Development

Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss their ‘wish list’ for the progression of trends in the bio/pharmaceutical industry.

Lonza will develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity in Iconovo’s pipeline.

Under a global alliance with the Australian non-profit GC4K and Weill Cornell Medicine, PackGene aims to deliver a custom-tailored gene therapy solution for hereditary spastic paraplegia type 56, an exceptionally rare neurological disease.

This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.

The new company will harness splicing technology to innovate safer and more effective RNA therapies for severe genetic diseases.

The $94 million (€90 million) Series A funding will be used to support the development of the company’s pipeline of nCycles, oral macrocycle drugs that will be focused on validated biologic targets.

The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

The companies will advance the development of Innovent’s ADC candidate, IBI3009, which has received IND approvals in the US, China, and Australia.

Atul Mohindra, head of Biologics R&D at Lonza, discusses the challenges and successes of bispecific antibodies as well as the field’s future direction from a CDMO perspective.

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.