The €4 million (US$4.3 million) project is current good manufacturing practice compliant, and includes an accompanying cartoning machine.

The detector features specialized, solid-state dual infrared (IR) sources and dual IR receivers which provide continual cross-checks and internal adjustments to adhere to factory calibration.

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

In an interview with Pharmaceutical Technology®, Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the M&A landscape from 2024 and his expectations of what is to come next.

The company said this blender supports applications for which either stainless steel or carbon steel may not be suitable.

In an interview with Pharmaceutical Technology®, Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.

The company first announced its intention to build the state-of-the-art facility as part of a €900 million investment in July 2024.

Brian Feth, Xcell Biosciences; Thomas Heathman, Ori Biotech; and Matthew Lauber, Waters Corporation go behind the headlines and discuss commercialization challenges in the cell and gene therapy space; advances in new genomics tools from Roche, Illumina, and Eikon; and the latest development and manufacturing partnerships.

Pharmaceutical Technology® discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer with Mike Baird from Schlafender Hase.

The company now performs product-sterility testing through rapid microbiological methods at two laboratory sites in the United States and one in Germany.

Xiao-Yan Cai, PhD, shares insights into her leadership style, the importance of motivation in the workplace, and how she balances repetition with innovation, discussing how hobbies and resilience uniquely shape her professional approach, emphasizing the value of perseverance and preparation in both science and life.

CHMP gave its opinion and a recommendation for marketing authorization to Fabhalta (iptacopan), an oral, Factor B inhibitor of the alternative complement pathway.

Compliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

Jaypirca (pirtobrutinib) has received a conditional marketing authorization from EMA for mantle cell lymphoma. The drug was approved in the United States in 2023 for several indications.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Regulatory clearances and approvals continue as agencies work to disseminate literature, raise awareness, redouble research efforts, and improve the efficacy of clinical trials.

Treatments for autoimmune diseases, multiple cancers, and skin blistering have been recommended for marketing approval.

Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes in an interview with Pharmaceutical Technology®.

Previous domestic capital expansion commitments since 2020 had been made in Research Triangle Park and Concord, both in North Carolina; Kenosha County, Wisconsin; Lebanon, Indiana; and Lilly’s home city of Indianapolis.

While the boards of directors of both companies have approved the transaction, it is not expected to close until the second quarter of 2025, as Mayne Pharma’s shareholders must still vote in favor of the acquisition.

Cerebrotendinous xanthomatosis, or CTX, is a metabolic disorder caused by a gene mutation that results in a deficiency of an important enzyme in the ability of the human body to break down fats.

Seladelpar, which is marketed in the US as Livdelzi, was recommended for an orphan drug designation by CHMP in December 2024.

The collaboration will utilize Genesis’ proprietary AI platform, initially focusing on targets selected by Incyte.

A capsule formulation may offer more consistent and reliable uptake versus a syringe, while being less dependent on food intake.

The AI co-scientist is a multi-agent AI system that can work as a virtual scientific collaborator.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

Pharmaceutical Technology® chatted with Preeya Beczek, managing director and co-founder of Beczek.COM, about industry trends from 2024 and which of those might impact the industry in 2025, including the big trend of AI.