Drug Development

Unique solutions are required to protect inherently unstable messenger RNA.

This article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.

Considerable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.

The complexity of the RNA production process creates challenges.

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

Webinar Date/Time: Friday, April 28, 2023 at 11am EDT | 10am CDT | 8am PDT

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.

Webinar Date/Time: Thursday, May 11th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Webinar Date/Time: Tue, May 23, 2023 11:00 AM EDT

Despite the advantages intensified processes can offer developers, there are still some obstacles to overcome before broader application of new technologies will be implemented.

Impurities and batch-to-batch variability present the biggest challenges.

New child-friendly treatment options and initiatives are improving the outlook of children living with HIV in Europe.

FDA has spurred investment to create and develop 600 therapies.

Decreasing vein to vein time saves lives.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Webinar Date/Time: Thursday, April 20th, 2023 4:00pm GMT | 11:00 am EDT | 5:00 pm CEST

Webinar Date/Time: Tue, Apr 25, 2023 11:00 AM EDT

Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines.

Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.

BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.

Polyplus’ LipidBrick is designed to expand the scope of lipid nanoparticle formulation usage in mRNA therapeutics and vaccine development.

Stevanato Group will support development and production of pre-fillable syringes for use in Recipharm’s soft mist inhalers.

Predictive Oncology and Cancer Research Horizons have partnered to pursue development of cancer drugs utilizing the PEDAL platform.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.