Analytical Testing
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Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.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.
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
EXCLUSIVE ONLINE CONTENT
Ascendia Pharmaceuticals Secures Growth Equity Investment From Signet Healthcare Partners
Ascendia Pharmaceuticals, Inc. is a specialty CDMO dedicated to developing and manufacturing enhanced formulations for pre-clinical, clinical-stage drug candidates, and marketed drug products. The investment was made by Signet Healthcare Partners….
Cerba Research Announces Time-Saving COVID-19 Exploratory Tools & NGS Advancements
Cerba Research recently announced it has developed two new COVID-19 exploratory tools to enhance clinical research for the development of vaccines and treatments for COVID-19 and other infectious diseases…..
Stevanato Group Launches After-Sales Service Offering for Technologies & Manufacturing Equipment by Establishing a Global Network
Stevanato Group has launched an updated comprehensive, global after-sales service offering for pharmaceutical customers. Effective from January this year,….
Nexelis Acquires GSK Vaccines Clinical Bioanalytical Laboratory
Nexelis, a portfolio company of Ampersand Capital Partners, and a leading provider of advanced assay development and laboratory testing services in the infectious, oncologic, and metabolic diseases fields, has signed an asset purchase agreement with GSK to….
Hovione Launches the Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation
Hovione, the leader in Pharmaceutical Spray Drying, recently announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions…..