Analytical assays ensure that biosimilar CQAs are on track.

The Right Assay at the Right Time

Preventing carcinogenic compounds from the pharma supply chain requires coordination.

Detecting Dangerous APIs

Topic

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Articles

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

Sai Life Sciences’ Screening Capabilities Enhanced with Expanded Cellular Analysis Platforms

The new personal capillary electrophoresis system, Spectrum Compact CE, performs Sanger sequencing and fragment analysis.

Promega’s New Capillary Electrophoresis Instrument Enhances Benchtop Analysis

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

Aigenpulse’s Data Analysis Suite Automates Flow Cytometry

Brian W. Pack is senior research advisor with Eli Lilly and Company in Indianapolis, IN.

Dawn E. Sailer is associate quality advisor with Eli Lilly and Company, Indianapolis, IN.

Mark D. Argentine is senior research advisor with Eli Lilly and Company, Indianapolis, IN.

Amy R. Barker, barker_amy_r@lilly.com, is senior quality advisor with Eli Lilly and Company, Indianapolis, IN.

Method-transfer kits help simplify analytical method transfer for global site certifications.

Streamlining Method Transfer Across Global Sites

Lucelys Caton is a technical service scientist with Gaylord Chemical Company.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient. 

Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEur

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

Thermo Fisher and CROs Expand Access to Cryo-EM

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology 

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Using Analytical Assays to Ensure Biosimilar Quality

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

Analytics

The Right Assay at the Right Time

Detecting Dangerous APIs