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.
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.
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.
Kalina Ranguelova, PhD, demonstrates how the latest digital and microwave technologies in benchtop EPR instrumentation is giving researchers new insight into ROS and free radicals that may shape the future development of more effective treatments of disease.
SCALE-UP & MANUFACTURING – Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact
Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.
EXCLUSIVE ONLINE CONTENT
AptarGroup, Inc. recently announced it has acquired two leading pharmaceutical services companies, Nanopharm Ltd. and Gateway Analytical LLC, for a combined enterprise value of approximately $50 million.
Cambrex Corporation recently announced it has completed a new facility at its site in Karlskoga, Sweden, which incorporates new laboratories for process and analytical development.
SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, today announced the appointment of Dr. Haris Jamil as Biologics Manager of its recently expanded biopharmaceutical testing facility in Lincolnshire, Illinois, USA.
Cambrex Corporation recently announced it is investing $1 million at its High Point, NC, site to fit out 1,300 sq ft of analytical laboratory space and plans to hire 9 chemical research and development scientists, as well as 6 analytical research and development scientists pursuant to this project.
Pacific Biosciences of California, Inc. recently announced major enhancements to its Sequel System, including a new version (6.0) of its software, new consumable reagents (3.0) and a new SMRT Cell (1M v3).