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Extractables and Leachables Studies

By Matthew Woods

March 23, 2023

Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.

Cybersecurity Threats

By Renee Welsh

March 17, 2023

Organizations today are far more vulnerable to cyber threats due to the digital information and technology that are so heavily integrated into the daily workplace. The attacks themselves, which target both information and critical infrastructure, are becoming far more sophisticated.

Vials, stoppers & seals compatibility studies

By Jennifer Roark

March 09, 2023

Advanced therapies are rapidly becoming a reality, targeting unmet patient needs and treatments for diseases with limited therapeutic options. Some advanced therapies, such as gene therapy and mRNA, require frozen storage due to their fragile nature at ambient temperature, putting unprecedented expectations on the vial-stopper-seal combination to maintain container closure integrity (CCI) during storage at low temperature conditions. The quality, patient safety, and high value of these therapeutics can be jeopardized if the chosen vial-stopper-seal combination doesn’t maintain a sterile barrier from when the drug is packaged through to administration to the patient. During cooling from ambient temperature to temperatures below -80°C, packaging components such as glass vials, elastomeric closures, and aluminum seals exhibit contraction and changes in physico-mechanical properties. These changes in material properties and component dimensions may affect their ability to maintain CCI, resulting in the formation of transient leaks.

Success Story of Pharma-Gummi with Founder Hans Wimmer

By Hans Wimmer

March 01, 2023

The idea of establishing a rubber manufacturing company was born during a visit by the purchasing manager of the penicillin factory, Chemie Grunenthal in Stolberg. He asked whether I could produce rubber stoppers for penicillin bottles. I did some research and realized rubber stoppers were needed for lots of different types of medicine and there wasn’t currently a company specializing in this field.

Story of SmartDose® with Team Member, Scott Young, West Pharmaceutical Servicess, Exton.

By Scott Young

February 22, 2023

I’ve worked at West for 28 years. I lead our Venture Group, Global Labs, and Data Science Team; I’ve spent most of my career in R&D. There’s an expectation from our customers that West will lead the way in developing new products. Ones that are going to be better for patients, easier to use and more cost efficient for the health system. That expectation drives a lot of the R&D work we do.

Advantages of Flow Imaging over Light Obscuration in particulate characterization

By Mary Tan

February 16, 2023

The development of a drug product is an arduous and intricate process. Besides ensuring the sterility and effectiveness of the final product, it should also be as free of particles as possible. In protein-based pharmaceuticals, aggregates may form over time and are mostly detrimental to product quality, as they can affect the efficacy, potency, clinical safety, and immunogenicity of the product.1-3 Protein aggregates are considered a type of particulate matter (PM), and it is important to minimize their occurrence, as well as to quantify the PM for ensuring the quality and safety of the drug products.