CMC, GMP & Manufacturing

Chemistry, Manufacturing and Controls (CMC) and GMP: upstream and downstream processing, bioreactors, purification, fill-finish, stability, CQAs and CPPs, and what it takes to release a batch.

Key terms & definitions

35 terms in this pack

AGGREGATION

Clumping of protein molecules; a key biologic quality concern

ASSAY

An analytical test measuring a product attribute like potency

BATCH

A single discrete manufacturing run

BIOREACTOR

Vessel where cells are cultured to produce the antibody

CGMP

The 'current' GMP standard the FDA actively enforces (acronym)

CHARACTERIZATION

Extensive analytical study defining a molecule's properties

CHROMATOGRAPHY

Column-based separation used to purify the antibody

COMPARABILITY

Showing product is unchanged after a process or site change

CPP

Critical Process Parameter whose variation affects a CQA (acronym)

CQA

Critical Quality Attribute kept in range to ensure quality (acronym)

DEVIATION

A documented departure from an approved procedure

DIAFILTRATION

Membrane step that exchanges buffer and concentrates product

DOWNSTREAM

Process phase that purifies the product after harvest

DRUGPRODUCT

The final formulated, filled dosage form; the 'DP' (two words)

DRUGSUBSTANCE

The active ingredient before formulation; the 'DS' (two words)

EXCIPIENT

Inactive ingredient in a formulation, like a buffer or sugar

FILLFINISH

Final step: filling drug product into vials and sealing (two words)

FORMULATION

Turning drug substance into the final dosed drug product

GMP

Good Manufacturing Practice, the quality rules for making drugs (acronym)

HARVEST

Separating cells from the product-containing broth

IMPURITY

Unwanted species that purification is designed to remove

LOT

A batch's unique production identifier

LYOPHILIZATION

Freeze-drying a product into a stable powder form

NONGMP

Material made outside strict quality rules, e.g., for early research

PURIFICATION

Removing impurities to reach the required product purity

RELEASE

QC testing that clears a batch before it can be used or sold

SCALEUP

Moving a process from small lab batches to commercial size (two words)

SHELFLIFE

How long a product stays within spec, set by stability data (two words)

SPECIFICATION

The list of tests and limits a batch must meet to be released

STABILITY

Studies (per ICH Q1A/Q5C) that set a product's shelf life

TECHTRANSFER

Moving a validated process to another site or CDMO (two words)

UPSTREAM

Process phase where cells are grown in bioreactors to make the antibody

VALIDATION

Documented proof a process consistently meets requirements

VIAL

The small container drug product is filled into

YIELD

How much product a manufacturing run actually produces