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For health services to be effective, drugs must be available, efficient, of high quality, safe and rationally used. Biologics and specialty drugs are advancing at a rapid pace simultaneously presenting challenges relating to manufacturing, fill operations and primary packaging.
Trends in Pharmaceutical Packaging
Pharmaceutical packaging has to support the trends taking place in the industry, which includes increased spending on flexible manufacturing, biologics, and self-administered drugs, along with increased investment in drug manufacturing. Majority of the drug in the development pipeline are highly complex biologics and specialty drugs that are typically produced in small batches which pushes manufacturers towards smaller and leaner manufacturing operations. Subsequently, the demand for ready-to-use (RTU) components and flexible filling technologies is rising.
Current Challenges with Primary Packaging
Challenges with primary packaging relate to the trends in the pharmaceutical industry. The packaging needs to support flexible manufacturing concepts (ready-to-use), the trend towards self-administration by being compatible with drug delivery devices and needs to be available in ever-better quality in growing markets.
Biologics require specialized packaging to limit the potential for drug/container interaction or contamination from extractable and leachable. This is highly relevant in consideration with low-fill applications. In low-fill applications, the vial is filled only to a small extent, meaning that a more significant percentage of the drug liquid comes in contact with this critical bottom region of the container.
Latest Advancements with New Technology
Technologies are assisting in improving drug stability and minimizing drug container interaction during drug shelf life. Next generation of vials is designed for sensitive biologics, high potent drugs or vaccines, and even low-fill applications. The vials are made of a Type I FIOLAX borosilicate glass— ensuring a notably improved resistance of the inner surface— with improved features and include the company's validated delamination controlled production process. A patented SCHOTT Delamination Quicktest offers results within 8-10 hours, allowing to determine a threshold value for the risk of delamination.
There are prefillable glass syringes designed to keep sensitive drugs stable over shelf life and making administration more convenient for patients. This is achieved through improved manufacturing processes leading to ultra-low tungsten and low adhesive residuals, as well as accurate dimensions for optimal device compatibility.
These advances in primary packaging will improve the safety and stability of biologic drugs, and combat the packaging challenges associated with biologics, highly potent drugs, vaccines, and so-called low-fill applications.