Analytical Testing
EXTRACTABLES & LEACHABLES - Detecting the Unknown With Extractables & Leachables Analysis
Derek Wood, Xiaochun Yu, PhD, and Aaron Lamb review how a new generation of extraction, identification, and quantification tools, now recognized as approved methods by regulatory bodies, are changing the E&L testing landscape.
SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
ROUNDTABLE DISCUSSION - Which Trends Will Have the Most Impact on Drug Development in 2023?
Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.
2023 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
MEDICAL DEVICE TESTING - Chemical Characterization & the Non-Targeted Analysis of Medical Devices
Luminita Moraru, MSC, MRSC, says the medical devices industry is in continuous growth, and the development of new reliable and accurate approaches in order to assess the safety of the products should constantly be reviewed.
2022 Analytical Testing eBook – Service Providers Offer Innovation
Learn more about the technologies from Alcami, Associates of Cape Cod, Stevanato Group, and West in this exclusive 2022 Drug Development & Delivery Analytical Testing e-book.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
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….
AUTOMATION SOLUTIONS - The Future of Lab Tech Will Combine Automation, Accuracy & Agility
Rich Ellson and John Fuller, PhD, say accelerating development comes down to designing and using flexible automation solutions along with smarter instruments and new consumable paradigms to help meet researchers’ needs.
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…..
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…