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EXPERT CONTENT

Downloadable expert content covering integrated, tailored solutions to accelerate your path to market.

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Biologics Drug Product Infocard

Summary: Learn how Catalent can formulate, fill, and package your product into vial, pre-filled syringe, or cartridge injectable formats that are ready-to-use for the patient or healthcare professional.

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Packaging Infocard

Summary: Catalent’s packaging operations in Bloomington, IN and Brussels, Belgium offer state-of-the-art, high-speed, automated equipment as well as configurable packaging and assembly rooms. Flexibility and adaptability in packaging are both important parts of Catalent…

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Prefilled Syringes & Parental Manufacturing

Summary: The global prefilled syringe and parenteral packaging markets are gaining momentum and growing quickly. Key players within the market are focusing their efforts to ensure products are of the highest quality, safe, and easy to use…

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Continuous Processing In Biomanufacturing

Summary: As the biologics industry continues to grow, biopharmaceutical companies are evaluating continuous processing as a potential means to improve efficiencies. There are many factors to consider when determining whether continuous processing should be adopted, and if so, what adoption strategy should be used…

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The Next Step In Homogeneous Bioconjugate Development

Summary: Bringing a new biologic drug to the market is a long and expensive process with R&D cycles that can span more than 15 years and cost over a billion dollars. Nonetheless the pharma industry is increasingly shifting efforts to focus on these types of compounds…

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ADC Development Using SMARTag™ Technology

Summary: Bioconjugates are an emerging class of biologics that combine the favorable properties of proteins, such as specificity and the ability to target distinct protein interfaces, with the advantages of synthetic small molecules, such as potency, bioavailability, and synthetic tractability. Early examples of bioconjugates include proteins linked to…

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Designing Optimized, Site-Specific ADCs

Summary: Antibody-drug conjugates have provided a breakthrough in targeted medicines but ways of increasing their stability and efficacy are still required. Historically, the technologies used to build these two approved products result in a heterogeneous milieu of conjugates…

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Viral Clearance For Biopharmaceutical Downstream Processes

Summary: Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies…

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Generating Aldehyde-Tagged Antibodies

Summary: This article is a selection of articles published in BioMed Central Ltd., giving overview on the ability to site-specifically conjugate a protein to a payload of interest has found widespread application in basic research and drug development…

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New Ideas For Antibody-Drug Conjugate Design

Summary: This article is a selection of articles published in The Scientist, giving overviews on new ideas for antibody-drug conjugates designs so oncologists can aim a chemical payload at any cell for which they can identify a specific antigen, such as the HER2 receptor on breast cancer cells…

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Novel Analytical Techniques For Monoclonal Antibodies

Summary: With the rising interest in biopharmaceuticals, drug developers need to quickly understand and evaluate the binding of therapeutic antibodies to Fc receptors. In this interview with Pharmaceutical Technology, Michael Sadick, Ph.D., and Dan Papa, Ph.D., of Catalent Biologics, talk about a new analytical testing panel…

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Biopharma Manufacturing Trends

Summary: As pharma companies look more and more to biologics for their next potential blockbusters, they must face the challenges surrounding these products’ scientific complexity and sophisticated development…

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Antibody-Drug Conjugates – Where Are We Now?

Summary: In October 2015, during CPhI World Wide in Madrid, Spain, Oncology Tube from InPress Media Group, LLC. asked experts from Piramal Pharma Solutions, Carbogen Amcis and Catalent Biologics about challenges in the manufacturing of ADCs and how they see the market for ADCs evolve…

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The Ever-increasing Attraction of Biologics

Summary: The field of biologics promises targeted treatments for a range of conditions. For the promise of many of these therapies to become a reality, however, technological challenges must still be overcome, with many exciting novel treatments currently on, or making their way to, the market. This article published in Chemistry World discusses…

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Contractors Take On The Challenge Of Complex Molecules

Summary: The global pharmaceutical analytical testing outsourcing market could reach ~$10 billion in the next decade. Read the latest Drug Development & Delivery report highlighting how the leading service providers are prepared to provide analytical and bioanalytical methods that address the growing market…

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Moving A Complex Protein From Development To Large-Scale Clinical Production

Summary: The number of more complex biopharmaceuticals in development continues to increase. These include molecules like virus-like particle vaccines, proteins that require cleavage, or other additional post-translational modifications not typically performed by CHO cells, and more recently, numerous different multi-specific antibody platforms…

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Lipid Based Systems For Oral Peptides

Summary: Applying clinical supply management expertise to overcome inventory challenges for a complex, global study. A CRO customer and clinical sponsor both lacked an unblinded supply management role to oversee Interactive Response Technologies platform (IRT) supply strategies and monitor clinical supply…

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Single-Use Bioreactors Pose E&L Challenges

Summary: Read the recent roundtable Q&A published in BioPharm International featuring biopharma executives discussing the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process…

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Accelerating Biologics And Biosimilar Development

Summary: Get to know how Catalent’s scientists have utilized ambr 15® as a micro-scale model for a synergistic clonal and process screen to identify the master cell bank candidates. Using this multi-layered approach, early in the development process significantly improves selection of top clones while shortening the overall timeline…

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Biosimilars: Getting Cheaper Biologics To The Market

Summary: The opportunity for new antibody biosmilar products is clear. By the end of this decade key patents currently protecting five monoclonal antibodies, each with sales in the neighborhood of a billion dollars a year will have expired, and companies are queuing up for a piece of the market…

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Biopharmaceuticals/ Biosimilars Roundtable, APR 2017

Summary: The biopharmaceutical market has seen incredible growth. American Pharmaceutical Review conducted industry round table with experts to share their opinion on the market drivers for growth, limiting factors and critical issues. Read the article to get insights on developing and marketing biopharmaceutical…

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Developing Site-Specifically Modified ADCs Using A Chemoenzymatic Approach

Summary: Antibody-drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development. This webinar hosted by Elsevier’s Drug Discovery Today presented novel protein modification platform and its application…

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Evolution Of Biomanufacturing Facilities

Summary: Advances in single-use bioreactor technologies offer rapid development pathways when combined with creative upstream process development strategies. When aggressive program timelines are required, the application of multiplexed conditions coupled with smart CMC decisions that maximize yields…

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Clinical Trial Supply Strategies For Biosimilar Studies

Summary: The use of biosimilars in clinical trials is on the rise. Often tightly controlled or in short supply, sourcing the necessary drugs can be challenging. Given the variability of biosimilars, studies using these products are particularly at risk for supply-related delay and cost overruns unless proactively managed from the beginning…

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Optimized Antibody Drug Conjugate Development

Summary: One of the current challenges with existing ADCs is the difficulty in creating conjugates with a uniform drug to antibody ratio and consistent payload placement on the antibody, both aspects which are paramount in creating consistent and predictable therapies…

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