Packaging
A glass act
Glass has been the most popular primary packaging choice for drug makers for centuries, a combination of its formulation compatibility and low permeability. But the choice of primary packaging can never be taken lightly, as Elly Earls discovers from Hanns-Christian Mahler, chief enablement offi cer at contract development and manufacturing organisation, ten23 health. He explains why decisions around packaging are just as important as the formulation and why he approaches pharmaceutical development from a design-thinking perspective.
P
ackaging may not be the aspect of pharmaceutical development that receives the most attention, but the choices manufacturers make about how their formulation is stored, presented and delivered to the patient are just as important as the combination of active ingredients and excipients. If the primary packaging isn’t compatible with the pharmaceutical or delivery device or if it isn’t sterilised or stored correctly, the hygiene, safety and functionality of the drug can all be compromised.
Glass has been the most popular primary packaging mode for pharmaceutical manufacturers for decades, or perhaps more accurately centuries. Apothecaries didn’t have access to affordable plastic containers, but they could avail themselves of the many benefits of glass as a packaging material. Its low permeability means most formulations can be stored safely and protected from elements such as microorganisms, oxygen
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and water, which could degrade the product and cause safety issues. In addition, unlike plastic materials, which contain various components that can migrate from the primary packaging into the product, leaching-related incompatibility is rarely an issue with glass. “The components that come from glass are typically alkaline earth metals including sodium, calcium and barium, which are generally not of any concern from a safety perspective,” explains Hanns-Christian Mahler, chief enablement officer at ten23 health, which supports pharma and biotech clients in developing, commercialising and optimising their sterile drug products.
Mahler previously held senior roles at Lonza, Roche and Merck and has published more than 120 manuscripts and co-invented more than 50 patents, many around primary packaging. “There will always be a formulation where there is not great compatibility with glass, for example if someone
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