Current Perspectives on Stability of Protein Drug Products during Formulation, Fill and Finish Operations
Tóm tắt
Commercialization of protein‐based therapeutics is a challenging task in part due to the difficulties in maintaining protein solutions safe and efficacious throughout the drug product development process, storage, transportation and patient administration. Bulk drug substance goes through a series of formulation, fill and finish operations to provide the final dosage form in the desired formulation and container or delivery device. Different process parameters during each of these operations can affect the purity, activity and efficacy of the final product. Common protein degradation pathways and the various physical and chemical factors that can induce such reactions have been extensively studied for years. This review presents an overview of the various formulation‐fill‐finish operations with a focus on processing steps and conditions that can impact product quality. Various manufacturing operations including bulk freeze‐thaw, formulation, filtration, filling, lyophilization, inspection, labeling, packaging, storage, transport and delivery have been reviewed. The article highlights our present day understanding of protein instability issues during biopharmaceutical manufacturing and provides guidance on process considerations that can help alleviate these concerns.
Từ khóa
Tài liệu tham khảo
Wyatt P. J., 1991, Combineddifferential light scattering with various liquid chromatography separation techniques, Biochem. Soc. Trans., 19, 10.1042/bst0190485
Webb S. D., 2002, Freezing biopharmaceutical using common techniques and the magnitude of bulk scale freeze‐concentration, BioPharm, 15, 22
Lashmar U. T., 2007, Bulk freeze‐thaw of macromolecules‐Effect of cryoconcentration on their formulation and stability, BioProcess Int., 5, 44
Glaser V., 2005, Addressing stability of biological drugs, Gen. Eng. Biotechnol. News, 25
Singh S. K., 2007, Storageconsiderations as part of the formulation development program for biologics, Am. Pharm. Rev., 10, 26
Scott C.Formulation development: Making the medicine.BioProcess Int.2006 March 42–56.
Chang D.;Chang R.Review of current issues in pharmaceutical excipients.Pharm. Technol.2007.
Bee J., 2007, Abstracts of Papers, 234th National Meeting of theAmerican Chemical Society, Boston, MA, 2007
Stockdale D.Overview of aseptic fill/finish manufacturing.Am. Pharm. Rev.2004.
DeGrazio F. L., 2006, Focuson fill and finish: Parenteral packaging concerns for biotech drugs‐Compatibility is key,, BioProcess Int., 4, 12
Gabrielson J., 2007, Abstracts of Papers, 234th National Meeting of theAmerican Chemical Society, Boston, MA, 2007
MacKenzie A. P., 1976, Thephysico‐chemical basis for the freeze‐drying process, Dev. Biol. Stand., 36, 51
Carpenter J. F., 2004, Freezing‐ and drying‐induced perturbations of protein structure and mechanisms of protein protection by stabilizing additives, Drugs Pharm. Sci., 137, 147
Thurow H., 2004, Stabilization of dissolved proteins against denaturation at hydrophobic interfaces, Diabetologia, 27, 212, 10.1007/BF00273809
Allain L., 2007, Impact of package leachables on the stability of pharmaceutical products, Am. Pharm. Rev., 10, 38
Swift R.;Nashed‐Samuel Y.;Liu W.;Narhi L.;Davice J.Tungsten prefilled syringes and protein aggregation ACS National Conference 2007.
Harrison B.;Rios M.Big Shot: Developments in Pre‐filled syringes Pharm. Tech.2007.