Decontamination processes in pharmaceutical isolators

Rubrik: Technik

(Treffer aus pharmind, Nr. 08, Seite 780 (2024))

Krebsbach T | Lehmann F

Decontamination processes in pharmaceutical isolators / Krebsbach and Lehmann | Decontamination processes · Krebsbach T, Lehmann F · SKAN AG
Isolator Aseptic Processing Decontamination Bioindicator Annex 1 Over the last 2 decades, isolator technology has gained a well-deserved and undisputed place in the pharmaceutical industry, both in the manufacture and quality control of sterile medicinal products. This is also reflected in Annex 1 to the EC GMP Guideline published in Aug 2022, which clearly recommends the use of barrier technology, as it significantly increases the protection of the product against potential contamination in the form of endotoxins/pyrogens, particles and microbial contamination caused, for example, by personnel, materials or the environment [ 1 ]. Consequently, Annex 1 of the EC GMP Guideline requires explicit justification for the use ...

Isolator for the CAR-T-Cell Therapy

Rubrik: Technik

(Treffer aus pharmind, Nr. 08, Seite 784 (2023))

Aldi S | Lehmann F

Isolator for the CAR-T-Cell Therapy / Aldi and Lehmann • Isolator CAR-T-Cell Therapy · Aldi S, Lehmann F · Allschwil (Switzerland)
Advanced therapy medicinal products (ATMPs) are fast-growing fields in the modern medicine and cell & gene therapies become a hot topic for pharmaceuticals and manufacturing industries. Cell & gene therapies were developed by scientists which improved basic research concepts and protocols to be used for clinical purpose, such as gene manipulations via viral transduction, specific phenotypic cell population isolation, and stem cell differentiation. Methodologies, immunology knowledge, and molecular biology approaches have been notably improved during the past 10 years, by the development of magnetic bead-based systems for phenotypic cell isolation, cancer antigen selection as well as clustered regularly interspaced short palindromic repeats -Cas9 nuclease (CRISPR-Cas9) ...

Advanced Aseptic Pharmaceutical Production in a Scalable Isolator

Rubrik: Reinraum

(Treffer aus TechnoPharm, Nr. 02, Seite 86 (2023))

Lehmann F | Bühler T

Advanced Aseptic Pharmaceutical Production in a Scalable Isolator / A Case Study · Lehmann F, Bühler T · SKAN AG, Allschwil (Switzerland) und Bausch+Stroebel Machine Company, Inc., Branford (USA)
Aseptic toxic isolator Modular fill-finish Small batch Advanced filling 100 % in-process-control Toxic/potent/high active The production processes in the pharmaceutical industry are increasingly changing in the direction of high-quality and highly specialized niche products [ 1 ]. Highly potent active pharmaceutical ingredients (HPAPIs) and Antibody Drug Conjugates (ADCs) for example are a new generation of highly active, pharmaceutical products, which are used for the targeted treatment of cancer. Some of these products require occupational safety measures that ensure compliance with occupational exposure limits below 100 ng/m 3 of air in the workplace [ 2 ]. Curia Albuquerque, NM/USA, is a pharmaceutical contract ...