Development

Intravenous administration of amivantamab is the currently approved route, but a Phase III trial showed that subcutaneous treatment was non-inferior.

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products.

In a peer-reviewed study, Lantern Pharma said its AI-driven approach successfully identified 82 promising ADC targets, and 290 target-indication combinations.

If the conditions prove optimal, 2025 could be a prosperous year for bio/pharma business deals.

Under this collaboration, GSK and Oxford will combine their complementary expertise in the immune system, vaccines, and cancer biology.

The approval makes Enhertu (fam-trastuzumab deruxtecan-nxki) the first HER2-directed therapy in the United States for treating HER2-low or HER2-ultralow metastatic breast cancer.

The 2025 Pharmapack Awards recognize both commercial products and innovations that are shaping the future of pharmaceutical packaging.

Webinar Date/Time: Thu, Feb 13, 2025 11:00 AM EST

Webinar Date/Time: Wednesday, February 12th at 11:00 AM EST

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.

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.