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.
ORALLY INHALED PRODUCTS – Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
EXECUTIVE INTERVIEW – MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
EXCLUSIVE ONLINE CONTENT
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….
FREEZE-DRYING MICROSCOPY – Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
Proveris Expands Product Portfolio With New Kinaero Cx pMDI Collection System for Delivered Dose Uniformity & Aerodynamic Particle Size Distribution Testing
Proveris Scientific Corporation recently introduced the Kinaero Cx pMDI Collection System to automate the pMDI shaking, priming, dose sample collection, and fire-down for….
Malvern Panalytical Expands Pharmaceutical Drug Development Solutions Through Acquisition of Creoptix
Malvern Panalytical recently announced its acquisition of Creoptix AG, a specialist bioanalysis sensor company. The acquisition forms a critical part of Malvern Panalytical’s strategy to….
Inotiv, Inc. & Synexa Life Sciences Sign Letter of Intent to Establish Center of Excellence for Biotherapeutics & Biomarkers
Inotiv, Inc. and Synexa Life Sciences recently announced they intend to form a collaboration that will accelerate Inotiv’s development of biomarkers essential to the understanding of safety and efficacy of novel biotherapeutics, enhancing the….
MARKET NEWS & TRENDS
This webinar will explore how to conduct effective extractables and leachables (E&L) testing on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing…..
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….
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…