Raw Materials Used in Therapeutic Protein Production
Different types of ingredients and tools, which are collectively referred to as raw materials, are used to manufacture therapeutic proteins such as monoclonal antibodies (mAbs). All raw materials have specific quality attributes (measurable properties or characteristics that define overall quality). This interactive scrollable examines the raw materials that are used to manufacture a mAb, describes why raw material quality attributes are important, and explains how the standards for raw material quality attributes are established.
Topics
- ALXCollab
- cell culture media
- attribute science
- bioburden
- biologic
- biomanufacturing process
- bioreactor
- connector
- drug manufacturing
- drug product
- drug quality
- excipient
- filter
- mAb
- material identification
- monoclonal antibody
- pharmacopeia
- process development
- product container
- protein purification
- purification
- purity assay
- purity
- quality attribute
- raw material ingredient
- raw material specification
- raw material tool
- raw material
- resin column
- resin
- RMS
- single-use system
- solution bag
- sterilization
- therapeutic protein
- tool
- trace element concentration
- tubing