There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Articles

Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

Week Of April 5, 2010: Company And People Notes: Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

The Agilent 2100 Bioanalyzer plus the Agilent High Sensitivity Protein 250 Kit automatically detects and quantifies protein impurities down to 0.05% ? meeting ICH guideline Q3B(R2)!

Comply with ICH guidelines on impurities in new drug products

Hsiang Yu Hsieh is a graduate student at National Central University, 300 Jhong-Da Rd., Jhong-Li City 320, Taiwan, ROC.

Yan Chan Su is a graduate student at National Central University, 300 Jhong-Da Rd., Jhong-Li City 320, Taiwan, ROC.

Hung Ju Hou is a graduate student at National Central University, 300 Jhong-Da Rd., Jhong-Li City 320, Taiwan, ROC.

In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.

Spherical Crystallization for Lean Solid-Dosage Manufacturing (Part II)

As the industry continues to evolve, do we know where we're headed?

Unconventional Communication

The authors examined the disintegration and dissolution profiles of propranolol and rofecoxib tablets overencapsulated with standard hard-gelatin capsules and with capsules specifically designed for double-blind clinical trials.

The Effect of Overencapsulation on Disintegration and Dissolution

Editors' Picks of Pharmaceutical Science and Technology Innovations

In the Spotlight April 2010

Jane Wan is a freelance writer based in Singapore.

As demand for global vaccine development and production grows, all eyes are turning to Asia.

Report from Asia

Alice Laures is an analytical chemist in analytical sciences/chemical development at GlaxoSmithKline in the UK.

George Okafo is a manager in Scinovo, Preclinical Development at GlaxoSmithKline (UK).

Patrick Johnson is an analytical chemist in analytical sciences/chemical development at GlaxoSmithKline in the UK.

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes