Antibody development, scale-up, and mass manufacturing remain complex processes with many pitfalls and restarts.
Part of the challenge is that the skill sets needed for each of the three main steps — development, scale-up, and manufacturing — are considerably different, requiring the commercialization team to master diverse technologies and techniques. Further, the team is faced with decisions on outsourcing parts of the process or investing in in-house expertise and capital expenditures. Often, when a project has narrow performance specifications or tight launch deadlines, seeking out an experienced partner like MilliporeSigma is prudent. This talk covers the key steps in the modern antibody development process for diagnostic assays using advanced technology and discusses case studies in which MilliporeSigma's R&D and manufacturing teams solved some of the toughest challenges in antibody commercialization.
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