Proteins as Key Reagent
Key Reagent proteins are classified by their requirement for a production grade standard that lies between Research-Use-Only and In-human use. At LakePharma we offer the Bioprocessing Grade (BPG) production standard which meets our client's requirement for a higher grade of quality while not requiring fully cGMP production standards. Material produced under BPG are not treated as Drug Substance nor Drug Product because they are not directly applied to human patients. Examples include growth factors for cell culture media, protein reference standards in diagnostic kits, and enzymes used in certain bioprocesses. Because they are key reagents, their product quality and consistency is critical and as such, they often need to be manufactured under GMP or high quality system.
LakePharma offers end-to-end solutions for Proteins as Key Reagent, from engineering to development to manufacturing. The company offers several protein production platforms: bacterial expression, yeast expression, baculo expression, and mammalian expression. Process development and GMP or BPG manufacturing can be performed in LakePharma Hayward (CA) or LakePharma Hopkinton (MA).