Analytical Testing
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.
ASSAY VALIDATION - Biomarker Assay Validations – A Time for Change?
John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.
SAMPLE PREPARATION MARKETS - Automation & Application Trends Drive Growth in Sample Preparation Markets
Christi Bird indicates sample preparation remains a critical task in many research and testing workflows across biopharmaceutical, basic research, clinical, and industrial applications. While the market lacks the hype and excitement of NGS, CRISPR/Cas9, or the microRNA and epigenetics boom several years ago, the sample preparation market will always be a slow and steady gainer on an already large market size.
AAV VECTOR MANUFACTURING - Challenges & Opportunities in the Manufacturing of AAV Vectors Used in the Delivery of Gene Therapy Treatments
Daniel C. Smith, PhD, indicates there remains a clear need for improved process productivities, and the need to develop manufacturing processes that can be applied to a wide number of AAV-based viral vector therapeutic candidates.
BIOMARKERS - FDA’s Design Control Requirements for Biomarkers in Drug Development
Kaiser J. Aziz, PhD, says the availability of validated biomarker-drug companion products will enable the molecular diagnostics and pharmaceutical industries to develop and rely on new genomic biomarkers in order to elucidate disease pathways, stratify patient populations, and monitor safe and effective use of these products.
SPECIAL FEATURE - Analytical Testing: Market Drivers, Growing Demand & Client Needs
Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.
DNA SEQUENCING MARKET - Emerging Technologies & Applications
Laurie L. Sullivan and John Bergin, MS, MBA, BCC Research Analysts, indicate that NGS has matured into an essential life science tool for genetic studies in a range of applications, and the industry is on the cusp of a second growth phase, powered by new applications in clinical diagnostics.
PARTICULATE IDENTIFICATION - Particle Identification for Improvement of Pharmaceutical Production
Kathryn A. Lee, PhD; Markus Lankers, PhD; and Oliver Valet, PhD, discuss various aspects with regard to microscopic particle counting, sizing, and identification using Raman, laser-induced breakdown, and IR spectroscopies, and how these techniques can help accurately identify particles.
PHARMACOLOGY MODELS - Early Phase Pharmacodynamic Models for Respiratory Drug Candidates
Robert Lins, MD, PhD, believes classical primary respiratory endpoints are far from successful in exploratory and confirmatory studies, and new techniques being developed have most potential in early phase, exploratory, clinical trials, but there may be the opportunity to apply at least some of them in the later stages of development.
NANOPARTICLE CHARACTERIZATION - One Size Does Not Fit All: Nanoparticle Size Analysis for Nanomedicine Applications
Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.
MRI CONTRAST AGENTS - Could More Stable Soon Also Mean Safer?
Frost & Sullivan Analyst Nadim Michel Daher indicates radiology is going through interesting times. Under the coordinated care paradigm that is gradually emerging in the US, as well as all the changes forced on volume-based economic models, medical imaging enterprises are under a great deal of pressure to redefine their goals and reassess their value.
DRUG DEVELOPMENT - Don't Overlook Key Preclinical Research
Robert Wenslow, PhD, and Ann Newman, PhD, believe too often, drug discovery scientists, material scientists, and formulation specialists work in silos throughout the drug discovery process. Better integration of their efforts can reduce drug development schedules, risk, and overall costs that provide direct competitive business advantages.
DISSOLUTION TESTING - Exploring the Link Between Particle Size & Dissolution Behavior for OINDPs
Paul Kippax, PhD; Deborah Huck-Jones, PhD; et al review current trends in dissolution testing within the context of understanding particle size, which impacts clinical studies and ultimately generic submissions.
NEXT-GENERATION SEQUENCING - NGS: Uniformity Across the Block
Andrew Birnie, PhD, explores how innovations in instruments, such as the Eco 48 real-time qPCR system (PCRmax), deliver exceptional uniformity, actively improving the reliability and productivity of the working laboratory.
CLOUD COMPUTING - Using Quantum Molecular Design & Cloud Computing to Improve the Accuracy & Success Probability of Drug Discovery
Ed Addison and Shahar Keinan, PhD, explain how cloud computing combined with the continued influence of Moore’s Law has provided an unprecedented opportunity to apply inexpensive high-performance computing to drug discovery.
SPECIAL FEATURE - Analytical Testing: Using More Sophisticated Tools to Support Small & Large Molecule Projects
Contributor Cindy H. Dubin recently spoke with leading analytical testing providers to find out what services they offer and what equipment they use to handle both small and large molecules for their pharma clients.
IMMUNOASSAY PLATFORM - Accelerating Drug Development & Clinical Validation With Single Molecule Counting
Steven Suchyta, PhD, discusses how Ultrasensitive Single Molecule Counting technology provides an indispensable tool in the researcher’s arsenal to help move novel biology forward, fueling the discovery and development of new therapeutics.
DIAGNOSTIC TESTING - Diabetes Diagnostic Testing: A Move From Invasive to Non-Invasive Testing
Divyaa Ravishankar, Frost & Sullivan Analyst, focuses on the innovations around self-monitoring glucose meters and continuous glucose monitoring devices, providing in-depth competitive intelligence on some of the technologies and non-invasive techniques.
CELL CULTURE MARKET - 3D Cell Cultures: Next Generation & New Challenges
Kevin James and Robert G. Hunter of BCC Research say significant growth within the biopharmaceuticals industry is spurring unprecedented innovation in and demand for cell culture products for the purposes of drug discovery and safety testing. While 2D cell cultures have been in laboratory use since the 1950s, the market for 3D cultures has witnessed spectacular growth throughout the past decade.
LOC-BASED DEVICES - Lab on Chip – How Far Are We Along the Road?
Divyaa Ravishankar, MS, indicates LOC-based devices are an integration of multiple disciplines and the miniaturization of the major laboratory procedures. Recently, these devices are branching into additional aspects of healthcare, such as drug delivery, stem cell, environmental monitoring, and synthetic biology.
Frequently Asked Questions About Analytical Testing
What are the latest trends in analytical testing for pharmaceuticals?
How are CDMOs improving resilience in analytical supply chains?
What role does automation play in modern analytical labs?
