Analytical Testing
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
CHARACTERIZATION CORNER – A New Weapon in Formulation Development
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.
SPECIAL FEATURE – Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
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.
EXTRACTABLES & LEACHABLES – A Practical Approach to Extractables & Leachables
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.
HUMAN MICROBIOME – Advancing New Frontiers in a Rapidly Emerging Market
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.
EXECUTIVE INTERVIEW – Singota Solutions: Keeping Up With Trends & Technology as a CDMO
Brent Lieffers, Senior Director of Operations, discusses the need for keeping up with trends and technology as an innovative CDMO.
PREFILLED SYRINGES – Prefilled Syringe Automated Inspection & End-Product Testing
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.
EXCLUSIVE ONLINE CONTENT
Fusion Antibodies Partners With Eurofins Discovery to Support Innovative Preclinical Drug Discovery Research
Fusion Antibodies plc recently announced it has entered into a commercial collaboration with Eurofins, a Eurofins Scientific SE (EUFI.PA) group company; a leading provider of products and services to the….
Pace Life Sciences Acquires Drug Delivery Experts, Expanding Capacity & Injectable Drug Product Services
Pace Analytical Life Sciences, LLC, a subsidiary of Pace Analytical Services, LLC, a full-service contract development and manufacturing organization (CDMO), recently announced it has acquired Drug Delivery Experts, LLC (DDE)…..
Microfluidics: An Alternative Method for Developing Nanoparticle Drug Delivery Systems
The encapsulation of drugs within purposely formulated liposome nanoparticles offers the potential for more controlled and sustained release, as well as reducing toxicity and….
Ascendia Pharmaceuticals Secures Growth Equity Investment From Signet Healthcare Partners
Ascendia Pharmaceuticals, Inc. is a specialty CDMO dedicated to developing and manufacturing enhanced formulations for pre-clinical, clinical-stage drug candidates, and marketed drug products. The investment was made by Signet Healthcare Partners….
Cerba Research Announces Time-Saving COVID-19 Exploratory Tools & NGS Advancements
Cerba Research recently announced it has developed two new COVID-19 exploratory tools to enhance clinical research for the development of vaccines and treatments for COVID-19 and other infectious diseases…..