Formulation and Drug Delivery

The market potential of nucleic acid-based therapies have been pushed into the spotlight following the success of the COVID-19 vaccines.

E&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.

Process control is essential for using continuous hot-melt extrusion to enhance solubility.

In this episode, Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Gregor Kawaletz, head of Oral Solid Dose Business Unit at Recipharm, discusses the immediate future of oral biologics

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

The recent success of mRNA vaccines has opened the door for further and future development of nucleic acid-based therapies.

Actions combatting the next pandemic must be diverse, reliable, and sustainable.

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.

Nicole Lewis, PVP Program Manager at Boston Children's Hospital, discusses the science behind precision vaccines, a form of personalized vaccines.

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

Alternative approaches to freeze-drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

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

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.

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.

Webinar Date/Time: Tue, Apr 4, 2023 11:00 AM EDT

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

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

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.