Analytical Testing
ADAPTIVE FOCUSED ACOUSTICS – Scalability of AFA in Nanoemulsions: From Microliters to Continuous Flow
Laura E. Forte and Srikanth Kakumanu, PhD, conduct a study demonstrating that Covaris’ AFA can quickly and easily produce nanoemulsions on sample scales varying from 300 microliters to continuous flow.
DISPOSABLE TECHNOLOGY – Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations
Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?
SPECIAL FEATURE- Analytical Testing of Biologics & Biosimilars
Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.
RESIDUAL IMPURITIES – Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment
Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.
MASS SPECTROMETRY – Access for All – A New Solution to the Age Old Challenge of a Multi-Vendor Open Access Laboratory
Hayley Crowe reviews AxION(R) eDoor(TM), a web-based, multi-vendor, open-access software platform that addresses all the complexities associated with analytical mass spectrometry analysis.
PREDICTIVE MODELING – Predicting Price Changes of Oncology Drugs in the US: Can Proportional Hazard Models Predict the Timing & Percentage of Changes?
Bruce Wang, PhD, MA, suggests that Cox Proportional Hazard Models can be used to predict price change percentages and timing of prescription drugs in the market, which is extremely valuable as it enables more informed insights through predictive modeling and analytics on the lifecycle of a drug.
LIPOSOME PREPARATION TECHNOLOGY – Freeze Fracture Electron Microscopic (ff EM) Examination & Analysis of Liposomes Produced by Covaris AFA Technology
Srikanth Kakumanu, PhD, and Rajeev A. Jain, PhD, explain how an alternative ultrasonic processing technology allows manufacturing of liposomes of predetermined sizes and offers an efficient, isothermal, and non-contact process.
AUTOLOGOUS CELL THERAPIES – Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success
Ronnda L. Bartel, PhD, Tod Borton, and Brian S. Hampson review how Aastrom Biosciences has developed the innovative processes necessary to reduce risk throughout the manufacturing process. The company is now preparing for future commercialization for its investigational therapy derived from a patient’s own bone marrow stem cells.
IMPURITIES DETECTION – Impurities Detection in Pharmaceuticals
Kevin P. Menard, PhD, focuses on the detection of residual solvents from processing and small levels of contaminates leached from containers.
SPECIAL FEATURE – Analytical Instrumentation Gets Faster, Smaller, and Easier to Use
Contributor Cindy H. Dubin learns that one doesn’t have to be a rocket scientist to use analytical instrumentation. Three leading players in the market showcase their products, all aimed at making analysis easier and faster.
EXCLUSIVE ONLINE CONTENT
Spectradyne Launches New ARC Particle Analyzer
Spectradyne recently launched its second-generation product, the ARC particle analyzer. Spectradyne’s ARC is a ground-breaking technology for analyzing biological nanoparticles in complex….
BD Launches State-of-the-Art Cloud Software Solution to Streamline Flow Cytometry Research
BD (Becton, Dickinson and Company) recently launched BD® Research Cloud, a cloud-based software solution designed to streamline the flow cytometry workflow to enable higher….
RQM+ Acquires Jordi Labs
RQM+ recently announced the acquisition of Jordi Labs. With these new capabilities, RQM+ provides comprehensive regulatory, quality, clinical, and laboratory services, supporting market….
US Alliance Pharma Acquires UK-Based LGC’s Drug Development Solutions Business
Alliance Pharma recently closed on the purchase of Drug Development Solutions (DDS) from LGC. Ampersand Capital Partners, a global healthcare private equity firm, and KKR & Co. Inc., a leading global investment….
Copley Launches New Semi-Automation Tool for Inhaled Product Testing
Copley Scientific, the global leader in inhaled product testing equipment, has launched the new Gentle Rocker 100i, a simple, cost-effective device that boosts the productivity and repeatability of….
MARKET NEWS & TRENDS
WEBINARS
WEBINAR: BPOG 2020 & USP 665 – Extractables Testing of Single-Use Systems
This webinar will explore how to conduct effective extractables and leachables (E&L) testing on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing…..
WHITE PAPERS
WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….
eBOOK: Antibody Production
Antibody production is a multi-step complex process and generating reproducible antibodies is highly critical for immunoassays-based research, immunodiagnostics, and immunotherapy. Antibodies’ reproducibility is driven by…