Manufacturing

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

PharmTech Group chatted with Markus Laubscher of Orbia during DCAT Week 2025, covering the topics of sustainability, regulatory hurdles, next-generation innovation, and the DCAT Week experience.

Upgraded and dynamic valve platforms as well as advanced sensing will be some of the components of ITT’s exhibit.

Webinar Date/Time: Tuesday, 8 April 2025 | 11:00 AM EDT | 5:00 PM CEST

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection.

In an interview with Pharmaceutical Technology®, Michelle Bridenbaker from Unbiased Science discusses her thoughts on the key industry from 2024 and those she anticipates will impact the industry in 2025 and beyond.

Roquette Pharma Solutions' Christine Mya-San, global account manager, highlights the most significant pharma ingredients at play over the past year and discusses future ingredient innovation.

The company is highlighting its commitment to next-generation glass manufacturing in efforts to strengthen the pharmaceutical supply chain.

Russell Miller, vice-president of Global Sales & Marketing at Enzene, explains that continuous bioprocessing is poised to change biologics manufacturing moving forward.

PharmTech Group interviewed Lee Karras of Noramco live on site at DCAT Week 2025, shortly after the company announced a $25 million investment in sterile injectable manufacturing capabilities at its Halo Pharma facility in New Jersey.

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, discusses the challenges with maintaining aseptic integrity in sterile injectable pharmaceutical manufacturing.

Pharmaceutical Technology® sat down with Tore Bergsteiner from MAIN5 to discuss the most pertinent and impactful bio/pharma industry trends from 2024.

The partnership aims to develop and commercialize a novel checkpoint inhibitor for immuno-oncology applications.

The Member Company Announcement Forum is the kickoff event of the annual DCAT Week in New York City, which is being held from March 17–20.

Pharmaceutical Technology® spoke with Peter Belden, president of Tjoapack US, ahead of DCAT Week 2025 to discuss recent innovations in bio/pharmaceutical packaging.

As part of our coverage of this year’s DCAT Week, Pharmaceutical Technology® spoke with Hamilton Lenox, chief commercial officer at LGM Pharma about the expanding pharma market and the challenges such demand creates.

In an interview with Pharmaceutical Technology®, Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.

The multi-year strategic partnership is intended to support commercial demand of Viking Therapeutics’ GLP-1 candidate, VK2735.

Industry 4.0 is driving adoption in the pharma industry for smart equipment and tools that will advance manufacturing.

The company’s 100,000-sq.-ft. space is expected to enhance its capabilities for commercial oral dose treatment manufacturing in a variety of therapeutic areas.

Sterimove will make its North American debut at the April 1–3, 2025 event.

Webinar Date/Time: Wednesday, April 2, 2025 11:00 AM EST

The investment is intended for the Halo Pharma facility in Whippany, NJ, and aims to help relieve capacity shortages in the injectable supply chain in the United States.

Pharmaceutical Technology® chats with Miguel Forte from ISCT and Kiji Therapeutics about expectations for 2025 and the future technology agenda for industry.

Continuous manufacturing offers advantages in both biotherapeutic and API manufacturing but still poses challenges.

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.