DCAT Week

Attendees, exhibitors & solutions

Who this event is for

Industry trends

Key trends shaping this market and its wider industry.

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Hotel tiers

A range of accommodation options near the venue and across key areas.

Local transport

Get around the city with these convenient transport options.

Frequently asked

Glossary

1

DCAT

Drug, Chemical and Associated Technologies Association, the member-based organisation that runs DCAT Week; its membership spans pharmaceutical manufacturers, contract service providers, ingredient suppliers and allied technology firms.

2

API (Active Pharmaceutical Ingredient)

The biologically or chemically active substance in a finished medicine, before formulation with excipients.

3

Excipient

An inactive ingredient used to formulate a medicine, such as binders, fillers, coatings, solvents or preservatives.

4

Drug substance and drug product

Drug substance is the API as manufactured; drug product is the finished dosage form after formulation and fill-finish.

5

CDMO (Contract Development and Manufacturing Organisation)

A service company that develops and/or manufactures drug substance or drug product for other companies on a contract basis.

6

CRO (Contract Research Organisation)

A company that provides clinical trial, bioanalytical, preclinical or regulatory services on a contract basis.

7

cGMP (current Good Manufacturing Practice)

The regulatory quality system governing pharmaceutical production, covering facilities, documentation, validation and personnel.

8

Tech transfer

The documented process of moving a manufacturing method from one site or organisation to another, including scale-up and validation.

9

Scale-up

Increasing a manufacturing process from laboratory or pilot scale to commercial production volumes while maintaining product quality.

10

IND (Investigational New Drug)

A US FDA submission that allows a candidate drug to be tested in humans in clinical trials.

11

NDA and BLA

New Drug Application (small molecule) and Biologics License Application (biologic), the marketing authorisation submissions to the FDA.

12

QbD (Quality by Design)

A regulatory and development approach that builds product quality into the process through design space and control strategy rather than end-product testing alone.

13

Serialisation and track-and-trace

Unit-level product identification, aggregation and reporting systems required by regulators to secure the pharmaceutical supply chain.

14

Cold chain

Temperature-controlled storage and distribution of pharmaceutical products that require refrigerated or frozen conditions.

15

Continuous manufacturing

Production in an uninterrupted flow rather than discrete batches, using connected unit operations and process analytical technology.

16

Supplier qualification and audit

The documented assessment process, including questionnaires and site audits, that a manufacturer uses to approve a supplier.

17

Confidentiality agreement and due diligence

The NDA and information exchange package that precedes detailed technical and commercial discussions between pharmaceutical partners.

18

Alliance management

The function responsible for governing a long-term outsourcing or co-development relationship between two companies.