Development

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

Lonza’s new tailored offering leverages the company’s bi-layer capsule manufacturing technology.

Jason Bock, co-founder and CEO of CTMC, discusses the industry impact and manufacture of patient-centered medicines.

The agency will review the company’s supplemental new drug application for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy.

Webinar Date/Time: Tue, Dec 3, 2024 Session 1: 9:00 am EST | 1:00pm GMT | 2:00pm CST Session 2: 2:00 pm EST| 1:00pm CST| 11am PST

Webinar Date/Time: Thursday, December 5th, 2024 at 11:00 AM EST

Under the collaboration, the companies will create and test circVec DNA–LNP formulations with an eye toward potential therapeutic applications.

Webinar Date/Time: Thu, Dec 12, 2024 11:00 AM EST

Eisai Europe and Biogen have received a positive opinion for the monoclonal antibody therapy to be used as a treatment of adult patients with early Alzheimer’s disease.

Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST

Avantor has launched its new, expanded Innovation Center in Bridgewater, NJ, with integrated workflows under one roof and purpose-built collaboration spaces.

Avantor executives discuss the future of the biopharmaceutical industry and the impact that a wave of next-generation biotherapeutics will bring.

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.

Under an agreement, Leads Biolabs has granted the new company, Oblenio Bio, an exclusive option to license LBL-051, a tri-specific T-cell engager antibody.

Lonza’s Synnafix has licensed its ADC technology to BigHat Biosciences, which will combine it with its ML design platform to generate newly designed ADCs.

The Novo Nordisk Foundation has committed DKK 600 million (US$87.4 million) towards the initial costs of the center housing the new supercomputer, which has the potential to accelerate drug discovery innovation.

The collaboration aims to develop precision genetic medicines using ViaNautis’ proprietary polyNaut technology platform.

The company is investing $76 million to increase ADC manufacturing capacity at its St. Louis, Mo. facility.

The companies expect to accelerate the clinical development of MRT-6160, a Phase I drug candidate, as well as explore further therapeutic opportunities across multiple indications.

Merck is acquiring the Yale-spinout, which develops direct DNA modification-enabled cancer treatments.

The Cambridge-GSK Translational Immunology Collaboration builds on an existing scientific relationship between the biopharma company and the university, with the aim of improving outcomes for patients.

At AAPS PharmSci 360.Bala Addepalli, PhD, Director, R&D New Modalities Portfolio, Waters Corporation, discussed trends in new analytical tools for RNA characterization and gave highlights from his presentation.

Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, discussed lipid-based formulations and tackling bioavailability challenges for oral biologics at AAPS PharmSci 360.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Webinar Date/Time: Thu, Nov 7, 2024 11:00 AM EDT

Through the collaboration, Merck will use Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

The establishment of this new center aims to expedite R&D processes, reduce costs, and potentially lead to accelerated discovery of new candidate therapies.