SPECIAL FEATURE – Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
IMAGE-BASED CHARACTERIZATION – Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Matt McGann explains how Microfluidic Modulation Spectroscopy is the final addition in the biophysical characterization scientist’s toolkit.
CHARACTERIZATION CORNER – From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.
Brent Lieffers, Senior Director of Operations, discusses the need for keeping up with trends and technology as an innovative CDMO.
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
EXCLUSIVE ONLINE CONTENT
Cytel Inc. recently announced that it has acquired MTEK Sciences to further expand its advanced real-world analytics (RWA) capabilities….
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
Saama Technologies, Inc. recently announced it has signed a definitive agreement to acquire Comprehend Systems, Inc. to create an exciting, enhanced suite of………..
MilliporeSigma has acquired BSSN Software, a Darmstadt, Germany-based laboratory informatics company that makes data more readily accessible for ease of integration, collaboration, analysis and…..
Cambrex Corporation recently announced it has signed a definitive agreement to be acquired by an affiliate of the Permira funds in a transaction valued at approximately……