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Welcome! Our goal is to provide you with industry updates on a routine basis. Each update of "In The Know" will bring you news of industry presentations, conferences, and educational information.
We hope you enjoy Lyophilization Technology's (LTI) "In The Know". Look for our next quarterly update of the latest news!
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Recent Industry Contributions
"Residual Moisture Testing Methods for Lyophilized Drug Products"
Amy M. Bosch, Edward H. Trappler
Lyophilization is a way to preserve products that are unstable in the presence of water. Removing the water from the product decreases the potential for degradation by hydrolysis, and therefore improves the shelf life. Residual Moisture content is a critical quality attribute (CQA) of lyophilized finished products as it can have a significant impact on the stability of a lyophilized product upon storage in the dried state.
There are a number of different methods to measure residual moisture content in lyophilized materials.
Understanding the advantages and suitability of each method and its respective limitations surrounding the method aids in choosing the most appropriate method for testing. The goal of this paper is to review the common methods for residual moisture testing. The methods covered are Loss on Drying, Thermogravimetric Analysis, Karl Fischer Coulometric Titration, and Near Infrared Spectroscopy. Considerations when using each reach respective method will be presented. Compendial requirements in the USP, EU and JP will be highlighted as well.
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"Identifying TPPs and CQAs for a Lyophilized Parenteral Product"
Denise L. Miller,
Carrie A. Shults,
Edward H. Trappler
Quality by design (QbD) highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product's lifecycle.
A Target Product Profile (TPP) also referred to as Quality Target Product Profiles (QTPPs), is a summary of the proposed quality characteristics of a finished drug product. A TPP is a useful guide to bring focus to desired quality, safety, and efficacy. The goal of pharmaceutical development is to design and create a quality product and process to achieve delivery and performance, suitable for its intended use. A TPP forms the basis of design for the development of the product. The TPP is dynamic; to be updated as new knowledge is gained over the product lifecycle. The TPPs result from enhanced product knowledge and as such, aid in discussions with drug discovery, product development teams, clinical groups, manufacturers, as well as regulatory agencies. This allows for ease of risk-based decisions, and product and process improvements. To guide in the development process, potential Critical Quality Attributes (CQAs) are derived from the TPPs. Typical CQAs for solid dosage forms are aspects affecting purity, strength, and stability. Unique CQAs specific for a lyophilized product include aspects leading to solution and dried state stability, as well as reconstitution time, appearance of the constituted solution, and residual moisture. This is an essential application of quality by design principles and parallels those reflected in the Guidance for Industry Q8 (R2) Pharmaceutical Development. Among the benefits are increased focus during development and understanding of the unique lyophilized product quality attributes.
The result is an increased level of assurance that a product meets the needs of the end user and suitability for its intended use.
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"Parenteral Drug Manufacturing Challenger: It is mandatory to drive future progress and remove barriers to implementing innovative technology, focusing on a real application of quality by design"
Edward H. Trappler
There has been a significant expansion in the number of parenteral products. According to Genetic Engineering News (www.genengnews.com), of the 10 best-selling drugs in 2016, with sales totaling $60.9 billion, 7 were parenterals, of which 3 are self-administered. The top seller totaled $16 billion, and is available as a prefilled syringe and an auto-injector. The industry faces new and different challenges in moving from developing products to treat prevalent ailments, to less common conditions having orphan designation, to personalized therapeutics. In addition, the steady increase in parenteral products has led to the investigation and use of alternative drug delivery devices for ease of administration and improved patient compliance. These include a prefilled syringe and an auto-injector, or "pen". For products requiring a greater dose, large volume wearable injectors (LVWI) are under development as a new delivery system. The rapid growth demands an increased focus on better integration of product, quality, and manufacturing method development.
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"Comparison of Product Behavior During Lyophilization When Processed in Dual Chamber Syringes and Tubing Vials"
Michael S. Thomas
Product behavior and the influence of the lyophilization process parameters for material processed in a vial are generally well understood. Product behavior and process parameters suitable in a cartridge or, even furthermore in a syringe can be considerably
different for the same material processed in a vial. This often warrants unique assignment of the critical independent variables of shelf temperature, chamber pressure and
time to process with success and robustness against the challenges of the extraordinary device. The influence of the novel container/closure system of a syringe compared to the
more traditional vial and stopper combination was evaluated in this series of studies. Product behavior during processing and finished product attributes from both container types were compared.
Request a copy.
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Upcoming Industry Events
LTI wants to meet with you! Stop by our booths at any of the following events to discuss your lyophilization needs with one of our expert staff members. We look forward to meeting with you!
Outsourced Pharma Conference and Exhibition
July 18 - 19, 2018 * Philadelphia, PA
Learn, discuss, debate, question, form relationships... and do business. All with the feeling of one open community - ultimately in the service of patients around the world. Our participants consider Outsourced Pharma a place to learn about specific aspects of biotechnology and pharmaceutical outsourcing, interact with a cross-section of industry members, and generate new business opportunities.
LEARN MORE
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