Craftsman Bio Process key terms

A manufacturing method that uses living cells or their components, such as enzymes, to produce a desired product. It combines biological reactions with controlled engineering steps like mixing, heating, and purification.

All steps that come before product recovery, including preparing media, sterilizing equipment, growing cells, and running the bioreactor. Upstream work determines how much biomass or product the culture can generate.

The sequence of recovery and purification steps that turns a harvested culture broth into a safe, concentrated product. It typically includes cell separation, concentration, chromatography, and formulation.

A closed vessel engineered to support controlled growth of cells or enzymes, with systems for agitation, aeration, temperature, and pH. Operators monitor and adjust these variables to keep the culture productive.

The nutrient solution supplied to a culture, containing carbon sources, nitrogen, salts, vitamins, and trace elements. Its composition strongly affects growth rate, yield, and the profile of impurities.

Introducing a small, defined volume of viable cells into prepared medium or a bioreactor to start a culture. A consistent inoculum size and cell state make runs reproducible.

The staged series of progressively larger cultures used to build enough healthy cells to inoculate a production bioreactor. Each transfer is timed and monitored to keep cells in a vigorous growth state.

A process that destroys all viable microorganisms in equipment, media, or air to prevent contamination. Common methods include steam under pressure, filtration, and chemical agents.

A set of practices that keeps sterile materials free of microbial contamination during handling. It includes working in clean zones, using sterile tools, and minimizing open exposure.

The unintended introduction of unwanted microorganisms or particles into a culture or product stream. Contamination can reduce yield, alter product quality, and require a run to be discarded.

Supplying air or oxygen to a culture so cells can carry out aerobic metabolism. Too little oxygen limits growth, while too much can cause foaming and shear damage.

Mixing a bioreactor's contents to keep nutrients, gases, and cells evenly distributed. The stirring rate must balance good mass transfer against shear stress on sensitive cells.

The mechanical force created when fluid layers move at different speeds, which can damage cells or proteins. It is influenced by impeller speed, bubble size, and pump design.

The concentration of oxygen available in the liquid phase of a culture, usually measured as a percentage of air saturation. Control loops adjust airflow and agitation to hold it at a target setpoint.

A measurable variable such as temperature, pH, or feed rate that is monitored and controlled during a run. Parameters are held within defined ranges to keep the process consistent.

The target value that a control loop aims to maintain for a process parameter. Deviations from the setpoint trigger corrective actions such as heating, cooling, or adding acid.

A process input whose variation has a meaningful effect on a critical quality attribute. It receives tighter monitoring and control because exceeding its range can compromise product safety or efficacy.

A physical, chemical, or biological property of a product that must stay within a limit to ensure the required quality. Examples include potency, purity, and identity.

The point at which a culture is ended and its broth or cells are collected for recovery. Timing the harvest correctly maximizes product titer and minimizes degradation.

Separating solids from liquid by spinning the sample at high speed so denser particles settle. In downstream work it is used to remove cells or debris from product-containing fluid.

Passing fluid through a porous barrier to remove particles, cells, or microorganisms. It can clarify a process stream or sterilize a solution without heat.

A purification method in which molecules separate as they travel through a packed bed at different speeds. It is used to capture, polish, and remove impurities from a product stream.

Washing captured molecules off a chromatography column by changing the buffer conditions. The collected liquid, called the eluate, contains the purified product.

A solution that resists changes in pH when small amounts of acid or base are added. Buffers are used in media and purification steps to keep conditions stable.

The controlled document that records every step, material, and measurement for a production batch. It provides the traceable history needed for release and audit.

The regulatory framework of practices ensuring products are consistently made and controlled to quality standards. It covers facilities, documentation, personnel, and process control.

Any departure from an approved procedure, specification, or expected result during production. Deviations must be documented, investigated, and assessed for impact before product release.

A structured response that fixes the root cause of a detected problem and prevents it from recurring. It is tracked to closure with evidence that the fix worked.

A systematic investigation to identify the underlying reason a problem occurred, rather than just its symptoms. Common tools include the five-whys method and cause-and-effect diagrams.

A check performed during production to confirm that the process stays within defined limits. Results can trigger adjustments or stop a batch before it reaches final testing.

A documented requirement that a material or product must meet to be considered acceptable. It states the attribute, the test method, and the acceptance limits.

A laboratory test that measures a specific attribute, such as potency, concentration, or purity. Assays must be validated to show they are accurate and repeatable.

Documented evidence that a process, method, or system consistently produces results meeting predetermined criteria. It usually involves defined protocols, acceptance criteria, and repeat runs.

Demonstrating that equipment, facilities, or utilities are installed correctly and operate as intended. It is often staged as installation, operational, and performance qualification.

Comparing an instrument's readings against a known reference standard and adjusting it as needed. Regular calibration ensures measurements used for decisions are trustworthy.

A test result that falls outside an established specification limit. It requires a documented investigation before any decision to release or reject the material.

The formal decision, made by an authorized person, that a batch meets all requirements and may be used or sold. It follows review of records, test results, and any deviations.

The ability to follow a material or product through all stages of production and distribution using records. It enables rapid investigation and recall if a problem is found.