Formulation Development
FORMULATION FORUM - CUBOSOMES – The Next Generation of Lipid Nanoparticles for Drug Delivery
Jim Huang, PhD, and Shaukat Ali, PhD, shed light on the design and formation of cubosomes with special focus on their applications for delivery of hydrophobic and hydrophilic small and large molecules, including oncology drugs and polynucleotides (DNA, mRNA, and siRNA).
PLATFORM TECHNOLOGY - The PTXΔLNP® Platform: On the Promise of Developing New LNPs for Tomorrow’s mRNA Therapies
Charlotte Dunne, PhD, Katrin Radloff, PhD, and Leonidas Gkionis, PhD, review the PTXΔLNP platform and how it offers a synergistic sister technology to the mRNA platform to obtain potent mRNA-LNPs for therapeutic applications.
SOLUBILIZING & STABILIZING TECHNOLOGY - CAPTISOL® - Part Perseverance & Part Serendipity
Vince Antle, PhD, James Pipkin, PhD, and Lian Rajewski, PhD, say with decades of experience, proven safety, and recent and forthcoming authorizations in several new routes of delivery, the Captisol Team is looking forward to the next 2 decades and more of new drug products, new applications, and continued improvement in the technology.
BIOLOGICS DEVELOPMENT - Five Steps to a Robust Cell Line Development Process
Robert Gustines reviews the critical steps for designing and implementing a robust cell line development process to help overcome the obstacles that often hinder biologic production.
FUNCTIONAL EXCIPIENTS - Much More Than Filler: Solving the Challenge of Patient Non-Compliance
Carin Siow, PhD, explains how the progress to tackle the root causes of medication mis-use has been frustratingly slow and believes the pharma industry’s secret weapon in the fight against non-compliance are functional excipients.
Zevra Therapeutics Announces Interim Data From Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia
Zevra Therapeutics, Inc. recently announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic…
Assembly Biosciences Nominates Development Candidate ABI-6250, an Orally Bioavailable HDV Entry Inhibitor
Assembly Biosciences, Inc. recently announced the selection of development candidate ABI-6250 to progress to IND-enabling studies. ABI-6250, an orally bioavailable small molecule entry inhibitor, is…
EXECUTIVE INTERVIEW - HERMES PHARMA: Reducing Risk, Speeding Development - A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
PRIMARY CONTAINER CLOSURE SYSTEMS - In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
PLACENTA-ON-A-CHIP - The Future of Drug Discovery In Women’s Health
Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.
Evonik Strengthens Portfolio of Nanoparticle Technologies & Services for Parenteral Drug Delivery
Evonik is strengthening its platform of parenteral drug delivery solutions with three new standard PLA-PEG di-block copolymers and a new nanoparticle formulation service using….
Investigational Treatment for Fragile X Syndrome Receives Rare Pediatric Disease Designation From FDA
Shionogi & Co., Ltd. recently announced the US FDA has granted Tetra Therapeutics Inc. Rare Pediatric Disease Designation for zatolmilast (BPN14770), an investigational treatment being…
Omega Therapeutics Announces Promising Preliminary Clinical Data for OTX-2002 From Ongoing MYCHELANGELO I Trial
Omega Therapeutics, Inc. recently announced encouraging preliminary safety, tolerability, pharmacokinetic, and translational data from the initial two dose level cohorts (n=8) from Part 1 of its ongoing Phase 1/2 MYCHELANGELO I study evaluating….
Phathom Pharmaceuticals Announces Vonoprazan NDA Submission for Non-Erosive GERD
Phathom Pharmaceuticals, Inc. recently announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease (GERD)…
bYoRNA & Dyadic Announce a Collaboration Targeting the Production of Abundant, Low-Cost mRNA From C1-Cells
bYoRNA SAS and Dyadic International, Inc. recently announced they entered into a development and commercialization agreement to work on disruptive bioproduction technologies that will help…
SOHM Announces Acquisition of ABBIE, a World-Class Gene-Editing Platform That Can Deliver Genetic Payloads Using Non-Viral Vectors
With this acquisition, SOHM is well-positioned as a competitive player in the $5.3 billion gene-editing market in 2023. The gene-editing market is expected to grow….
MilliporeSigma to Become First Provider to Offer Fully Integrated mRNA Services
MilliporeSigma is the first CTDMO to offer integrated services for all critical stages of mRNA development, manufacturing, and commercialization, including products and….
AcuraStem Enters Into License Agreement With Takeda to Advance PIKFYVE Therapeutics
AcuraStem recently announced it has entered into a license agreement with Takeda to develop and commercialize AcuraStem’s PIKFYVE targeted therapeutics including AS-202, an innovative antisense oligonucleotide…
Coya Therapeutics Licenses Exclusive Worldwide Rights to Exosome Engineering Technology From Carnegie Mellon University
Coya Therapeutics, Inc. recently announced licensing of the exclusive, worldwide rights of a proprietary Exosome Engineering Technology from CMU with potential applications across multiple indications, including…
Clene Reports Significant Long-Term Survival Improvement From CNM-Au8 Treatment in HEALEY ALS Platform Trial Compared to PRO-ACT Historical Controls
Clene Inc. recently announced long-term follow-up data for patients treated with CNM-Au8 30 mg for up to 133 weeks in the HEALEY ALS Platform Trial.…
