Challenges for cell-based medicinal products from a pharmaceutical product perspective

D Jere, AS Sediq, J Huwyler, I Vollrath… - Journal of …, 2021 - Elsevier
Advanced therapy medicinal products (ATMPs), such as somatic cell-therapy medicinal
products or tissue-engineered products for human use, offer new and potentially curative …

[HTML][HTML] A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

C Capelli, S Frigerio, D Lisini, S Nava, G Gaipa… - Cytotherapy, 2022 - Elsevier
Background aims Advanced therapy medicinal products (ATMPs) are novel drugs based on
genes, cells or tissues developed to treat many different diseases. Stability studies of each …

Leakage Dynamics of Glass Bottles on Container Closure Integrity Testing: Influence of Different Laser-Drilled Microhole Geometries

W Han, X Duan, J Wu, L Jiang, H Wu, Z Chen - Journal of Pharmaceutical …, 2023 - Elsevier
Container closure integrity testing (CCIT) is a critical step in ensuring package integrity and
providing feedback on package designs. In practical applications, CCIT methods, namely …

Industry perspective on a holistic container closure integrity approach to parenteral combination products

K Wuchner, HC Brown, F Canal, D Bonvin… - European Journal of …, 2024 - Elsevier
Biologics are being developed more and more as parenteral combination products with drug
delivery devices. The maintenance of sterility is imperative for such medical devices …

Comparing physical container closure integrity test methods and artificial leak methodologies

SS Peláez, HC Mahler, C Herdlitschka… - PDA journal of …, 2019 - journal.pda.org
The sterility of drug products intended for parenteral administration is a critical quality
attribute (CQA) because it serves to ensure patient safety and is thus a key requirement by …

Container closure integrity testing of prefilled syringes

SS Peláez, HC Mahler, A Matter, A Koulov… - Journal of …, 2018 - Elsevier
Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems
(CCSs) for injectable drug products when facilitated or self-administration is required …

[HTML][HTML] Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions

J Baseggio, A Zverev, O Pinato, A Vico… - Journal of …, 2023 - Elsevier
Abstract Development of novel pharmaceutical drug modalities has created a need for
frozen storage and transportation. Accurate and easy assessment of container closure …

A Road Map to GMP Readiness for Protein Therapeutics–Drug Product Process Development for Clinical Supply

R Liebner, S Altınoğlu, T Selzer - Journal of Pharmaceutical Sciences, 2022 - Elsevier
Biopharmaceuticals for human use present unique challenges during manufacturing,
storage, shipment, and administration. Not all drug product process development aspects …

Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)

S Aliaskarisohi, M Hogreve, C Langlois… - PDA Journal of …, 2019 - journal.pda.org
An aerosol microbial ingress test was specifically designed and used to create a predictive
model in order to determine the maximum allowable leakage limit (MALL) of single-use …

Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing

P Ulrich, G Blaich, A Baumann, R Fagg, A Hey… - Regulatory Toxicology …, 2018 - Elsevier
Biological drugs comprise a wide field of different modalities with respect to structure,
pharmacokinetics and pharmacological function. Considerable non-clinical experience in …