4.1.1 A druggable target is typically identified during research into a particular disease, after which the researchers must go about designing (“discovering”) an antibody against it. Antibody discovery technologies can generally be categorized as in vitro or in vivo approaches. Each type of approach has distinct advantages and disadvantages, which are heavily debated in the literature and scientific meetings.
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4.2.1 A wide range of human and other mammalian cells are routinely cultured in the laboratory for research and diagnostic purposes, yet biologics production of glycosylated proteins is mostly confined to HEK and CHO cells. This is a result of a few different factors. Innovators, especially small biotechs, need to minimize the unknowns in their already risky development programs wherever possible and prefer to stick with cells that have a well-established set of protocols for culture, scale-up, and testing. There are a wide range of off-the-shelf resources to support the CHO and HEK cell–based programs, such as optimized feed media and residual DNA and host cell protein testing kits.
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4.3.1 While techniques used to culture mammalian cells expressing recombinant protein products have not fundamentally changed over the past 30 years, there have been significant advances. The most significant of these, especially for mammalian cell culture, is the introduction and general acceptance of disposable single-use systems (SUS) that feature polymeric plastic product contact surfaces. In place of traditional stainless-steel bioreactors, processing vessels, hold tanks, and piping — which tend to be fixed and require cleaning between manufacturing batches using expensive clean steam and water — the industry has adopted SUS, which are generally more flexible and are disposed of after processing. This greatly reduces turnaround time between batches and increases facility throughput on a batch-per-year basis. It also eliminates the need to validate cleaning procedures.
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4.4.1 Advances in expression systems and output from upstream processing have placed significant strain on purification facilities and stimulated a range of technology developments in downstream processing. These technologies were largely developed to increase processing speed without compromising product quality and purity. Efforts also persist to replace expensive chromatography resins — particularly protein A, which is the predominant affinity chromatography resin used for purification of mAbs and derivative products.
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4.5.1 The highly complex nature of biopharmaceuticals places a significant burden on analytical methods and data to support discovery, development, regulatory approval, manufacture, and release. In addition to primary and secondary amino acid sequences and structure, posttranslational modifications — glycosylation, phosphorylation, deamidation, and so on — must all be closely monitored. Product-related impurities, host cell proteins, process impurities, and contaminating species must also be tested and identified. Raw materials must be properly identified; water and air quality must be maintained to rigorous standards; and cleanrooms and surfaces must be monitored for contamination. The stability of intermediate product during processing must be validated, as must the stability of the final product in both its drug substance and drug product forms.
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