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IDT Biologika GmbH sell "Drug Substance Manufacturing"

Basic Information

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Trade Type

Sell

Product Name

Drug Substance Manufacturing

Manufacturer(s)

Specifications

  • Purity: Drug substance released against validated purity specifications confirmed by analytical testing across BSL 1/2 viral and mammalian manufacturing platforms
  • Assay: Potency/content assay confirms consistent titer for clinical (Phase I-III) and commercial drug substance batches
  • Impurity Profile: Process- and product-related impurities (e.g. host cell protein, residual DNA) monitored throughout MCB/WCB and MVB/WVB manufacturing

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