Daria G. Husni

John Bertagnolli, vice-president of Commercial Operations at Selkirk Pharma, discusses considerations when building and scaling up pharmaceutical facilities, including contamination control and aseptic processing challenges.

The organizations plan to combine etherna’s experience in mRNA and lipid-based nanoparticles with UHasselt’s autoimmune research to treat a variety of auto-immune diseases.

Breyanzi is made from the patient’s own T cells, which are genetically reengineered into CAR-T cells and then delivered through infusion as a one-time treatment.

The new drug delivery site will serve to increase Cresset's reach in the region, answering growing demands from its Asia-Pacific consumers.

The company presented results from its programs for Duchenne muscular dystrophy and facioscapulohumeral muscular dystrophy.

One of the first planned areas of focus is the field of preterm birth-associated early onset respiratory disease.

Mariana’s portfolio of radioligand therapies will strengthen Novartis’ radioligand therapy pipeline.

Key areas to invest include manufacturing process improvements, quality management, and AI.

Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.

The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies.

The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.

At INTERPHEX 2024, a panel of experts gave insight on new regulatory requirements for contamination control and provided advice for how to implement a contamination control strategy in existing facilities.

At INTERPHEX 2024, Wenyu Zhang, PhD, covered new trends in the aseptic industry and the key factors companies should consider while weighing their options.

This investment will bolster the company’s large-scale cell culture CDMO business at its planned Fujifilm Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina.

The collaboration aims to reduce manufacturing time and costs, allowing more access to specialized cancer treatments.

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

There are considerations companies may want to consider before seeking out a service provider.

AstraZeneca’s acquisition of Amolyt Pharma includes eneboparatide, a Phase III therapeutic peptide for the treatment of hypoparathyroidism.

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

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.

The acquisition will give Novartis full rights to CALY-002, Calypso’s lead product candidate.

With the acquisition, AstraZeneca will gain a potential RSV and hMPV combination vaccine.

Under the agreement, the companies will discover and develop drug candidates targeting two ion channels linked to neurological disorders.

A look into the latest developments in biopharmaceutical manufacturing and facilities.

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.