Analytical Testing
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.
BIOANALYTICS TECHNOLOGY - New Bioanalytical Technology Holds Promise for Alzheimer's Research
Stephen Turner believes a next-generation capability is now available to rapidly and comprehensively provide molecular profiles of normal and AD-affected brain cells and tissues, offering the possibility of new, AD stage-specific biomarkers and points of therapeutic intervention for developing new treatments.
EXECUTIVE INTERVIEW - Presage Biosciences: Comparing Multiple Drugs & Combinations Directly in a Patient’s Tumor
Nathan Caffo, President of Presage Biosciences, discusses his company’s technology with the potential to usher in a new era of cancer drug development and testing.
PARTICLE AGGREGATION ANALYSIS - Biologics & Particulates: Identification & Control in the Product Lifecycle
Zabin Younes says that traditional tools, such as SEC and DSC, have been used in formulation screening; however, to ensure a control of particulate counts, it is important to use the full range of tools to ensure all types and sizes of particles and aggregates are assessed and accounted.
DYNAMIC LIGHT SCATTERING - Colloidal Gold: The Gold Standard for Drug Delivery?
Stephen Ball explores the importance of particle size in biomedical nanotechnology. Experimental data are presented to illustrate how advanced DLS techniques deliver these measurements for colloidal gold in the nanosized and sub-nanosized ranges.
SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development
Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.
EXECUTIVE INTERVIEW - Avomeen: A Unique Approach to the Traditional Analytical CRO
Shri Thanedar, PhD, CEO & Chief Chemist at Avomeen Analytical Services, discusses what sets his company’s analytical laboratory apart from other CROs that serve the pharmaceutical industry.
LAB DEVELOPED TESTS - FDA Working on LDT Guideline: Implications & Questions
Aish Vivekanandan, Industry Analyst at Frost & Sullivan, reports that in the past several years, it seemed that a cry for regulation of LDTs was falling on deaf years at the FDA. However, after a thorough and intricate letter from the Senate and public outcry for regulations, it seems the FDA is finally taking action.
IMMUNOCHEMISTRY ANALYZER MARKET - Mutiplexing Technologies for Infectious Disease, Cancer, Cardiac & Autoimmune Testing Rise Above the Horizon
Divyaa Ravishankar, MS, Senior Industry Analyst at Frost & Sullivan, indicates the market has undergone a massive change from just a few vendors offering only enzyme-linked immunosorbent assay, chemiluminescent immunoassay, radioactive immunoassay, and flourescent immunoassay to also multiplex assays, such as microarrays, flow cytometry-based platforms, recombinant immunoassays, and indirect immunofluorescence assays.
EXCLUSIVE ONLINE CONTENT
Bio-Rad Launches Vericheck ddPCR Replication Competent Lentivirus & Replication Competent AAV Kits for Cell & Gene Therapy Production
Bio-Rad Laboratories, Inc. recently announced the launch of the Vericheck ddPCR Replication Competent Lentivirus Kit and the Vericheck ddPCR Replication Competent AAV Kit. The kits provide rapid….
Abzena Launches LabZient™, an Analytical Platform to Expedite the Path to IND for Antibodies
Abzena recently announced the launch of its new analytical platform, LabZient™. The standardized and automated platform streamlines the assessment and validation of large molecules, which significantly….
Novo Holdings to Acquire Catalent
Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, recently announced they….
Bio-Rad Extends Range of Anti-Idiotypic Antibodies for Use in Preclinical & Clinical Drug Development
Range of highly selective anti-idiotypic antibodies now includes six antibodies specific to dupilumab and its biosimilars for bioanalysis and drug monitoring….
Woodstock Sterile Solutions Completes Analytical Lab Expansion, Becomes One-Stop Shop CDMO
Woodstock Sterile Solutions has recently completed an expansion of its quality control analytical laboratory at its production facility in Woodstock, IL. The larger laboratory accommodates…
MARKET NEWS & TRENDS
WEBINARS
WEBINAR: BPOG 2020 & USP 665 – Extractables Testing of Single-Use Systems
This webinar will explore how to conduct effective extractables and leachables (E&L) testing on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing…..
WHITE PAPERS
WHITEPAPER - How to Mitigate Risk for Biologics During Fill/Finish Manufacturing
Aseptic processing with the highest degree of sterility assurance, filling accuracy, and quality is critical for high-value, small-batch therapies. This white paper explores the specialized…
WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….
eBOOK: Antibody Production
Antibody production is a multi-step complex process and generating reproducible antibodies is highly critical for immunoassays-based research, immunodiagnostics, and immunotherapy. Antibodies’ reproducibility is driven by…