Formulation Development
WHITEPAPER – Must-Use Strategies to Successfully Transfer & Scale Your Pharmaceutical Product
Bora’s Technology Transfer Whitepaper will help you discover key strategies to successfully transfer and scale Rx & OTC drugs.
WHITEPAPER: Lonza Engine® & Xcelodose®: Accelerating Preclinical & Clinical Trial Pathways With Target Dosing Technologies
Learn how Lonza helps developers quickly assess new drug candidates while minimizing API consumption through efficient excipient screenings, encapsulation and early-phase clinical development technologies. Drug…
2021 Analytical Testing eBook – Bioanalytical Testing is Fastest Growing Sector
In this annual Drug Development & Delivery analytical ebook, we present best practices in stability studies as well as the benefits of UPLC optimization…..
SPECIAL FEATURE – Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
FORMULATION DEVELOPMENT – A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
Masumi Dave, PhD, and Rollie Fuller monitor in this study ASA hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, they assess the impact of the excipient choices on the stability of ASA.
GENE THERAPY – Solving the Puzzle: Aligning the Pieces of Gene Therapy & Creating Success for Patients
Sue Washer, MBA, reviews the various elements that must come together in developing safe, effective, and commercially viable viral-based gene therapies.
NASAL SPRAY BIOEQUIVALENCE – Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
DRUG DEVELOPMENT EXECUTIVE – Poseida Therapeutics: Creating the Next Wave of Cell & Gene Therapies With the Capacity to Cure
Eric M. Ostertag, MD, PhD, CEO of Poseida Therapeutics, discusses the company’s innovative approach to develop safer, more effective, accessible and affordable cell and gene therapies for patients.
DIGITAL CUSTOM PLATFORM – PCI Pharma’s Digital Transformation: Reaching New Levels of Customer Experience
Wayne Hull and Rebecca Coutts, PhD, explain how incorporating digital transformation as core to their company’s business strategy was a decision based on increasing evidence that investment in digital solutions provides real and measurable returns.
HOT MELT EXTRUSION – API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.
EXCLUSIVE ONLINE CONTENT
Enteris BioPharma Launches Enhanced Website Showcasing Full Suite of Bench to Market™ Services
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), recently announced the launch….
F-star Announces Issuance of US Patent Protecting FS118, a Bispecific Antibody Targeting PD-L1 & LAG-3
F-star Therapeutics, Inc. recently announced the USPTO has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors…..
Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients
Spero Therapeutics, Inc. recently announced the company and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US….
Kinnate Biopharma Inc. Announces FDA Clearance of Investigational Drug Application for KIN-3248
Kinnate Biopharma Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for KIN-3248, a next-generation….
Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
Revive Therapeutics Ltd. recently provided an update on the company’s US FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with….