Analytical Testing
DEVICE DEVELOPMENT – Designing Devices for Inhaled Drugs
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
IMMUNOGENICITY TESTING – Regulatory Updates for Immunogenicity Assessment of Therapeutic Proteins
Leon Shi, PhD, Lan Li, MS, and Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.
2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development
This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.
DRUG DISCOVERY – Disrupting Drug Discovery From Assay Development to Lead Compound
Zack Gurard-Levin, PhD, says with new innovations in assay methodologies, scientists no longer have to make sacrifices to do quality drug discovery research.
SPECIAL FEATURE – Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
IMAGE-BASED CHARACTERIZATION – Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
CHARACTERIZATION CORNER – A New Weapon in Formulation Development
Matt McGann explains how Microfluidic Modulation Spectroscopy is the final addition in the biophysical characterization scientist’s toolkit.
CHARACTERIZATION CORNER – From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
SPECIAL FEATURE – Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
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…