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.
ANALYTICAL TESTING – Improvements in Characterization of Pharmaceuticals: Fast Scanning Rate DSC Methods
Kevin P. Menard, PhD, MBA, says fast scanning rate DSC represents a recent and underutilized technique for the characterization of pharmaceutical materials and highlights several of the more common applications.
ANALYTICAL TESTING – Analytical Tools & Techniques in Hot Melt Extrusion & Case Studies on Formulation Development & Process Scale-Up
Tony Listro, MS, MBA; Mike Borek, Michael Crowley, PhD, MBA; and Kathrin Nollenberger, PhD; review how a stepwise approach to characterizing formulation prototypes using microscopy, thermal analysis, spectroscopy, nonsink dissolution testing, and chromatography can be used to rapidly rank order formulations.
ANALYTICAL TESTING – Diffusion Kinetics & Permeation Concentration of Human SC Characterization by Terahertz Scanning Reflectometry
Anis Rahman, PhD; Scott Frenchek; Brian Kilfoyle; Leena Patterkine, PhD; Aunik Rahman; and Bozena Michniak- Kohn, PhD; use terahertz reflectometry and spectrometry to investigate the permeation kinetics and concentration profile of active ingredients into the stratum corneum.
FORMULATION DEVELOPMENT – Particle Sizing Across the Drug Development Cycle
Carl Levoguer, PhD, examines how laser diffraction technology has been fashioned to powerfully support every stage of the drug development cycle.
SPECIAL FEATURE – Analytical Instruments: Global Demands, Innovations & Cost-Savings
Contributor Cindy H. Dubin recently spoke with some of the leading companies that offer analytical instrument equipment and services to find out how they are addressing pharma’s needs for faster (and more cost-efficient) testing.
EXCLUSIVE ONLINE CONTENT
Woodstock Sterile Solutions Completes Analytical Lab Expansion, Becomes One-Stop Shop CDMO
Woodstock Sterile Solutions has recently completed an expansion of its quality control analytical laboratory at its production facility in Woodstock, IL. The larger laboratory accommodates…
Nemera & Nelson Labs Europe Strengthen Partnership to Offer Integrated Services to Customers
This strategic alliance will give a unique advantage to pharmaceutical & bio-tech customers – accelerating the go-to-market of their drug-device combination products by offering analytical chemistry, drug compatibility lab testing and expert advice….
Biognosys & Bruker Form Partnership for Advanced Proteomics CRO Services for Global Biopharma & Biomarker Customers
New strategic partnership aims to broaden access to Biognosys’ leading CRO services and Spectronaut® software tools for unbiased proteomics and epiproteomics….
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….
MARKET NEWS & TRENDS
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…..
WHITEPAPER – How to Mitigate Risk for Biologics During Fill/Finish Manufacturing
Aseptic processing with the highest degree of sterility assurance, filling accuracy, and quality is critical for high-value, small-batch therapies. This white paper explores the specialized…
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…