Advaxia Biologics

Glossary

Glossary

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A
Adenovirus

Adenovirus is a type of virus belonging to the family Adenoviridae. It is a non-enveloped virus, meaning it lacks an outer lipid membrane. Instead, it has a sturdy protein capsid that protects its genetic material. Adenoviruses have attracted scientific interest due to their unique ability to efficiently deliver genetic material into target cells. Researchers have explored the use of adenoviral vectors in gene therapy and as vaccine carriers to trigger immune responses against specific pathogens or diseases.

AIFA

The Italian Medicines Agency (aifa.gov.it)

Antigen

Toxin or other foreign substance which induces an immune response in the body, especially the production of antibodies

C
Capsid

A capsid is the protein shell that surrounds and protects the genetic material (DNA or RNA) of a virus. It is a crucial component of the virus’s structure and is responsible for maintaining the integrity of the viral genome and facilitating its entry into host cells during infection.

Cell Banking

Cell banking refers to the process of storing and preserving cells, typically in a frozen state, for future use in various applications. This practice ensures a stable and consistent supply of viable cells that can be retrieved and used in research, biotechnology, medical therapies, and other fields.

cGMP

Current Good Manufacturing Practices. These are a set of regulations and guidelines established by regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to ensure the quality, safety, and consistency of pharmaceutical products, medical devices, and other healthcare-related products. Compliance with cGMP is mandatory for companies involved in the production and distribution of these products.

D
ddPCR

Digital Droplet Polymerase Chain Reaction. The ddPCR technique is an advancement of the traditional PCR method, which amplifies and detects specific DNA or RNA sequences. In ddPCR, the sample is partitioned into thousands of individual droplets, each containing one or a few copies of the target nucleic acid molecule. The partitioning allows for the analysis of each droplet as an independent reaction.

Downstream (Process Development) – DSP

DSP is a critical phase in biotechnology and pharmaceutical industries, which involves the purification, isolation, and processing of biologically derived products after their production through fermentation or cell culture. This phase comes after the upstream process, which focuses on the production and growth of the desired biological material (e.g., recombinant proteins, monoclonal antibodies, vaccines) using microorganisms or cell cultures.

E
EMA

European Medicines Agency

F
FDA

U.S. Food and Drug Administration

I
IB

Investigator’s Brochure

ICH

International Council for Harmonization

IMPD

Investigational Medicinal Product Dossier

IND

Investigational New Drug

ISO 14.001 Certification

Standard to improve environmental management

ISO 45.001 Certification

Standard for management systems of occupational health and safety

L
LAL

Limulus amebocyte lysate – in vitro assay used to detect bacterial endotoxins

Lysis

The disintegration of a cell by rupture of the cell wall or membrane

M
MCB

Master Cell Bank Production

MVB

Master Virus Bank Production

N
NGS

Next-generation sequencing

P
PCR Testing

Polymerase chain reaction

Phase I Clinical Study

Studies the safety of a drug using a group ofless than 50 participants

Phase II Clinical Study

Studies the efficacy of a drug using group of less than 100 participants.

Phase III Clinical Study

Compares the new treatment against existing treatment and studies potential side effects of group of hundreds of participants. Results then submitted to regulatory agencies.

Pilot Scale

Batches up to 20 to 50L scale size

Q
QMS

Quality Management System

S
(SOP)

Standard operating procedures

T
Toxicology

Study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants.

Transfection

Process of introducing nucleic acids into eukaryotic cells by nonviral methods to enable the study of gene function and protein expression in a cellular environment

U
Upstream

Maximizing cell-line productivity, adapting the cells to grow in dened media to meet your processing requirements

V
Viral Vector

A viral vector is a modified virus used as a delivery system to introduce specific genetic material into cells. The viral vector’s genetic material is replaced or modified with the genetic payload, which can be therapeutic genes, RNA molecules, or other genetic constructs. Once the viral vector infects the target cells, the genetic payload is integrated into the host cell’s genome or expressed transiently, leading to the desired biological effect.

Virus Seed Stock (VSS)

Viral seed stock refers to a sample of a specific virus that is used as the starting material for large-scale production of the virus for various purposes, such as vaccine development, research, or diagnostic testing. The viral seed stock is typically a well-characterized and purified preparation of the virus, and it serves as the master reference for generating larger quantities of the virus in cell cultures or other production systems.

W
WCB

Working Cell Bank Production

WVB

Working Virus Bank Production

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