Advanced Therapy Medicinal Products (ATMPs) also known as gene or cellular therapies are terms that describe medicines based on genes, tissues or cells intended for human use. There are various approaches and the European Medicines Agency defines the following:

• gene therapy medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant' genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources;


• somatic-cell therapy medicines: these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases;


• tissue-engineered medicines: these contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue;

All these biotherapeutics present some difficult problems to the QC testing laboratory, as they have a short shelf life and are produced in small quantities, personalized for the individual patient, the normal compendial testing approach is therefore not very practical. Here in this rapidmicrobiology.com special focus, we showcase some options available for getting fast microbiology results.

Find out from Dr Sylvanie Cassard, bioMérieux Healthcare how BioFire® can deliver Mycoplasma results in under 1 hour. Helena Windsor, Mycoplasma Experience tells us about the risks and international regulations concerning mycoplasmas in biotherapeutics, and with such rapid expansion in this field, what is the fastest way to get production up and running? Michelle Stafford, GE Healthcare LifeSciences explains how they can construct, assemble and fully fit out a factory-in-a-box ready for handover after qualification in just 18 months. Plus there are many other solutions presented below.

How Rapid Micro Biosystems Approaches Data Integrity

BioFire® Mycoplasma: A Cell and Gene Therapy Game-Changer ​

Testing Biotherapeutics for Mycoplasmas - the Risks and International Regulations

Rapid Sterility: Total Bacteria and Fungi Detection in just 3 Hours!

Managing Microbial Contamination Risk in ATMPs Manufacture  

CHAINBiotech’s Use of Whitley Workstations in Clostridium-assisted Drug Delivery 

Rapid Detection of Bacterial Contamination for Cellular Therapeutics

The Fastest Way to Expand Biotherapeutic Production Capacity

Rapid Mycoplasma Kit Qualified for Cell Therapy In-house QC

A New Automation Solution for the Production and Delivery of Cell and Gene Therapy

Terumo BCT's latest cell therapy technology, the FINIA® Fill and Finish System, is a first-of-its-kind device developed to help bring reproducibility and control to cell therapy manufacturing.

Quantifying Adeno-Associated Virus (AAV) Aggregation in Gene Therapy Delivery

Adeno-associated viruses can be used as vehicles for gene therapy, however viral aggregates may cause problems, a new applications study reports on how asymmetric flow field flow fractionation coupled with multi-angle light scattering and Ultraviolet detectors can quantify AAV aggregation.

RSSL Training: Biologically Derived Products - Testing and Manufacturing Challenges 5 and 6 Nov 2020, Reading, UK
Relevant to those who need to gain a better understanding of the challenges in GMP manufacture of biological products, the regulatory position of biological products and how GMP regulations are managing the rapid technological developments. Particularly those in Production, QC and QA working at Manufacturers and QC testing houses handling biologically derived products.