DRUG DELIVERY – CAPRO(TM): A New Advance in Polymeric Drug Delivery
Bob Wieden and Chun Wang, PhD, discuss how significant challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel polymeric drug delivery platform that overcomes a great many bioavailability and delivery obstacles.
DEVICE DEVELOPMENT – Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk
Nicolas Bralet and Megan Lan, MBA, MA, discuss how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
MANUFACTURING SOLUTIONS – Sterile Drug Product Manufacturing During a Global Pandemic
Ankit Agrawal, MSc, Ronald Aungst, Jr., PhD, Jonothan Hamer, MCIPS, and Barbara Solow, PhD, say with vaccines and treatments now available and yet more on the horizon, the first major manufacturing hurdles have been crossed; however, the finish line is still in the distance.
SYRINGE PLUNGER – Exploring How the Functional Properties of the PremiumCoat® 1-3-mL Plunger Facilitate its Implementation on Filling Lines & Enable the Delivery of Sensitive Vaccines & Biotech Drugs
Sebastien Cordier, Laure-Hélène Guillemot, PhD, and Audrey Chardonnet explain how the PremiumCoat 1-3-mL syringe plunger combines a pure Bromobutyl formulation with a market-proven ETFE film that acts as a barrier to limit the transfer of rubber leachables into the drug product.
EXECUTIVE INTERVIEW – Emergent CDMO: Making the Impossible, Possible for Biopharma Innovators
Catherine Hanley, Vice President & Interim CDMO Business Unit Head at Emergent BioSolutions, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
HUMAN FACTORS STUDIES – Human Factors Studies During a Pandemic: How One Company Adapted to Covid-19 Restrictions
Miranda Newbery says although it is possible to carry out use risk assessments, expert reviews and device comparisons – which do not require contact with end users – these cannot fully replace first-hand user feedback.
ARTIFICIAL INTELLIGENCE – Attempting to Speed Up Vaccine Development to Combat the Next Pandemic
Lars Wegner, MD, in the wake of the huge impact Covid-19 has had around the world, presents a state-of-the-art mathematical modelling and algorithms approach to vaccine development to prevent the next pandemic.
EXECUTIVE INTERVIEW – Croda: Solutions for Your High Value Drug Products
Dr. Stephen Rumbelow, Life Sciences Research Fellow for Croda Inc., discusses polysorbates, a key excipient used for stabilizing drug molecules in injectable dosage forms.
CONNECTED DELIVERY – Five Perspectives on Connected Drug Delivery Devices
George I’ons offers insight into the factors driving the development and adoption of connected drug delivery devices and examines the varying perspectives held by relevant healthcare stakeholders.
DRUG DEVELOPMENT – Simplifying the Drug Development Journey
Fran DeGrazio explains how experienced and focused collaborators can provide guidance, support services, manpower, and intellect to make it easier to achieve all the goals needed in delivering a drug to a patient.
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.
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.
EXCLUSIVE WEBINARS
WEBINAR – ILC Dover: Handling Potent Products in a Sterile Environment
The need for flexible solutions for potent product handling is increasing. We’ll discuss the proven benefits of aseptic isolator systems in sterile environments and take a look at real feedback from real customers of ours in an upcoming webinar on Tuesday, November 16th at 11:00 AM EST.
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….
EXCLUSIVE WHITEPAPERS
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…
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.
EXCLUSIVE ONLINE CONTENT
Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation
Revive Therapeutics Ltd. recently announced it has filed an application with the US FDA to receive Orphan Drug Designation (ODD) for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver….
Diffusion Pharmaceuticals Doses First Participants in Altitude Trial
Diffusion Pharmaceuticals Inc. recently announced it has dosed the first participants in its Altitude Trial. The trial will evaluate the company’s lead product candidate, trans sodium crocetinate (TSC)….
Decibel Therapeutics Announces Extension of Research Term Under Strategic Collaboration With Regeneron to Discover & Develop Gene Therapies for Hearing Loss
Decibel Therapeutics recently announced that Regeneron has extended the research term of its collaboration with the company to discover and develop gene therapies for hearing loss…..
Cytovia & Cellectis Expand Their TALEN Gene-Edited iNK Partnership to Enable Broader Collaboration in China
Cytovia Therapeutics, Inc. and Cellectis recently announced they have expanded their collaboration of TALEN gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and….
ImmunityBio Expands Vaccine Program to Accelerate Use of “Mix-and-Match” Technologies in Developing & Manufacturing Next-Generation COVID-19 Vaccines
ImmunityBio, Inc. recently announced the expansion of the company’s cancer and infectious disease vaccine programs to include self-amplifying self-adjuvating RNA (SASA-RNA), recombinant protein vaccine candidates, and potent adjuvant formulations that….
Artizan Biosciences & Biohaven Therapeutics Announce Therapeutic Development Program in Parkinson’s Disease
Artizan Biosciences, Inc. and Biohaven Therapeutics Ltd. recently announced the companies are initiating a therapeutic discovery and development program in Parkinson’s disease (PD), to exploit recent….
Sever Pharma Solutions Acquires Foster Delivery Science
Sever Pharma Solutions (SPS) recently announced it has entered into a definitive agreement to acquire the assets of Foster Delivery Science (FDS) located in Putnam, CT…..
Arranta Bio Announces Completion of Sale of Florida Site & Progress on $150-Million Investment Plan to Expand Development & Commercial Manufacturing Services
Arranta Bio recently announced the completion of the sale of its process development and GMP clinical manufacturing site in Gainesville, FL, to Inceptor Bio and the transfer of client programs and key….
SOTIO Expands Its Antibody-Drug Conjugate Pipeline With Exclusive Collaboration & License Agreement With LegoChem Biosciences
SOTIO Biotech recently announced an exclusive, target-specific license and option agreement with LegoChem Biosciences Inc in which SOTIO will obtain rights to deploy LCB’s ADC technology for up to….
Kala Pharmaceuticals Acquires Combangio, Expanding its Pipeline With a Clinical-Stage Novel Biologic for the Treatment of Persistent Corneal Epithelial Defect (PCED) & Other Rare Ocular Surface Diseases
Kala Pharmaceuticals, Inc. recently announced it has acquired Combangio, Inc., a private, clinical-stage company developing regenerative biotherapies for severe ocular surface diseases…..
