Analytical Testing
DIGITAL CUSTOM PLATFORM – PCI Pharma’s Digital Transformation: Reaching New Levels of Customer Experience
Wayne Hull and Rebecca Coutts, PhD, explain how incorporating digital transformation as core to their company’s business strategy was a decision based on increasing evidence that investment in digital solutions provides real and measurable returns.
SPECIAL FEATURE – Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.
2021 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
ASSAY DEVELOPMENT – Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma
Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.
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Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.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.
EXCLUSIVE ONLINE CONTENT
Copley Launches New Semi-Automation Tool for Inhaled Product Testing
Copley Scientific, the global leader in inhaled product testing equipment, has launched the new Gentle Rocker 100i, a simple, cost-effective device that boosts the productivity and repeatability of….
FREEZE-DRYING MICROSCOPY – Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
Proveris Expands Product Portfolio With New Kinaero Cx pMDI Collection System for Delivered Dose Uniformity & Aerodynamic Particle Size Distribution Testing
Proveris Scientific Corporation recently introduced the Kinaero Cx pMDI Collection System to automate the pMDI shaking, priming, dose sample collection, and fire-down for….
Malvern Panalytical Expands Pharmaceutical Drug Development Solutions Through Acquisition of Creoptix
Malvern Panalytical recently announced its acquisition of Creoptix AG, a specialist bioanalysis sensor company. The acquisition forms a critical part of Malvern Panalytical’s strategy to….
Inotiv, Inc. & Synexa Life Sciences Sign Letter of Intent to Establish Center of Excellence for Biotherapeutics & Biomarkers
Inotiv, Inc. and Synexa Life Sciences recently announced they intend to form a collaboration that will accelerate Inotiv’s development of biomarkers essential to the understanding of safety and efficacy of novel biotherapeutics, enhancing the….
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
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…