Continuous Processing in Biomanufacturing: Considerations for Adoption and Case Studies in Biologic Development and Manufacturing
Summary: Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including…
read moreNew Techniques for Analytical “Bioassay” Cell Banking
Summary: The creation of a reliable bioassay requires dependable master and working analytical cell banks. In this interview with Pharmaceutical Technology, Michael Sadick, Ph.D., principal scientist at Catalent Biologics, explains…
read moreBiologics 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.
read morePackaging 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…
read moreEnsuring Success In Early Biopharmaceutical Formulation Development
Summary: Discover how a pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage.
read morePrefilled 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…
read moreContinuous 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…
read moreAdvances in Analytical Technology for Biopharmaceuticals
Summary: As the biologics industry grows, new analytical techniques are being developed to meet changing needs. This ebook discusses advances in analytical techniques for biopharmaceuticals.
read moreAn Emerging Playbook For Antibody Drug Conjugates: Lessons From The Laboratory & Clinic Suggest A Strategy For Improving Efficacy And Safety
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…
read moreThe 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…
read moreADC 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…
read moreReconstitution Of Formylglycine-generating Enzyme With Copper(II) For Aldehyde Tag Conversion
Summary: To further our aim of synthesizing aldehyde-tagged proteins for research and biotechnology applications, we developed methods for recombinant production of aerobic formylglycinegenerating enzyme (FGE) in good yield…
read moreInnovative Strategies To Maintain Product Integrity In Biologic And Biosimilar Clinical Studies
Summary: Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and…
read moreDesigning 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…
read moreViral 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…
read moreGenerating 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…
read moreNew 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…
read moreEnabling Higher Post Protein A Product Purity Using Novel Chromatographic Clarification
Summary: In the recent years, multiple optimizations and advances have been made to the classic antibody generation process to make it scalable, reproducible, and commercially viable. This article describes a strategy to get consistent highly pure products…
read moreWhat Role Do Biologics Play In The Fight Against Disease?
Summary: Jennifer Mitcham, SMARTag™ business development, Catalent Biologics, offers insight into the new generation of antibody drug conjugates and the increasing importance biologics play in the fight against disease…
read moreOptimizing Titer And Use Of A Specific Enzyme For Generating A Fully Processed Antibody
Summary: In Biologics, the market climate requires increasing speed to move the product to the next phase of development. Even before a product is proven effective in clinical trials, several decisions must be made…
read moreGet To Clinic Faster: Navigating Complex Biologics Through Development And Manufacturing
Summary: In Biologics, the market climate requires increasing speed to move the product to the next phase of development. Even before a product is proven effective in clinical trials, several decisions must be made…
read moreNovel 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…
read moreBiopharma 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…
read moreAntibody-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…
read moreAccelerating Method Transfer: Effective Automation Of Biological Assays
Summary: Bioassay automation offers ergonomic relief for scientists, consistent method execution, increased throughput, and reduced full-time equivalent expenditure. Importantly, successful automation programs allow unparalleled efficiency in method transfer to receiving laboratories. oderated Q&A roundtable…
read moreThe 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…
read moreContractors 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…
read moreMoving 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…
read moreLipid 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…
read moreSingle-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…
read moreAccelerating 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…
read moreBiosimilars: 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…
read moreGet To Clinic Faster: Navigating Complex Biologics Through Development And Manufacturing
Summary: With the increasing complexity of biologics and growing competition with players ranging from small start-ups to large pharma, an aggressive development timeline is required to bring your biologic drug to clinic faster…
read moreBiopharmaceuticals/ 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…
read moreDeveloping 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…
read moreAccelerating Biological Assay Method Transfer Through Effective Automation
Summary: Bioassay automation offers ergonomic relief for scientists, consistent method execution, increased throughput, and reduced full-time equivalent expenditure. Importantly, successful automation programs allow unparalleled efficiency in method transfer to receiving laboratories…
read moreEvolution 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…
read moreVirus Safety Of Biopharmaceuticals: Risk Mitigation During Upstream And Downstream Operations
Summary: From a virological safety standpoint, biopharmaceuticals have had an excellent safety record. This can be attributed to regulatory and industry initiatives that have worked synergistically…
read moreThe Challenges And Solutions For Non-invasive Macromolecule Delivery
Summary: Biologic therapy has revolutionized the medical treatment landscape. However, simplicity and ease of administration remains a challenge to achieve long-term patient compliance and optimal therapeutic outcomes. Given the high cost of biologic therapies…
read moreClinical 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…
read moreRecent Developments In ADC Technology: Preclinical Studies Signal Future Clinical Trends
Summary: The antibody-drug conjugate (ADC) field is in a transitional period. Here, experts from Catalent discuss how pre-clinical work is driving rapid evaluation of how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes…
read moreThe Perfect Partnership — Looking At The Growing Need For Strategic Partnerships
Summary: Strategic analytical partnerships are important in the development of new pharmaceutical products, especially biologics. Here, Michael Merges, Catalent Biologics, and Brian Fahie, Biogen, discuss the growing need for partners who can provide niche technologies to accelerate development projects…
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…
read more