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.
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.
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.
Despite economic and industry challenges, the global in vitro diagnostics (IVD) market is growing robustly – at double the rate of the global pharmaceutical industry…
Drug Development Executive: Mark Rogers, PhD, Senior Vice President Life Science Services at SGS, talks about his company’s evolutionary development and the trends it is witnessing in the analytical testing market.
Chris Connolly and Niculae Miron indicate that with increasingly potent drug products and lower acceptable levels of contaminants today, more-sensitive analytical methods must be used to detect and analyze leachables and determine drug product safety.
ADAPTIVE FOCUSED ACOUSTICS – Scalability of AFA in Nanoemulsions: From Microliters to Continuous Flow
Laura E. Forte and Srikanth Kakumanu, PhD, conduct a study demonstrating that Covaris’ AFA can quickly and easily produce nanoemulsions on sample scales varying from 300 microliters to continuous flow.
DISPOSABLE TECHNOLOGY – Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations
Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?
Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.
EXCLUSIVE ONLINE CONTENT
Cytel Inc. recently announced that it has acquired MTEK Sciences to further expand its advanced real-world analytics (RWA) capabilities….
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
Saama Technologies, Inc. recently announced it has signed a definitive agreement to acquire Comprehend Systems, Inc. to create an exciting, enhanced suite of………..
MilliporeSigma has acquired BSSN Software, a Darmstadt, Germany-based laboratory informatics company that makes data more readily accessible for ease of integration, collaboration, analysis and…..
Cambrex Corporation recently announced it has signed a definitive agreement to be acquired by an affiliate of the Permira funds in a transaction valued at approximately……