Manufacturing

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

In this exclusive Drug Digest video, Adi Kaushal from Lonza summarizes the current state of the oral solid dosage market, identifies the main challenges to drug developers, explains how CDMOs are leveraging expert techniques to improve OSD bioavailability, and looks into the future of advancements in drug delivery.

Jamie Baumgartner, Jonathan Grinstein, and John Wilkerson go behind the headlines to discuss the implications of personalized gene-editing therapies, more HHS policy and funding updates, and the latest tariff-related investments.

Six winners and two honorable mentions were revealed at ISPE’s Europe Annual Conference in London.

The proposed $700 million, 700,000-square-foot space will support the companies’ future joint portfolio of next-generation obesity medicines.

The company said the investment is in response not only to customer demand and a belief in the value of US-based innovation, but also because of the trend toward US onshoring brought about by new tariff policies.

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

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.

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.

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.

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.

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.

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

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

Incorporating sustainable practices into process designs as early as possible ensures optimal performance.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Webinar Date/Time: Thu, May 22, 2025 11:00 AM EDT

Donald Ingber, MD, PhD; Miguel Forte, MD, PhD; Ali Pashazadeh, MRCS, MBA; and Adam Inche, PhD, MBA go behind the headlines to examine the fast-changing landscape of manufacturing re-shoring, tariffs, NIH budget cuts, and the outlook for cell and gene therapies.

The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.

The commitment will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple states.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.