However, the recent occurrence of BSE in Japan, Canada, and the USA it suggests that geographic isolation is no longer an adequate safety barrier. The only certain way of eliminating the risk is to utilize a non-animal replacement for this versatile animal product.
To this end, two alternatives are marketed. The first is enzymatically–derived cholesterol, the implication being that such Cholesterol is the product of an in vivo microbiological synthesis. What is often not said is that the principal raw material for such a process is the residuals left from the processing of animal fats. The second, and the only true animal free method, involves semi-synthetic production from a vegetal precursor in which we leverage the fact that various readily available plant sources possess the requisite critical A, B, C, and D ring structure of Cholesterol. Utilizing natural extraction and synthetic-chemistry developed by Wilshire Technologies, we have launched the plant-derived (vegetal), semi-synthetic GMP cholesterol (Phytochol®) that is chemically and physically indistinguishable from the animal-based product. Additional information can be obtained by reviewing the FDA Drug Master File #27020 granted to Wilshire Technologies.
In addition to Phytochol®, RBC offers cGMP HEPES, MOPS, MES, and D-(+)-Galactose in convenient prepackaged development and manufacturing quantities on their NEW Catalog site. RBC also offers a Reaction Ready™ service to deliver any customized quantity in any packaged configuration to help our customers reduce waste and improve ease of manufacturing.
About Wilshire Technologies
Founded in 1997, Wilshire Technologies is an advanced technology development and transfer company headquartered in Princeton, NJ, which focuses on the development (isolation through scale-up and commercialization) of value-added, Animal Origin Free, vegetal-derived cGMP and non-cGMP products for the pharmaceutical, biopharmaceutical and cosmetic industries.
About Reliable Biopharmaceutical Corporation
Founded in 1968, RBC is an integrated developer and manufacturer of Active Pharmaceutical Ingredients (APIs) and High Purity Ingredients (HPIs) for pharmaceuticals and biologics. RBC has established a strong position as a leading developer and manufacturer of complex generic injectable APIs, cGMP Buffers, and cGMP Processing Aids. The company has a number of DMFs that have been accepted by Regulatory Agencies and has more in various stages of development. RBC's APIs are in leading generic injectable drugs that treat cancer, heart disease, hypertension, anxiety and other serious and life threatening illnesses. RBC HPIs are critical processing aids for many of the world's leading pharmaceutical and biotechnology companies.