Manufacturing

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.

Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.

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

The bio/pharma industry is evolving with intention, intelligence, and a growing sense of shared purpose.

The company’s intent is to establish Merck Wilmington Biotech as the future United States home for producing Keytruda for US patients.

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

AnalytiChem has launched the Redipor line of ready-to-use culture media, which brings three well-known brands under one global brand.

Webinar Date/Time: Tue, May 20, 2025 2:00 PM EDT

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.

Webinar Date/Time: Thu, May 15, 2025 11:00 AM EDT

Paige’s state-of-the-art foundation models will be integrated with Sonrai’s intuitive cloud-based data analysis and bioinformatics platform.

The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.

Novartis will invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities and a new research hub.

The spray-dried formulations for Ethris’ mRNA vaccine candidates will be developed at Lonza’s Bend, Ore., Center of Excellence in accordance with GMP standards.

Rising demand for peptide-based therapeutics prompts the launch of this new peptide research center, which will offer services across peptide synthesis, discovery, and advanced modalities.

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

Wider adoption of single-use technologies and systems is aligning with sustainability goals for the industry.

Process consistency and robustness, analytical excellence, and regulatory compliance are essential in the scale-up of biosimilars.

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

Nicole Hunter, head of Global WMArchitect at WMFTS, sat with the PharmTech Group at INTERPHEX 2025 to discuss the industry initiative around single-use assembly components that was prompted by the supply disruptions caused by the COVID-19 pandemic.

At INTERPHEX 2025, the PharmTech Group spoke with Dave Loula, global product director, ITT Engineered Valves, about innovation in advanced sensing technologies that answer customers' need for reliable valve function.

Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, sat down with the PharmTech Group at INTERPHEX 2025 to discuss the design and critical role of walk-in chambers in the bio/pharmaceutical industry.

Speaking at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, discusses the practical benefits of functional labels in protecting parenteral drugs.

Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.

BioPure’s BioClamp connector has been upgraded and is now manufactured to be 13% lighter than the previous model, allowing users to achieve a 26% reduction in carbon dioxide emissions across the full lifecycle of a product.

With up to 88 channels, the CytoFLEX mosaic Spectral Detection Module offers enhanced detection.

Sherwin-Williams will showcase its advanced coating systems, which are designed to ensure safety, sterility, and efficiency in pharmaceutical manufacturing environments.

Having completed its €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 driven the growth of Slovenia’s workforce.

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.

The addition of the two larger-volume bioreactor sizes to Cytiva’s Xcellerex X-platform portfolio will allow scientists and researchers to scale up from 50 L to 2000 L to meet growing demand for clinical trials and regulatory approved products.