Biopharmaceutical Analysis

Editor of Pharmaceutical Technology Europe

Articles

As the therapeutic landscape grows more complex, so too must the analytical techniques for cleaning validation to ensure the utmost cleanliness is achieved.

Cleaning Up in Bio/Pharma

Ryan Burke is the environmental monitoring manager for Element Materials Technology.

Madison Prifti is the senior environmental monitoring analyst for Element Materials Technology.

Effective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.

Cleanroom Cleaning: Proper Methodology and Determining Efficacy

Scientists can work to overcome the challenges associated with protein characterization through empowering technologies.

Empowering Protein Characterization

David Smith, PhD, is the vice president of technical operations for Ori Biotech.

Courtney LeBlon, PhD, is the director of technical operations for Ori Biotech.

Stephen Shapka, PhD, is the lead automation engineer for Ori Biotech.

Redefining Contamination Control for CGTs

Feliza Mirasol is the science editor for 

Establishing a data management strategy in-lab is a first step in generating successful analytical studies.

Increased Data Flow Demands Strategic Management

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

Bioanalytical Studies Support Biosimilars Approval Pathway

Joana S. Cristóvão, PhD, jscristovao@hovione.com, is an analytical scientist at Hovione Farmaciência S.A., R&D, Analytical Development.

Salomé Neto was a Master’s student at Hovione Farmaciência S.A., R&D, Analytical Development.

Establishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.

Conformational and Colloidal Stability Studies to Predict the Best Biopharmaceutical Formulation

Thomas A. Little, PhD, is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.

Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria

Stuart Pengelley is the senior scientist, Biopharma Application Development for Bruker Daltonics.

Sophisticated analytical technologies are complementing traditional approaches in the identification of residual process-related impurities of biotherapeutics.

Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS

Mark Rogers, PhD, mark.rogers@sgs.com, is the global scientific director for the SGS Health Science Drug Development group. He  has been with SGS for nearly 8 years since joining the company via an acquisition (M-Scan) in 2010. Rogers received his PhD in analytical chemistry from Westminster University in 1985 and has over 35 peer-reviewed publications, including Nature, and one patent. His post-doctoral work, at Imperial College, London, was followed by a lectureship in the endocrinology department at St. Mary’s hospital specializing in diabetes. Rogers then went on to join M-Scan, USA in 1990 where he remained as vice-president until its acquisition by SGS. Since joining SGS he has had several roles including, head of North American Biologics, vice-president of SGS USA, and today, he is the Global Scientific director for the SGS Health Science Drug Development group.

New challenges in extractable and leachable studies for cell and gene therapy products.

Analytical Best Practices