Formulation Development
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.
2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery
In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
WEARABLE PLATFORM – Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution
Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
FORMULATION FORUM – Nanosuspension Dosage Forms: Product Development & Scale Up
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
EXCLUSIVE ONLINE CONTENT
Ascendia Once Again Ranked on Inc. 5000 List of America’s Fastest-Growing Private Companies
Inc. magazine revealed that Ascendia Pharmaceuticals rose 3,239 positions on its annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies…..
PCI Pharma Services Announces the Acquisition of LSNE to Add End-to-End Global Sterile Fill-Finish & Lyophilization Manufacturing Capabilities
PCI Pharma Services (PCI) recently announced it has signed a definitive agreement to acquire Lyophilization Services of New England, Inc. (LSNE), a premier contract development and manufacturing organization (CDMO)….
Pace Life Sciences Acquires Velesco Pharmaceutical Services, Expanding Capabilities in Drug Development Services
Pace Analytical Life Sciences, LLC, a subsidiary of Pace Analytical Services, LLC, a full-service contract development and manufacturing organization (CDMO), recently announced that it has acquired Velesco….
Centogene & Twist Bioscience to Develop Advanced Sequencing Tools to Make Genetic Testing Rapidly Accessible for More Patients With Rare Diseases
Centogene N.V. and Twist Bioscience Corporation recently announced they have signed a contract to collaborate on the development and commercialization of custom assay kits for rare diseases…..
Acer Therapeutics & Relief Therapeutics Announce FDA Acceptance for Filing of NDA
Acer Therapeutics Inc. and its collaboration partner, Relief Therapeutics Holding SA recently announced the US FDA has accepted for filing the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for the….