Manufacturing

A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments.

PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for pharmaceutical technology transfer.

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.

FDA's 12-digit NDC rule demands industry-wide barcode, labeling, and data system overhauls, manufacturers must act now to avoid pharma's Y2K moment.

BioPhorum launches a 20-member collaboration uniting pharma, CDMOs, and regulators to address manufacturing challenges in small molecule drug production.

The outsourcing company is adding commercial-scale capabilities to manufacture HPAPI and ADC payload-linkers.

The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain.

Kristin Ciriello Pothier, KPMG US, discusses deal discipline, manufacturing diligence, and why oncology and GLP-1s are driving biopharma M&A activity in 2026.

The future of synthetic biology will depend not only on the ability to design biological systems, but on the capacity to manufacture DNA reliably at scale within regulated frameworks.

How the Lehigh Valley Economic Development Corporation is building a technical workforce pipeline to support Eli Lilly's 850-job pharmaceutical manufacturing expansion.

The aim of this study was to develop and optimize an orally dissolving film formulation containing a blend of active ingredients in a strategic combination of natural and synthetic excipients to achieve a balance between controlled actives release and rapid onset of action.

The scientific basis, regulatory expectations, validation approaches of hold times in biopharmaceuticals are presented along with real-world examples.

PharmTech Europe's June 2026 issue reflects the convergence of compliance burden, cost pressure, analytical complexity, and patient access.

Kristin Ciriello Pothier, KPMG US, discusses why pharma dealmaking slowed in early 2026, but how AI partnerships, manufacturing acquisitions, and oncology are driving a second-half rebound.

US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape pharma manufacturing investment.

First generic of single-dose flu drug baloxavir marboxil approved by FDA ahead of 2026–2027 season, expanding antiviral access and manufacturing competition.

A comprehensive approach to long-term sustainability efforts in pharmaceutical manufacturing should prioritize simpler frameworks that curb costs, risks, and variability.

Kristin Ciriello Pothier, KPMG US, explains why supply chain resilience and platform technology diligence are reshaping biopharma M&A valuations globally.

Webinar Date/Time: Thu, Jul 16, 2026 11:00 AM EDT

Duloxetine was recalled over excess nitrosamine impurity, renewing scrutiny of process controls across generic drug manufacturing.

Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the case-processing pipeline. End-to-end ICSR autonomy may enable near-instantaneous case processing so that current SUSAR targets become obsolete.

Kristin Ciriello Pothier, KPMG US, discusses biopharma dealmaking shifting toward strategic precision, with oncology, GLP-1s, and manufacturing complexity reshaping M&A valuations in 2026.

Tom Sellig, Adare, discusses 3D-printed tablets, US reshoring investment, FDA timeline pressures, and workforce development strategies driving CDMO growth.

GLP-1 / insulin demand is straining CDMO fill-finish capacity. This piece examines bottlenecks in automated pen injector assembly and strategies to optimize operations.

The standards organization’s annual drug shortages report finds drug shortages lasting longer and the number of discontinuations rising, but the number of shortages themselves have gone down.