In an interview, Fabian Gerlinghaus of Cellares outlines a paradigm change in both hardware and software, regulatory expansions, and some positive cost outcomes for the CGT field.

The Cell Shuttle platform will manufacture cell therapies for its first clinical trials by the end of the year.

The European company has seen its business increase by 47% in North America.

The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.

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

The facility producer’s new innovation hub will offer manufacturing, life sciences, and infrastructure services.

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

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

FDA has published final guidance documents regarding validation and development of analytical procedures.

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

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

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

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

The power of collaboration is a critically important for the bio/pharma industry.

Wider life sciences industries in the UK and Europe are receiving favourable financial support from governing bodies.

While Catalent’s acquisition is definitely about making drugs, it’s also very much about making money.

The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.

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

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

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

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.

GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.