Articles

Poor API quality may often lead to delays in production and a shortage of supply.

Poor API Quality Threatens a Healthy Supply

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with the current standard of care, according to a phase III trial.

EU Approves AstraZeneca Mantle Cell Lymphoma Treatment

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

Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.

Parenteral Formulation: Deciding When to Go Frozen or Freeze-Dried

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

Videos

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.

Industry Outlook 2025: European Political Impacts on the Supply Chain

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

New CBER Director Appointed

, is senior manager, Manufacturing Science and Technology (MSAT), at AGC Biologics.

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

Understanding the Variability in Bioburden Test Results in Biomanufacturing

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.

Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.

AAPS National Biotechnology Conference 2025: High-Concentration Biologics

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the biopharma industry in the future.


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