Commercial Release & Stability Programs
Evaluating the identity, strength, purity, potency, and safety properties of the drug substance and drug product upon release and over the course of its shelf life is critical for regulatory and marketing purposes. KBI provides a complete range of ICH stability conditions and cGMP test methods to assure the accurate profile of your biopharmaceutical product.
KBI excels in the performance of accelerated and long-term stability studies, from developing the protocol to delivering a technical document ready to be placed into your regulatory submission. KBI’s release and stability program experience includes products in all stages of development, from preclinical to commercial, and covers the full spectrum of biopharmaceutical products, such as antibodies, enzymes, fusion proteins, PEGlyated proteins, conjugates, protein vaccines, peptides, and olionucleotides.
Our services include:
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