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.

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Articles

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

Agnes Shanley is senior editor of Pharmaceutical Technology.

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

Problems With Ranitidine May Transcend Manufacturing Issues

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

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.


The Fundamentals of Dissolution Testing

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.


Overcoming Bioavailability ‘Roadblocks’ with LBDDS

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution. 

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes