Focusing on Biopharmaceutical Stability Research and Promoting the High-quality Development of the Biopharmaceutical Industry in China
Over the past decades,biopharmaceuticals,including recombinant proteins,antibody-based therapeutics,vaccines,nucleic acids,and cellular and gene therapies,have become the focus and future directions of the pharmaceutical industry worldwide.However,biopharmaceuticals are usually of only marginal stability and are prone to chemical and physical degradations,affecting their safety and efficacy.The solution of biopharmaceutical stability issues requires multidisciplinary collaborations among different fields,including basic mechanism study,process development,formulation development,manufacturing,and quality analysis,etc.To facilitate the understanding of the current status,future directions,and novel techniques for the biopharmaceutical stability research,the special Biopharmaceutical Stability Research column is established to invite well-known experts from industry,academia,and regulatory authorities to submit innovative and application-oriented articles in the biopharmaceutical stability areas.The articles published in this column cover major areas related to the biopharmaceutical stability research and give new ideas and strength for the biopharmaceutical development,promoting the high-quality development of the biopharmaceutical industry in China.
biopharmaceuticalsstabilityantibody-based therapeuticsadvanced therapyquality studyformulation development
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