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.
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.
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.
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.
Dr. Stephen Rumbelow, Life Sciences Research Fellow for Croda Inc., discusses polysorbates, a key excipient used for stabilizing drug molecules in injectable dosage forms.
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.
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.
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.
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.
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….
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….
Access our webinars on solubility strategies & pediatric drug development….
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…
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.
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.
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
Credence MedSystems, Inc. recently announced it has formed a strategic collaboration with Phillips-Medisize, a Molex company, a global leader in the design and manufacturing of solutions for the pharmaceutical drug delivery market…..
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…..
BD (Becton, Dickinson and Company) recently announced the launch of the BD SCF PremiumCoat Plunger Stopper in partnership with Aptar Pharma, a global leader in drug delivery solutions and services…..
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 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….
Agenus to Receive $20-Million Milestone Payment From Bristol Myers Squibb With Dosing of First Patient
Agenus Inc. recently announced it has triggered the first development milestone payment under its global licensing agreement with Bristol Myers Squibb for AGEN1777, an Fc-enhanced bispecific….
Metrics Contract Services, the US-based contract pharmaceutical development and manufacturing division of Mayne Pharma, recently announced the signing of a development and manufacturing agreement with….
MilliporeSigma Launches Excipient Technology Platform for Viscosity Reduction of Protein-Based Therapeutics
MilliporeSigma has recently launched a new Viscosity Reduction Excipient Platform to reduce the viscosity and help overcome manufacturing and formulation challenges associated with….