Development

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.

This collaboration aims to advance a first-in-human clinical study by using autologous iPSC technology.

Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.

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.

Through this collaboration, Circio will combine its circVec DNA vectors with Entos’ Fusogenix PLV delivery technology, which is expected to enhance delivery efficiency and reduce toxicity.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

Hurdles exist across all aspects and phases of drug development and manufacturing.

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.

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.

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.

The company said the Stratyx 250 is the first bioreactor of its kind to offer biotech companies a combination of automation, remote process control, and flexibility.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

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 £10 million (US$13 million) investment is part of a larger £58 million (US$75 million) Series A financing round to be used for the development of Maxion Therapeutics’ preclinical lead program for treating inflammatory diseases.

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.

With the investment, AstraZeneca will establish a second global strategic R&D center in Beijing as well as support major research and manufacturing agreements to further advance life sciences in the country.

EsoBiotec’s proprietary lentiviral platform primarily enables the immune system to attack cancers but could ultimately offer patients cell therapy treatments delivered in minutes rather than several weeks.

BioPharm International® spoke with Alison Moore, chief technical officer, Codexis to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.

Under the agreement, Shilpa will undertake development and commercial supply for a novel checkpoint inhibitor for immuno-oncology indications.

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.

In the second half of an interview with Edwin Stone, PhD, CEO of Cellular Origins, Stone discusses how automation in CGT manufacturing can increase productivity without displacing human workers.

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.

Edwin Stone, PhD, CEO of Cellular Origins, offers his unique perspective to the challenges facing CGT manufacturers, drawing on his background in robotics and life science automation.

The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.

Exosomes, polymeric nanoparticles, and DNA nanostructures offer many potential advantages.

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

BioPharm International® spoke with Jason Bock, founder and CEO of CTMC, to find out about the newest cancer treatments, specifically developments in tumor-infiltrating lymphocytes.

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