Analytical Testing
PARTICLE AGGREGATION ANALYSIS – Biologics & Particulates: Identification & Control in the Product Lifecycle
Zabin Younes says that traditional tools, such as SEC and DSC, have been used in formulation screening; however, to ensure a control of particulate counts, it is important to use the full range of tools to ensure all types and sizes of particles and aggregates are assessed and accounted.
DYNAMIC LIGHT SCATTERING – Colloidal Gold: The Gold Standard for Drug Delivery?
Stephen Ball explores the importance of particle size in biomedical nanotechnology. Experimental data are presented to illustrate how advanced DLS techniques deliver these measurements for colloidal gold in the nanosized and sub-nanosized ranges.
SPECIAL FEATURE – Analytical Testing: A Critical Element in Drug Development
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.
EXECUTIVE INTERVIEW – Avomeen: A Unique Approach to the Traditional Analytical CRO
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.
LAB DEVELOPED TESTS – FDA Working on LDT Guideline: Implications & Questions
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.
IVD TRENDS – In Vitro Diagnostics Players Go Global as US & Europe Markets Slow Down
Despite economic and industry challenges, the global in vitro diagnostics (IVD) market is growing robustly – at double the rate of the global pharmaceutical industry…
EXECUTIVE INTERVIEW – SGS Life Science Services: Getting Medicines to Market Quickly & Safely
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.
LEACHABLES STUDIES – Investigating Leachables in Oral Solid Dosage Forms
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.
EXCLUSIVE ONLINE CONTENT
Cytel Acquires MTEK Sciences, Further Expanding Advanced Real-World Analytics Capabilities
Cytel Inc. recently announced that it has acquired MTEK Sciences to further expand its advanced real-world analytics (RWA) capabilities….
Analytical Testing in Drug Development eBook – Regulations Help Propel Testing Market
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 & Comprehend to Form Preeminent Clinical Analytics Platform Company
Saama Technologies, Inc. recently announced it has signed a definitive agreement to acquire Comprehend Systems, Inc. to create an exciting, enhanced suite of………..
MilliporeSigma Acquires BSSN Software to Accelerate Customers’ Digital Transformation in the Lab
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 to be Acquired by the Permira Funds
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……