Analytical Testing
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.
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.
EXCLUSIVE ONLINE CONTENT
Aptar Acquires Nanopharm & Gateway Analytical
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 Completes New Process & Analytical Development Facility
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 Appoints Biologics Manager at Expanded Life Sciences Facility in Illinois
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 Expands Analytical Capabilities
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 Announces a New Paradigm in DNA Sequencing
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).