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
Cytel Acquires MTEK Sciences, Further Expanding Advanced Real-World Analytics Capabilities
Cytel Inc. recently announced that it has acquired MTEK Sciences to further expand its advanced real-world analytics (RWA) capabilities….
Analytical Testing in Drug Development eBook – Regulations Help Propel Testing Market
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 & Comprehend to Form Preeminent Clinical Analytics Platform Company
Saama Technologies, Inc. recently announced it has signed a definitive agreement to acquire Comprehend Systems, Inc. to create an exciting, enhanced suite of………..
MilliporeSigma Acquires BSSN Software to Accelerate Customers’ Digital Transformation in the Lab
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 to be Acquired by the Permira Funds
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……