Development

The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.

Dyadic International has announced its collaboration agreement with Serum Institute of India for the development and manufacture of up to 12 antibodies and vaccines using Dyadic’s C1 gene expression system.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

Lonza will provide development and manufacturing services to two of Alector’s neurodegeneration drug candidates.

Samsung BioLogics will provide contract development organization services to drug developer GI Innovation.

The companies have entered into a sub-licensing agreement to develop products based on Dyadic’s C1 expression platform and Alphazymes’ enzyme technology.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Pharma delivers a positive message with renewed efforts to eradicate malaria.

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.

Getting the science right helps biopharma startups overcome development and commercialization challenges.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

Drug makers continue to explore innovative ways to develop antibody-drug conjugates based on their unique potential to neutralize cancer cells.

A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.

The company has launched a comprehensive portfolio of custom cell biology solutions and a new cell-line engineering technology.

The collaboration will apply artificial intelligence and machine learning to the development of drugs for treating a range of cancers.

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.

PDC*line Pharma has entered into a licensing agreement with LG Chem to develop a lung cancer vaccine in Asia.

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.

Findings from the Los Angeles Biomedical Research Institute could enable a new generation of anti-infectives.

Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of €1.5 million, which will be used to develop a new class of antibiotics to tackle AMR.

Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.

The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.

Jessica Rousset, chief operating officer, CURE Pharmaceutical, highlights some key regulatory considerations developers should keep in mind when approaching alternative dosage forms.