Formulation Development
Novavax Initiates Pivotal Phase 3 Clinical Trial
Novavax, Inc. recently announced the initiation of a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged…
Orgenesis Announces Co-Development Agreement With Accellix
Orgenesis Inc recently announced it has entered into a co-development agreement with Accellix, Inc. The agreement will enable Orgenesis to integrate Accellix’s proprietary optic system, cartridges, reagents,…
An End to Alzheimer’s? New Drugs Fight Memory Loss
Researchers in Toronto have developed an experimental drug that appears to renew the underlying brain impairments causing memory loss, fuelling hopes that a treatment for…
Patient-Derived Tumor Organoid Drug Development Platform Launched
Crown Bioscience recently announced the launch of a new tumor organoid drug development platform with the potential to significantly improve the……
White Paper: Control of Beta-Glucans & Endotoxin in High Purity Sucrose for Biopharmaceutical Applications
This white paper discusses a Quality by Design (QbD) scenario that allows end users to rationally select the well characterized excipients during biopharmaceutical development and develop a control strategy for biologic drug products.
White Paper: High Purity Low Endotoxin Arginine: Applications in Biopharmaceutical Processing & Biotherapeutic Stabilization
This white paper discusses arginine, also known as L-arginine (symbol Arg or R), a basic amino acid widely used in biopharmaceutical processing and stabilization of biotherapeutics.
Pfenex Receives US FDA Approval for PF708 to Treat Osteoporosis
Pfenex Inc. recently announced the US FDA has approved the new drug application (NDA) for PF708 submitted under the 505(b)(2) regulatory pathway, with…
Sienna Biopharmaceuticals Files 510(k) Submission With FDA
Sienna Biopharmaceuticals, Inc. recently announced the company has filed a Premarket Notification 510(k) submission to the US FDA for SNA-001, a topical pre-treatment to standard…
MilliporeSigma Becomes the First to Use Acoustic Technology for Cell Therapy Manufacturing
MilliporeSigma recently announced it has acquired FloDesign Sonics, of Wilbraham, MA, developer of a unique acoustic cell processing platform for the industrialization of cell and…
Akcea & Pfizer Announce $250-Million Licensing Agreement for Investigative Therapy
Akcea Therapeutics, Inc., a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Pfizer Inc. recently announced the companies have entered into a worldwide exclusive licensing agreement…
Streamlining Drug Development Processes Through the Accenture INTIENT Clinical Platform
To facilitate the demand for this new world order, we’ve unveiled the Accenture INTIENT Clinical platform. It helps companies run faster clinical trials with better transparency and….
Cue Biopharma Doses First Patient in Clinical Trial
Cue Biopharma, Inc. recently announced it dosed the first patient in a Phase 1 clinical trial of CUE-101 at Washington University, Alvin J. Siteman Cancer Center, St. Louis, Missouri for the treatment of….
Cabaletta Bio Receives IND Clearance From FDA to Initiate First Clinical Trial
Cabaletta Bio, Inc. recently announced it has received clearance of its IND application from the US FDA to initiate a first-in-human clinical trial of…..
Ocugen & CanSinoBIO Enter Strategic Co-Development & Manufacturing Partnership
Ocugen, Inc. has recently entered into a strategic partnership with CanSino Biologics on Ocugen’s gene therapy pipeline product candidates for inherited retinal diseases, which are…
Novel Silica Delivery System Enters Final Preclinical Development Stage
N4 Pharma Plc recently announced results from the company’s latest research study into its novel silica nanoparticle for cancer treatments and vaccines, Nuvec. The work,…
AGTC & Otonomy Announce Strategic Collaboration to Develop & Commercialize Gene Therapy
Applied Genetic Technologies Corporation and Otonomy, Inc. recently announced they have entered into a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to…
MODIFIED RELEASE - Alternative Strategies for Development of Modified-Release Dosage Forms
Andy Lewis, PhD, discusses a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing.
COMBINATION PRODUCT DEVELOPMENT - New Horizons in Development to Meet Emerging Demands
Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.
CHARACTERIZATION CORNER - A New Weapon in Formulation Development
Matt McGann explains how Microfluidic Modulation Spectroscopy is the final addition in the biophysical characterization scientist’s toolkit.
MICROFLUIDIC ENCAPSULATION - Controlling Drug Delivery With PLGA
Richard Gray, MA, discusses the use of polymer microparticles for pharmaceutical applications, including specific examples of polylactic-co-glycolic acid (PLGA) encapsulation.
