Biomanufacturing: Process Development

In the age of biotechnology, making medicines at scale is a complex and multistage process. This cluster explores process development, looking at how a drug candidate goes from being a promising compound to a product that is manufactured and distributed to patients.   This is divided into three broad categories. In drug substance process development, experiments are performed to establish the process for making a drug substance on a large scale. In drug product process development, a drug substance is formulated into a final, marketable product that can be used by patients. In attribute sciences, a drug product’s quality attributes (measurable properties or characteristics of a drug that help to define its overall quality) are monitored.   Throughout this cluster, the development of monoclonal antibodies as therapeutic proteins will serve as an example for the individual steps involved in each stage of process development.

Topics

  • ALXCollab
  • active ingredient
  • antibody secretion
  • antibody structure
  • antibody synthesis
  • antibody
  • antigen
  • attribute sciences
  • automated inspection
  • biologic production
  • biologic protein
  • biologic
  • biological activity
  • biological function
  • bioreactor
  • blocking
  • cell culture
  • cell engineering
  • cell-based impurity
  • central dogma of molecular biology
  • chemical instability
  • chemical stability
  • chemical stress
  • chromatography
  • clinical development
  • clone
  • column chromatography
  • combination drug product
  • combination product
  • combined drug product
  • conformational instability
  • conformational stability
  • delivery
  • diafiltration
  • disulfide bond
  • dosage form
  • dosage
  • drug candidate
  • drug container
  • drug delivery device
  • drug discovery
  • drug dosage
  • drug efficacy
  • drug formulation
  • drug infusion
  • drug manufacturer
  • drug manufacturing
  • drug metabolism
  • drug product formulation
  • drug product process development
  • drug product stability
  • drug product storage
  • drug product
  • drug production
  • drug purity
  • drug quality
  • drug safety
  • drug solution
  • drug stability
  • drug storage
  • drug substance process development
  • drug substance technology
  • drug substance
  • drug transportation
  • engineered cell
  • excipient
  • fill/finish
  • flagging
  • formulated drug
  • formulation development
  • formulation
  • higher order structure
  • host cell
  • human antibody
  • human mAb
  • human monoclonal antibody
  • IgG antibody
  • IgG
  • immunoglobulin
  • impurity
  • lead candidate
  • levels of protein structure
  • liquid formulation
  • lyophilized formulation
  • mAb function
  • mAb structure
  • mAb variant
  • mAb
  • manual inspection
  • medicine
  • monoclonal antibody
  • parenteral
  • pharmaceutical drug
  • pool
  • process control
  • process development
  • process-related impurity
  • protein of interest
  • protein purification
  • protein secretion
  • protein stability
  • protein structure
  • protein synthesis
  • protein-based drug product
  • protein-based drug
  • protein-based therapeutic drug
  • protein-based therapeutic
  • purification operation
  • purity
  • quality attribute
  • raw material
  • route of administration
  • secreted protein
  • secretion
  • secretory pathway
  • therapeutic antibody
  • therapeutic drug product
  • therapeutic drug
  • therapeutic effect
  • therapeutic mAb
  • therapeutic monoclonal antibody
  • therapeutic protein production
  • therapeutic protein stability
  • therapeutic protein
  • type of formulation
  • ultrafiltration
  • viral filtration
  • viral inactivation
  • visual inspection