Development

Innovation in this space depends on strategizing for GMP compliance and market access.

Experts believe it is likely cancer cells are more common in the body than previously thought, but typically caught early and removed in the body’s cancer-immune cycle. When the system is in good working order (and protecting us), dead cancer cells release neoantigens.

J&J’s nipocalimab is in development for reducing the risk of FNAIT in alloimmunized pregnant adults, a rare disease that may risk the life of the fetus or newborn.

AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.

AbbVie’s acquisition of Landos includes a lead asset that boosts its portfolio in autoimmune and inflammatory diseases, while the ADC, ELAHERE, gets full FDA approval.

Webinar Date/Time: Thu, Thu, Apr 18, 2024 11:00 AM EDT

Webinar Date/Time: Thu, Apr 25, 2024 11:00 AM EDT

Webinar Date/Time: Wed, May 8, 2024 11:00 AM EDT

ProBioGen and Mapp Biopharmaceutical will use the former’s GlymaxX technology to develop a cell line for an afucosylated antibody that targets Marburg virus infection

Under a new agreement, Chime Biologics will manufacture Domain Therapeutics’ antibody cancer immunotherapy candidate, DT-7012.

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

Johnson & Johnson’s $2 billion acquisition of Ambrx boosts its pipeline of next-generation ADCs for cancer treatment.

Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Despite a growing number of biosimilar approvals, market uptake remains a challenge.

Proprietary cell lines offer opportunities for achieving high AAV titers.

CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.

Webinar Date/Time: Thu, Mar 28, 2024 11:00 AM EDT

Nona Biosciences and Boostimmune will collaborate to develop ADCs against novel targets using Nona’s proprietary platform technology.

Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.

Webinar Date/Time: Wed, Mar 20, 2024 11:00 AM EDT

Webinar Date/Time: Thu, Mar 21, 2024 11:00 AM EDT

BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

Webinar Date/Time: Tue, Mar 5, 2024 2:00 PM EST

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.

Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.