Analytical Testing
EXTRACTABLES & LEACHABLES - A Practical Approach to Extractables & Leachables
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
HUMAN MICROBIOME - Advancing New Frontiers in a Rapidly Emerging Market
Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.
EXECUTIVE INTERVIEW - Singota Solutions: Keeping Up With Trends & Technology as a CDMO
Brent Lieffers, Senior Director of Operations, discusses the need for keeping up with trends and technology as an innovative CDMO.
PREFILLED SYRINGES - Prefilled Syringe Automated Inspection & End-Product Testing
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
ORALLY INHALED PRODUCTS - Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
EXECUTIVE INTERVIEW - MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
EPR SPECTROSCOPY - Bringing EPR to a Wider World: Biological ROS & RNS Detection
Kalina Ranguelova, PhD, demonstrates how the latest digital and microwave technologies in benchtop EPR instrumentation is giving researchers new insight into ROS and free radicals that may shape the future development of more effective treatments of disease.
SCALE-UP & MANUFACTURING - Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact
Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.
SPECIAL FEATURE - Analytical Testing - Contractors Take on the Challenge of Complex Molecules
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
NEXT-GENERATION SEQUENCING - Emerging Clinical Applications & Projections to 2022
Laurie L. Sullivan and John Bergin, MS, MBA, say the growth curve for clinical applications of NGS is approaching an upward trajectory as existing applications gain traction and new ones begin to establish a foothold.
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…