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…
Enabling 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…
What 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…
Optimizing 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…
Get 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…
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…
Accelerating 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…
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…
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…
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…
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…
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…
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…
Get 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…
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…
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…
Accelerating 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…
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…
Virus 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…
The 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…
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…
Recent 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…
The 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…