Biopharmaceutical Analysis

Articles

Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.

Thermo Fisher Expands Hematology Oncology NGS Portfolio

Feliza Mirasol is the science editor for 

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

Complex Biomolecules Require Analytical Evolution

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

Olaf Stamm, PhD, is scientific advisor, biologics testing with Charles River.

Andrew Hanneman, PhD, is scientific advisor, biologics testing with Charles River.

Art Cansizoglu, PhD, is senior scientist with Charles River.

Thorsten Strahl is supervisor protein and scientific officer with Charles River.

Gene therapy products present a unique set of challenges for the control of host cell protein impurities.

Detecting Residual HCPs Demands a Holistic Approach

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

Holly Lombardo, HLombardo@redshiftbio.com, is product manager at RedShiftBio.

Matthew McGann is marketing manager at RedShiftBio.

Microfluidic Modulation Spectroscopy is a recent innovation in infrared spectroscopy techniques that improves elucidation of secondary protein structure.

Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

Thermo Fisher Expands Gene Therapy Portfolio to Support AAV Manufacturing

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

Viral Clearance Testing Increasingly Challenged by New Biologic Modalities

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.

Preparing for the Unexpected: E&L Studies in Biopharma

Chalmers University researchers have developed a method to label and track mRNA molecules.

Analytical Methods