Development

Advancements in bioprocessing and analytics are crucial to the future development of bispecific antibodies and beyond.

BioPharm International® spoke with Paul Mugford, director, Biologics Process Development at BIOVECTRA, to find out what approaches works best for optimizing processes in microbial fermentation.

The results garnered from the Phase IIb study failed to achieve statistical significance in the primary endpoint.

Nicolas Pivet, vice-president and general manager, Technology Solutions at Cytiva, discusses how automation benefits process development, particularly in the analytical space.

Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how process controls change during development through commercialization, how cell harvesting can be optimized, and which validation and/or qualification studies are performed for cell culture.

Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how cell culture processes may be optimized and what kind of process studies are performed for cell culture.

Using Orexo’s powder-based drug delivery technology, the companies will develop mucosal vaccines in an inhaled formulation.

Daniel Giroux, VP of Biologics Development at Abzena, discusses approaches for optimizing process development for the production of proteins.

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.

In the latest of a series of acquisitions this year, AbbVie will acquire Nimble Therapeutics, which includes that company’s lead asset, an oral peptide for treating psoriasis.

AbbVie has completed its $1.4 billion acquisition of Aliada Therapeutics, giving it access to Aliada’s disease-modifying therapy for Alzheimer’s disease.

In part two of a video interview, Colin McKinlay, PhD, senior director, Chemistry and Delivery Technologies, at Nutcracker Therapeutics, talks on current trends and the direction that mRNA–LNP development may take going forward.

In a discussion on mRNA and LNP development, Colin McKinlay, the senior director of Chemistry and Delivery Technologies at Nutcracker Therapeutics, points out current challenges and innovations that meet these challenges.

The companies will develop a platform that can enable rapid development of DPI products.

Under the deals, the parties will advance therapeutics for fibrotic diseases, osteoarthritis, and Alzheimer’s disease.

Under the deal, Novartis will in-license PTC518, an mRNA splice modulator for the huntingtin gene, which has the potential to be the first oral disease-modifying therapy for Huntington's disease.

Cambrex will provide Lilly’s biotech collaborators with accelerated access to clinical development capabilities.

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.