Analytical Testing
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.
EPR SPECTROSCOPY – Bringing EPR to a Wider World: Biological ROS & RNS Detection
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.
SPECIAL FEATURE – Analytical Testing – Contractors Take on the Challenge of Complex Molecules
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
NEXT-GENERATION SEQUENCING – Emerging Clinical Applications & Projections to 2022
Laurie L. Sullivan and John Bergin, MS, MBA, say the growth curve for clinical applications of NGS is approaching an upward trajectory as existing applications gain traction and new ones begin to establish a foothold.
CENTRALIZED BIOMETRICS – The Backbone of a Global Clinical Data Strategy
Paul Fardy details the steps needed to implement a successful global clinical data strategy and how to approach developing a centralized process that results in transparency, traceability, accuracy, and collaboration.
ONCOLOGY DIAGNOSTICS – Advancements Paving the Way for More Tailored Drugs
Divyaa Ravishankar, MS, says pharmaceutical companies have been subjected to a wide variety of external forces compelling them to get innovative about development of new platforms, liaise with new partners, leverage big data toward precision and predictive diagnosis, and identify new markers.
MDI CHARACTERIZATION – Closing the Gap Between In Vitro Test Data & the In-Use Performance for Metered Dose Inhalers
David A. Lewis, PhD, presents experimental data that shows how certain modifications to the Pharmacopoeial test methods used for MDIs may result in data that is more indicative of real-life performance, providing insight that can be used to enhance drug delivery characteristics.
EXCLUSIVE ONLINE CONTENT
Thermo Fisher Scientific & CSL Enter Strategic Partnership to Provide Best-in-Class Pharma Services
Thermo Fisher Scientific Inc. and CSL Limited recently announced they have entered into a strategic partnership to help meet the growing demand for biologic therapies while also….
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…..