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.
DELIVERY DEVICE – Aerosol Deposition Characterization of Innovative PureHale® Technology Targeting the Upper Airways
Degenhard Marx, PhD, Fotos Stylianou, PhD, and Stavros Kassinos, PhD, explain how PureHale provides a modern device option for the delivery of a fine mist for a variety of solutions to only the upper respiratory tract without significant deposition in the lungs and lower airways.
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.
ADVANCED STOPPER SOLUTION – PremiumCoat®: Proven Compatibility With Current Vial Standards
Sebastien Cordier, Bruno Morchain, and Estelle Verger review how PremiumCoat combines state-of-the art elastomer formulation with market-proven film-coating technology to create a highly advanced stopper solution.
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.
OPEN INNOVATION PLATFORM – Beyond the Rule of Five: Scouting for Novel Formulation Approaches to Enable the Subcutaneous Application of Molecules With Poor Drug-Like Properties in Preclinical Research – Facilitated Through opnMe.com
Ines Truebenbach, PhD; Menorca Chaturvedi, PhD; Markus Koester, PhD; and Achim Grube, PhD, are looking for proposals that would provide innovative formulation approaches to facilitate the subcutaneous application of bRo5 molecules in a preclinical setting.
DRUG DEVELOPMENT EXECUTIVE – Enteris BioPharma: How to Build a Preferred CDMO Partner
Dr. Paul Shields, COO of Enteris BioPharma, discusses the changing face of the CDMO industry and how his company plans to leverage its newly expanded CDMO operations to take advantage of a variety of growth opportunities to build deeper partnerships.
EXCLUSIVE WEBINARS
Celanese Live Webinar: Engineering Drug Delivery to Improve Therapeutic Outcomes
Celanese and ThermoFisher Scientific have partnered together to present the value of the VitalDose® EVA drug delivery platform and manufacturing through Hot Melt Extrusion (HME) on September 9, 2021.
Where Do We Stand on Poorly Soluble Drugs and Peptides in Oral Delivery?
The Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
ILC Dover’s NEW Aseptic Isolator System – soloPURE™ – Sign Up Today
With the development of ILC Dover’s new Aseptic Isolator system new opportunities have opened up for many organizations who were previously able to conduct fill finish activities due to facility restraints or expensive closed barrier systems. This new technology….
Quotient Sciences: Upcoming Solubility Enhancement & Pediatric Development Webinars
Access our webinars on solubility strategies & pediatric drug development….
EXCLUSIVE WHITEPAPERS
E-book – Five Dangers of an Insecure API Supply Chain
Securing your API supply chain is key when managing the manufacture and delivery of your products, and a minor delay can derail a whole project. Learn what to look out for and how to prevent it happening to you.
New Opportunities for Oral Sustained Release Formulations With Polyvinyl Alcohol
This white paper describes the use of PVA-based Parteck® SRP 80, a functional excipient specifically developed for matrix-based sustained release oral solid dose formulations.
WHITEPAPER – Getting to the Clinic: 6 Steps to Build a Smart Clinical Filling Strategy
The transition from preclinical to clinical development is one of the most crucial stages in the life cycle of a drug product. Decisions made during this stage lay the groundwork for a compound’s success at many key downstream milestones, from regulatory submission, to commercial scale-up, and beyond.
FORMULATION FORUM – A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
In this study, the authors monitor acetylsalicylic acid (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 the ASA.
Outsourcing Drug Development & Production: Technology-Driven Drug Delivery Systems for Small Molecules at Losan Pharma
Due to the increasing demand for drug delivery systems that are able to improve the properties of low soluble, poor permeable, or highly dosed new and existing drug substances, technology-driven CDMOs can offer a wide range of technology platforms to overcome such challenges….
EXCLUSIVE ONLINE CONTENT
SomaLogic Announces Strategic Collaboration With UPMC to Tailor Clinical Care Through Proteomics Technology
SomaLogic recently announced a strategic collaboration with leading health system UPMC to explore how the large-scale study of proteins and….
ProQR Announces Axiomer RNA Editing Licensing & Research Collaboration With Lilly
ProQR Therapeutics N.V. recently announced a global licensing and research collaboration with Eli Lilly and Company (Lilly) focused on the discovery, development, and….
Longeveron Partners With Kinesiometrics to Create & Implement Cutting-Edge Smart Phone App to Measure Physical Responses to Cell Therapy
Longeveron Inc. has entered into an agreement with Kinesiometrics Inc., to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality….
AzurRx BioPharma Announces Acquisition of First Wave Bio & its Proprietary Niclosamide Formulations Targeting Multi-Billion Dollar Inflammatory Bowel Disease Indications
AzurRx BioPharma, Inc. recently announced it has entered a definitive agreement to acquire First Wave Bio, Inc. in a stock and cash transaction valued at….
ABITEC Corporation & Larodan AB Announce Brand Refresh After Successful Integration of the Two Companies
ABITEC Corporation, an ABF Ingredients company, recently announced in July 2020 the acquisition of Swedish manufacturer and international marketer of state of the art, high-purity research grade lipids, Larodan AB….
MacroGenics Announces Final Overall Survival Results From SOPHIA Study of MARGENZA in Patients with HER2-Positive Metastatic Breast Cancer
MacroGenics, Inc. recently announced the final overall survival (OS) results of the SOPHIA Phase 3 study in adult patients with metastatic HER2-positive breast cancer…..
Medrio, Inc. & PHASTAR Unite to Offer Data Visualization for Clinical Trials
Medrio and PHASTAR recently announced they have partnered to leverage metadata surrounding electronic patient-reported outcomes (ePRO) for advanced data visualization, providing insight into….
Nature Medicine Publishes Positive Phase 3 Anakinra Study Results in Patients With COVID-19 Pneumonia
Swedish Orphan Biovitrum AB (Sobi) and the Hellenic Institute for the Study of Sepsis recently announced that Nature Medicine has published positive results from the investigator-sponsored Phase 3….
Impel NeuroPharma Announces US FDA Approval of TRUDHESA Nasal Spray for the Acute Treatment of Migraine
Impel NeuroPharma, Inc. recently announced the US FDA approved TRUDHESA (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura….
A Collaborative Effort Paves the Way for a New Approach to Small Batch Manufacturing
In today’s pharmaceutical industry there is a sharp focus on the needs and requirements of the patient. More and more drugs are being developed for specific patient groups. Orphan drugs, for example,….
