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Lyophilization, commonly known as freeze-drying, stands as a pivotal process in the pharmaceutical industry, particularly within the expanding field of biopharmaceuticals. As a rapidly growing sector, biopharmaceuticals, including monoclonal antibodies (mAbs), have revolutionized the treatment landscape for various diseases. The inherent instability of protein drugs in aqueous solutions necessitates alternative formulations, with lyophilized powders for injection emerging as the preferred dosage form due to their ability to ensure product stability.

The lyophilization process involves the removal of water from a product by sublimation after freezing, providing a solution to the instability challenges posed by the large molecular weight and sensitivity of biopharmaceuticals. While acknowledged for its efficacy, lyophilization is a resource-intensive endeavor, both in terms of time and energy consumption. Consequently, the pharmaceutical industry is actively engaged in optimizing this process, exploring aggressive conditions and refining formulation parameters to reduce primary drying time and associated costs.

The industry's focus on biopharmaceuticals is underscored by the anticipated compound annual growth rate of 8.6% in the global biopharmaceutical market, reaching USD 390 billion by 2024. Monoclonal antibodies, constituting a quarter of this market, exemplify the transformative impact of biopharmaceuticals on disease treatment. The advent of biosimilars, driven by patent expirations, further propels the proliferation of protein drugs.

As the demand for biopharmaceuticals continues to surge, so does the need for efficient lyophilization processes. The incorporation of drug-specific excipients, such as protein stabilizers, surfactants, buffers, and bulking agents, emerges as a critical aspect in optimizing lyophilization. Moreover, the transition from intravenous to subcutaneous administration introduces new challenges, demanding innovative solutions like viscosity reducers to address issues related to high concentrations, viscosity, solubility, injectability, and reconstitution time.

A major contribution to the quality of the lyophilized product comes from the primary containment system, i.e., the glass vials, rubber stoppers and seals. Maintaining the required dryness of the product is realized by the container closure integrity (CCI) of the system which can only be ensured with carefully selected components that offer a proper dimensional and structural fit. Additionally, the elastomer formulation should have an acceptably low moisture water vapor transmission rate (MVTR) to minimize moisture permeability. At the end of the cycle the vials are closed by lowering the lyophilization shelves and thus pushing the stoppers firmly onto the vial. Here, stoppers could potentially stick to the shelf causing the entire vial system to be elevated when the shelf is lifted again. Often enough, this results in broken vials, which entails a lengthy and cumbersome cleaning process. One solution here is to use chemically strengthened glass vials that are more breakage-resistant as compared to standard borosilicate glass vials as they are currently widely used on the market.

This webinar will take you through the entire selection process for primary packaging components for lyophilization and will provide aspects to consider for all relevant attributes.

Dr. Bettine Boltres, Director Scientific Affairs & Technical Solutions, Glass Systems

Dr. Bettine Boltres

Director Scientific Affairs & Technical Solutions, Glass Systems

As Director Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Bettine is an active member of the USP Packaging and Distribution Expert Committee, the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). She is Convenor of the ISO Working Group 4 (Elastomers) and member of the Working Group 2 (glass). Additionally, Bettine is on the PDA Board of Directors and in 2015 she published the book “When Glass Meets Pharma”, which builds the bridge between glass for pharmaceutical primary packaging and drug substances. Dr. Boltres is a (bio)chemist by training, receiving a diploma in chemistry from the university of Frankfurt, Germany and a PhD in biochemistry from the university of Cologne, Germany.
D. Neal Higgins, Consultant Advisor, West Biologics Team

D. Neal Higgins

Consultant Advisor, West Biologics Team

With over 30 years of experience in parenteral drug manufacturing, drug product development, container closure and delivery device systems Neal is a valuable subject matter expert in multiple disciplines. Neal is a published author and speaker and has previously served on USP expert committees for both elastomers and glass. Neal joined West after his retirement from Eli Lilly & Company in 2018. At Lilly, Neal held multiple positions over the years and retired as the R&D global system lead engineer for vial systems. At West, Neal provides expert consultation both internally and for our customers, covering multiple topics including root cause analysis, design controls, contamination control strategy, risk management, vial containment, functional testing of materials and process engineering applications.