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

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.


Meeting E&L Expectations

Agnes Shanley is senior editor of Pharmaceutical Technology.

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.


DOE Gains Ground in Biopharmaceutical Development

This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.

Approaches to Reduced Sampling and Testing for Starting Materials

The new service will assist pharmaceutical companies with quality control and analytical requirements.

Recipharm Introduces New Stand-Alone Service

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.

Samsung Announces Manufacturing Agreement with Ichnos Sciences

Elizabeth Joseph is research scientist II, BioPharma Solutions at Baxter Healthcare Corporation.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

Residual Moisture Determination in Lyophilized Drug Products

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Adapting APIs for Specialty Dosage Forms

The company is expanding its bioanalytical capacity and capabilities to support biologic drug development, cell and gene therapy development, and biomarker analysis.

Frontage Expands Bioanalytical Capacity and Capabilities

Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.

Pfizer Recalls Batches of Docetaxel Injection

The root cause of NDMA contamination may go well beyond manufacturing problems, to the molecule itself.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes