Formulation Development
CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm
John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
FORMULATION FORUM - Orally Disintegrating Tablets
Shaukat Ali, PhD, and Jim Huang, PhD, say as more NCEs are being discovered, the industry is weighing all options for evaluating those molecules in different dosages to improve solubility and oral bioavailability. With requirement for taste-masking of bitter drugs with commercially available ODT excipients, it poses additional challenges for improving taste-masking and performance of molecules for the intended usages.
PRECLINICAL SCREENING PLATFORM - From Preclinical Screening to Clinical Optimization: Accelerating Poorly Soluble Drug Development
Andrew Parker, PhD, John McDermott, and Sandeep Kumar, PhD, believe the development of poorly soluble drugs remains a significant challenge in pharmaceutical R&D. However, by adopting an adaptive approach that integrates services from preclinical screening to clinical optimization, developers can achieve significant time- and cost-saving benefits.
LIPID FORMULATION DEVELOPMENT - Why Softgels Are the Technology of Choice
Dipanwita De, PhD, and Kaspar van den Dries say solubility and bioavailability in OSD formulations remain major challenges within the early stages of drug development. While technological innovations have allowed the pharmaceutical industry to make progress in solving this hurdle, choosing formulations that help achieve desirable solubility and bioavailability can help speed up development of the most promising molecules.
EXCIPIENT TECHNOLOGY - Driving Oral Drug Delivery Innovation With Safe, Reliable Lipid Excipients
Nick DiFranco, MEM, says amidst the uncertainty of novel ingredients and formulation techniques, lipid excipients provide a safe, proven platform for enhancing in vivo formulation performance, enabling innovation without sacrificing scalability or regulatory confidence.
CLINICAL TRIALS - Keeping Pace With Shifting Drug Development Paradigms for Multi-Indication Therapies
Simon Bruce, MD, and Jack L. Martin, MD, indicate that as developers increasingly embrace multi-indication development, the success of multi-indication therapies will stem not merely from pipeline adjustments, but also from development strategies designed with multi-indication objectives at their core.
EXECUTIVE INTERVIEW - Intensity Therapeutics: Providing Cancer Patients With Treatments That Work
Lew Bender, Founder and CEO of Intensity Therapeutics, discusses the company’s science, clinical program, the drug development process, and more.
Salipro Biotech Strengthens Global IP Portfolio With Two New Patents
Salipro Biotech AB recently announced the issuance of two new patents by the Japanese Patent Office. These patents further solidify the company’s intellectual property (IP)…
Resalis Therapeutics Reports Durable, Fat-Selective Weight Loss With RES-010 in Non-Human Primates
Resalis Therapeutics recently presented new preclinical results on its lead candidate RES-010, a first-in-class antisense oligonucleotide targeting microRNA-22 (miR-22). The data was presented at the European…
GLD Partners LP Launches New Biotech Company to Accelerate Drug Discovery for Muscle-Wasting Diseases
GLD Partners LP recently announced the launch of Altagenics, a new biotechnology company leveraging Heligenics’ proprietary GigaAssay platform to accelerate drug discovery. The collaboration will initially…
RheumaGen & SiVEC Biotechnologies Announce CGT Partnership & In Vivo Program to Cure Common Autoimmune Diseases
RheumaGen, Inc. and SiVEC Biotechnologies, Inc. recently announced a licensing and joint development agreement for a breakthrough class of gene-editing therapies designed to cure autoimmune…
Terumo Announces Completion of Acquisition of WuXi Biologics Drug Product Plant in Leverkusen, Germany
Terumo Corporation recently announced the successful completion of its acquisition of a Drug Product Plant and associated Quality Control Laboratory operations from WuXi Biologics in Leverkusen,…
WHITE PAPER - An Insoluble Problem? Overcoming Oral Drug Solubility Challenges With Functional Polymers
There are three key factors that need to be controlled when designing a drug product for solubility enhancement: the polymeric carrier; the manufacturing process; and the match to the desired API. By controlling these three factors bioavailability, drug release profile and manufacturability of your final drug product can be controlled.
NanoPhoria Bioscience Secures Funding to Advance Breakthrough Heart Failure Therapy & Expand Portfolio for Novel Nano-in-Micro Delivery Platform
NanoPhoria Bioscience recently announced the successful first close of its €83.5 million Series A financing round. The round was led by XGEN Venture, Sofinnova Partners,…
Oculis Accelerates Privosegtor Into Registrational Trials in Acute Optic Neuritis, Pioneering the Path for a Potential First-in-Class Neuroprotective Therapy
Oculis Holding AG recently announced the advancement of Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the US FDA. Privosegtor…
Dyadic Applied BioSolutions Announces Milestone Achievements & Recent Company Developments
Dyadic International, Inc. recently announced the achievement of additional milestone payments in its collaborations with Proliant Health & Biologicals in life sciences and Inzymes ApS…
Invivyd Announces US IND Clearance & Alignment With FDA on Pivotal Clinical Program for a Vaccine-Alternative Antibody to Prevent COVID
Invivyd, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application and provided feedback to advance the company’s REVOLUTION clinical…
uniQure’s Gene Therapy for Huntington’s Disease Holds Blockbuster Potential
uniQure recently announced that its novel gene therapy, AMT-130 (ifezuntirgene inilparvovec), demonstrated statistically significant disease slowing in a Huntington’s disease (HD) pivotal trial. The results…
Polyrizon Announces Positive Pre-Clinical Results: PL-14 Demonstrates Encouraging Allergen-Blocking Efficacy
Polyrizon Ltd. recently announced encouraging results from a recent pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation. The study was designed…
