Feliza Mirasol

Andrew Lewis, PhD, Chief Scientific Officer, Quotient Sciences, discussed the CMC challenges with GLP-1 and oral peptides during CPHI Milan.

The nanofiber microcarriers are the first of their kind for manufacturing viral vectors used in gene therapy production, according to Cellevate.

As part of a range of sustainable products and services that SGD Pharma plans to showcase at CPHI Milan, the company will introduce its siliconized molded glass vials.

According to the survey results, 49% of industry respondents are “highly positive” on the contract services sector seeing growth over the next 18 months.

Solving the challenge of better-stabilized temperature-sensitive biomolecules hinges on innovative formulation strategies.

In this podcast episode, we discuss both the challenges of and the progress made so far by the biopharma industry toward non-parenteral means of delivering biologic drugs.

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

The approval of EBGLYSS (lebrikizumab-lbkz) by FDA puts a new biologic treatment for moderate-to-severe atopic dermatitis on the market for patients whose symptoms are not well controlled with topical treatments.

Lilly has added a $1 billion investment to increase biologics manufacturing at its Limerick, Ireland, site while unveiling its new $800 million facility in Kinsale.

Sartorius' new Vivaflow SU tangential flow filtration cassette offers better flexibility in lab workflows and is designed to be more user-friendly.

The 2024 CPHI Pharma Awards comprise finalists spanning 14 categories and includes awards for future leaders, women of the year, and an “at the heart of pharma” category.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

In this episode of Drug Digest, discussion with industry experts will highlight the challenges impacting aseptic processing and manufacturing, the intricacies of the regulatory landscape, and the necessity of addressing QC/QA early on, among other critical aspects.

Rentschler Biopharma has expanded its service offerings at its Stevenage, UK, site with a new lentiviral vector manufacturing toolbox.

Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.

The completed acquisition of Morphic expands Lilly's immunology pipeline with Morphic's oral integrin therapies for treating inflammatory bowel disease.

Merck, known as MSD outside of the United States and Canada, will gain CN201, a next-generation bispecific antibody, from Curon Biopharmaceutical in a deal potentially worth up to $1.3 billion.

With the agreement, Andelyin Biosciences will add MyoAAV plasmids developed by Broad Institute of MIT and Harvard to its AAV Curator Platform.

US Specialty Formulations plans to invest $15 million to expand biopharma operations at its Allentown, Pa.,facility.

BioIVT opened new cleanroom manufacturing space, using Germfree’s technology to boost its capabilities for cell and gene therapy development.

Manual and automated inspection technologies have their own advantages and limitations.

Freudenberg Medical has introduced custom single-use assemblies for silicone extrusion and molding for biopharma applications.

This acquisition gives AbbVie clinical-stage assets from Cerevel’s pipeline that complement AbbVie's emerging neuroscience pipeline and branded products for treating psychiatric disorders, migraine, and Parkinson's disease.

With the Series A funding, the new biotech company will advance the development of enhanced biologics for treating solid tumors and inflammatory and immunology diseases.

STADA and Alvotech have launched Uzpruvo in Europe, making it the first approved biosimilar to Stelara (ustekinumab) in the European market.

Scorpius Holdings is set to launch its first CGMP manufacturing campaign at its San Antonio, Texas, facility for mammalian cell culture in the 2024 third quarter.

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.

Univercells and the University of Pennsylvania are expanding their collaboration to evaluate certain bioreactors with the aim to scale up gene therapy manufacturing.

GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.

PluriCDMO, Pluri's newly launched CDMO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.