Biologics Analytical Services Stand-alone GMP and Non-GMP Analytical Solutions for Large Molecules
From pre-clinical testing through post-approval release and stability, Catalent provides customized, stand-alone solutions throughout the drug development process.
Strategies for Testing Host Cell Protein
Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke with…
Frontiers in Binding Assays and Bioassays
Summary: Bioassays and binding assays play a critical role in ensuring product quality, safety and efficacy.
From Basics to Best Practices: Exploring Bioassays and Binding Assays
Summary: Analytical testing for biologics is evolving rapidly as new protocols become available and companies seek to expedite current methodologies.
Strategies for Testing Host Cell Proteins
Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke…
Infographic: Bioassays and Binding Assays
Summary: Download the infographic to learn more about the latest cell-based bioassays and binding assays with an emphasis on their applications in the industry.
Strategies for Successful Transition of a Biologic Assay
Summary: Patient centricity has always been at the heart of the pharmaceutical industry. With rising costs of drugs and healthcare, there has been…
Quantification and Characterization of Polysorbate-80 in Protein Formulations
Summary: In this article, Luke Deters, Director of Biologics, discusses an appropriate method for quantification and characterization of polysorbate-80 (PS-80), a commonly-used, but highly-heterogenous, surfactant…
Regulatory Support
Summary: Our regulatory team completes over 150 agency submissions each year, supporting all stages of the product lifecycle. We assign a dedicated regulatory professional to each of our clients…
Catalent Biologics | Analytical
Summary: Your Strategic Partner for Biologics Development & Supply. As your trusted partner for tailored biologic solutions, we can help to bring your product…
Catalent Biologics | Upstream Development
Summary: Your Strategic Partner for Biologics Development & Supply. As your trusted partner for tailored biologic solutions, we can help to bring your product…
OneBio Suite: Integrated Biologics Development, Manufacturing and Supply
Summary: OneBio™ Suite provides integrated biologics development, manufacturing and supply with a single solution from cell line development through clinical supply. OneBio Suite is designed…
A Brief Evaluation of the Impact of Thermal, Shear, and Light Stress on Adalimumab
Summary: The propensity of a protein to degrade under stress can vary widely among proteins and is important to understand in pharmaceutical development. A model protein, adalimumab, was tested by a limited…
Multidimensional Evaluation of mAb Degraded Under Light, Shear and Thermal Stress Conditions
Summary: This poster evaluates the degradation of a therapeutic mAb, Adalimumab, resulting from light, shear and thermal stress. Degradation was evaluated using a combination of Sedimentation…
High-Throughput Preformulation Development Platform for Biologics
Summary: Typically, in early development, the quantity of protein available for studies is limited, and a dataset is required to expedite Tox- and IND-enabling stability studies. In this study, a high-throughput formulation development…
Rapid Global Characterization of Immunoglobulin G1 Following Oxidative Stress
Summary: While peroxide and leachable metal-induced chemical modifications are among the most important quality attributes in bioprocess development, there is no mainstream characterization method covering all common…
Analytical Quality by Design Using Design of Experiments
Summary: At the center of analytical Quality by Design (QbD) is Design of Experiment (DoE). Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method…
From Basics To Best Practices: Exploring Bioassays And Binding Assays
Summary: Biologics analytical testing is rapidly evolving as new testing protocols become available and companies seek to expedite current methodologies. Learn about the latest cell-based…
Biologics Brochure
Summary: Explore our suite of proprietary technology platforms and range of integrated development, manufacturing and clinical supply services. Catalent Biologics partners with leading biologic and…
Biologics Analytical Services Capabilities Sheet
Summary: Learn about Catalent’s range of stand-alone GMP & non-GMP analytical solutions for large molecules.
Biophysical Characterization of a Therapeutic mAb and its Associated Antigen-Binding Fragments
Summary: Changes during purification, formulation, fill-finish, and distribution can affect protein stability and practically all steps in the manufacturing process may perturb the higher-order structure and heterogeneity of the molecule…
Accelerated Development Through Strategic Analytical Partnerships
Summary: Learn about the new strategy model for outsourcing – When two or more parties begin with a candid, transparent, and well thought-out process to full…
A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
Summary: Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability…
New 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…
Advances 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.
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…
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…
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…
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…
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…