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Adapting to Fast-Emerging Medical Threats with Optimized Biotherapeutic Stability

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SelectScience® spoke to Rebecca Gentile, Senior Specialist in Quality, Vaccine and Biological Stability at Merck, about the future and current challenges of her work

20 Jun 2016
Lois Manton-O'Byrne, PhD
Executive Editor

Editorial article

SelectScience® spoke to Rebecca Gentile, Senior Specialist in Quality, Vaccine and Biological Stability at Merck,

Unlike chemical drugs, many biotherapeutics may be unstable due to their sensitivity to heat and light, as well as container materials or other components in the mixture. Ensuring long-term stability to optimize their therapeutic action is therefore an important part of vaccine development.

SelectScience spoke to Rebecca Gentile, a scientist at Merck, one of the largest companies involved in the commercial development of therapeutics, who is also giving a talk on 'Creating a Stability Budget to Support the Packaging and Distribution of Biological Products' at the 4th BioLogistics Summit in San Francisco, June 27-29.

Q: What are the current challenges in ensuring the stability of newly developed vaccines and biologics?

A: The products by default tend to not be particularly stable. Ensuring that the appropriate formulation and packaging is leveraged in the product design during development is a priority to being able to demonstrate appropriate stability for the commercial product. Designing stability studies to support the label storage condition and expiry, as well as supporting a stability budget for planned and unplanned time out of storage is important for managing the life cycle of the commercial product as well.

Q: What does the future hold for vaccine and biologics development?

A: I think faster design to meet emerging medical threats (Ebola, Zika virus) may become more common. Finding fast ways to optimize the program development will be critical, rather than leaving problems to be solved later after a first pass product is filed. Also, new platforms to establish more stable (possibly even room temperature) vaccines and biologics are intriguing and would enable improved delivery to more of the world’s population, especially in the developing world, as well as reduce shipping and storage cost and discard due to excursions.

Q: What new innovative projects or clinical trials have you been a part of and what are your day to day challenges?

A: Daily challenges include educating product teams as to the value of supporting the additional stability studies in Phase III development, prior to filing, to allow more flexibility to commercial product, as well as interpreting the stability data in a way that agencies will understand and accept.

Q: What other technology and products you would like to use in the future?

A: Development of lower cost shipping options for refrigerated products that maintain temperature ranges more reliably is always a benefit. Continuing to improve the design of the shippers themselves is beneficial in this area.

Learn more about biopharmaceuticals with our special feature.

What products do you use in your drug development research? Review them now to help other scientists around the world, and for the chance to win great prizes!

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Protein PurificationProtein purification is a vital step in drug discovery, therapeutics, biotech and life science research. The purification process typically involves subcellular or membrane protein extraction with cell lysis kits, separation of proteins from cell debris by filtration or spin columns, and the isolation of proteins of interest from other proteins and impurities with affinity purification (including fusion protein tags and antibody binding proteins A, G and L), immunoprecipitation or chromatographic methods, such as ion exchange, size exclusion and immobilized metal affinity chromatography. All purification methods come in multiple formats for your laboratory needs, including agarose or magnetic beads, resins, columns and filter plates. Find the best protein purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Shipping / PackagingPackaging is the technology of enclosing or protecting products for distribution, storage, sale, and use and the process and production of packages. Packaging is closely linked to Shipping and the preparing of goods for transport, warehousing, logistics, sale, and end use. Within the pharmaceutical industry packaging and shipping are used for transport, storage and logistics between Contract Research Organizations (CROs), Manufacturing and Clinical Trial companies. Packaging is also critical in the final production of a pharmaceutical product before market. Development SoftwareComputational techniques used in both the chemistry and biology aspects of drug development, for data acquisition, data analysis, processing and storage. Software is used for analysis of ADME results, toxicology, clinical trials and regulatory processes. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Scale-upScale-Up is generally defined as the process of transferring the results of the discovery phases of the drug discovery process, obtained on a laboratory scale, to the pilot plant and finally to production scale. Scale-Up uses reactors and pump systems as well as reagents, standards and buffers. Often Scale-Up is provided as a service by Contract Manufacturing Organizations (CMOs). EbolaThe Ebola virus outbreak in West Africa is the largest in history. Rapid diagnostic tests for this hemorrhagic fever are desperately needed, and companies are working hard to develop new point-of-care, RT-PCR and automated desktop Ebola kits and systems.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.

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