Requirements for the production of highly active substances
In biopharmaceutical manufacturing, the trend is towards the production of new oncology products such as ADCs (antibody drug conjugates) or in the field of regenerative medicine such as genes and immunotherapies. Most of these pharmaceutical products are combination products that also contain a highly active substance. These highly active substances require a new form of employee protection [...]
Process safety through correct glove management
Gloves are currently still the most proven option for manipulation within isolators, barriers and other systems. However, they also pose the greatest risk to the integrity of these applications. Incorrect handling, poor maintenance or inadequate monitoring can result in leaks through which bacteria and germs can enter. It is therefore important to have a suitable glove management program [...]
Flexible aseptic pharmaceutical production of small quantities
A large number of active ingredients in biopharmaceutical production, especially for oncological applications, are antibody drug conjugates. Especially in the field of gene and immune therapies, smaller batch sizes down to patient-specific quantities of 1 are produced, which must be prepared efficiently on an industrial scale. The presentation shows a variably adaptable machine and isolation concept with executed [...]
Modern laboratory isolators for safe aseptic processes
The requirements for safe aseptic processes in the laboratory are becoming more and more stringent. In addition to carrying out sterile test processes - also with toxic products - in isolators as the established state of the art, new developments and technologies will be presented. These advances help to further improve the safety and efficiency of aseptic processes in the laboratory. The presentation [...]
Components of a modern sterile test isolator
The sterility test is part of the manufacturing process for parenterals. The GMP guidelines also prescribe this test. More than 50 years of know-how have gone into the development of the SPECTRA isolator to ensure a highly reliable and ergonomic process flow for the operator. With its many years of experience and technological progress, it helps to ensure the quality [...]
Product and employee protection with economical isolators
Isolator technology is always preferable to conventional cleanroom technology when there are stringent requirements for occupational safety or occupational safety in combination with absolute product protection. Isolator technology was initially primarily used to protect people from hazardous products, but has been expanded and optimized over time to provide product and personal protection, e.g. in [...]
Modular applications for the production of highly active substances
The future will bring a larger number of active ingredients that need to be produced in smaller quantities, right down to the patient-specific quantity of 1, which must be prepared efficiently on an industrial scale. Due to the increasing variety of active ingredients and the need to produce them in smaller quantities, it is crucial to develop efficient and adaptable production processes. The presented machine and [...]
Fast-track realization of a SiC wafer production factory
STMicroelectronics' (ST) competence center for power semiconductors is located in Catania, Sicily. Research, development and production of silicon carbide (SiC) substrates are combined there in cooperation with research institutes, universities and suppliers. Valtria is currently supporting ST in the rapid construction of an integrated clean room production facility for the manufacture of SiC-based raw and epitaxial wafers, with the aim of increasing ST's supply [...]
Overcoming challenges in the production of ATMPs
As cell and gene therapy continues to advance in modern biomedical research, the demand for advanced cell therapy procedures is increasing. The corresponding manufacturing processes rely on strict cGMP requirements for an aseptic environment to safely prepare and process sterile therapy products with the highest integrity, including CAR T-cell immunotherapy as well as platelet-rich plasma or mesenchymal stem cell therapy treatments. Given the [...]
Ready-engineered solutions under time pressure for market launch
Various innovative, aseptic-toxic filling concepts are presented in which the filling line merges with the isolator and is viewed as a single unit. he development of the various innovative, aseptic-toxic filling concepts focused on optimum operability, employee protection and cleanability. These concepts seamlessly integrate the filling line with the isolator to form a single unit. This ensures efficient and safe handling [...]