Manufacturing, Cell Therapies

Timing is everything, and it might be ideal for acceleration of real-time monitoring solutions.

Autologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.

Scientific innovation and regulatory reformations are helping to drive the global biopharma market forward, but a balance between cost and value still needs to be accepted for widespread adoption.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

The need for improved analytics grows.

A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.

Avid Bioservices is building a viral vector development and manufacturing facility near its existing biologics manufacturing facility in California.

Repligen and Navigo’s novel ligand could be the first to address antibody aggregation in low pH elution buffers.

AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

The industry considers applying automation and digitalization lessons learned during the COVID-19 pandemic to enhance workflows.

Corning’s new Ascent fixed bed reactor (FBR) system is an automated bioproduction platform designed to significantly improve yields and reduce bioproduction costs.

The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).

Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.

Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.

Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.

AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.

Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.

PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.

BioNTech will acquire a TCR cell therapy R&D platform as well as a manufacturing facility in Gaithersburg, Md., from Kite, a Gilead company.

Nkarta will establish a new combined scalable NK cell therapy manufacturing facility and corporate headquarters in South San Francisco, Calif.

Cellares has entered into a strategic relationship with Poseida Therapeutics to advance a closed, automated, and scalable cell therapy manufacturing system.

The companies work to develop and supply advanced cell models that better reflect an in-vivo environment to improve drug discovery accuracy and efficiency.

The GMP facility is designed to maximize bioprocessing efficiency of newborn stem cells and manufacturing at scale.

Gene therapy products present a unique set of challenges for the control of host cell protein impurities.

Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

New challenges in extractable and leachable studies for cell and gene therapy products.

Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs.

The Cell and Gene Therapy Catapult will establish offices and laboratories in Edinburgh, Scotland.