Drug Development

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.

The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Webinar Date/Time: Session 1: Tuesday, February 28th , 2023 at 4pm GMT | 11am EDT | 5pm CEST Session 2: Wednesday, March 22nd, 2023 4:00pm GMT | 11:00 am EDT | 5:00 pm CEST Session 3: Thursday, April 20th, 2023 at 4 GMT | 11am EDT | 5pm CEST

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Webinar Date/Time: Thu, Mar 30, 2023 11:00 AM EDT

Webinar Date/Time: Thu, Apr 6, 2023 11:00 AM EDT

In this episode, Rhonda Henry and Adam Mendizabal from Emmes discuss the role CROs play in cell and gene therapies undergoing clinical trials at all stages.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Lipids aren’t the only important ingredients influencing stability and in vivo performance.