Formulation Development
EXECUTIVE INTERVIEW - SK life science: Challenges of Developing Therapies for Neurological Diseases
Sebby Borriello, Vice President & Chief Commercial Officer, speaks about the challenges and trends surrounding development of therapies for neurological diseases.
FORMULATION FORUM - Formulation Research Strategy for Discovery-Stage New Drug Candidates
Jim Huang, PhD, and Edward Orton, PhD, say it is critically important CROs or CDMOs that support discovery and preclinical research have the requisite preformulation, formulation, and biopharmaceutics expertise as well as the proprietary methodologies to develop formulations from small quantities of drug candidates for different routes of administration.
CHARACTERIZATION CORNER - From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
FORMULATION FORUM - Sophisticated Formulation Approaches for Insoluble Drug Candidates
Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
TRANSLATIONAL PHARMACEUTICS - Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
EXTRACTABLES & LEACHABLES - A Practical Approach to Extractables & Leachables
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
TOPICAL DELIVERY - Novel Approaches to Topical Antibiotics Promise Innovation in the Treatment of Acne & Rosacea
Scott Herron, MD, PhD, indicates dermatologists and their patients need a better way to deliver antibiotics effectively without contributing to the resistance problem, and an ideal solution might be a new topical antibiotic formulation.
CLINICAL TRIALS - Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
HUMAN MICROBIOME - Advancing New Frontiers in a Rapidly Emerging Market
Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.
EXCLUSIVE ONLINE CONTENT
Abzena Launches Next-Generation Immunogenicity Tool for De-Risking the Development of Complex Biologics & Bioconjugates
Abzena recently announced the launch of its enhanced bioassay platform EpiScreen® 2.0, a comprehensive suite of assays that predict and evaluate potential risks of preclinical immunogenicity in protein….
Biolojic Design Announces Nektar Therapeutics Has Exercised its License Option to Develop an AI-Designed Agonistic Antibody Targeting TNFR2 for the Treatment of Autoimmune Diseases
Program is the Product of a Research Collaboration between Biolojic Design and Nektar entered in 2021….
Cellares & Bristol Myers Squibb Announce $380-M Worldwide Capacity Reservation & Supply Agreement
Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the US, EU, and Japan for Bristol Myers Squibb’s use ….
Neurolentech Signs Technology Access Partnership With Kaerus Bioscience
Kaerus Bioscience will access Neurolentech’s NDD Drug Discovery Platform to support development of its preclinical asset pipeline for numerous genetic syndromes….
Palisade Bio Enters Strategic Collaboration With Strand Life Sciences to Advance Precision Medicine Approach
Partnership marks a significant value-driving milestone in Palisade Bio’s mission to redefine UC treatment through targeted interventions based on PDE4-related biomarkers….
MARKET NEWS & TRENDS
WEBINARS
WEBINAR - 2024 Trends in Topical Drug Delivery: Insights & Innovation
This webinar will discuss some of the key trends from these leaders in the topical market on both a global and regional level, including the increased importance of sensory properties and the rise in non-conventional product formats, among others…..
WEBINAR - Enabling Upstream Intensified Bioprocessing
Intensified upstream bioprocesses are being developed to increase productivity while reducing footprint, costs, and timelines for manufacturing. The higher cell densities generated by….
WEBINAR - Nanoparticle Suspensions: History, Applications & CMC Aspects
This webinar describes the history, CMC aspects, and potential applications of nanoparticle suspensions (NSs). This drug delivery technology should be considered for crystalline, sparingly water-soluble APIs. The presentation highlights….
WEBINAR - Impact of Process Re-design on Sustainability in Pharmaceutical Small Molecule Manufacturing
Join us for an upcoming webinar that delves into a crucial issue in the pharmaceutical industry. Recent research has revealed a surprising fact: the pharmaceutical sector has a larger carbon footprint than even the automotive industry, especially when we consider the entire supply chain’s impact on
WEBINAR - Beyond the Lab: Unleashing the Potential of In Silico Modeling in Drug Product Formulation
In this webinar you will learn how digital chemistry tools facilitate rapid screening of formulation parameters, aiding in the identification of optimal drug delivery systems, excipient selection, and dosage forms….
WHITE PAPERS
WHITEPAPER - Manufacturing of 10-mg Loratadine Self-Emulsifying Drug Delivery System (SEDDS) Tablets by Direct Compression With ABISORB-DC & ABISOL Emulsion Preconcentrate Kit
10-mg loratadine SEDDS were successfully manufactured with ABISORB-DC(TM) and ABISOL(TM) 2 by direct compression on a rotary tablet press, employing standard pharmaceutical manufacturing equipment…..
WHITEPAPER - Revolutionizing Small Molecule API Production: Unveiling the Impact of Fermentation as a Sustainable Solution
While large molecules continue to advance in drug development pipelines, small molecule Active Pharmaceutical Ingredients (APIs) still retain their historical dominance among new drug applications…
WHITEPAPER - Copolymer Microstructures: Connecting Monomer Sequence Distribution With Biomedical End-Application Performance
To gain insights into advanced copolymer characterization techniques and their impact on drug release in biomedical products, we invite you to explore the latest Corbion white paper…..
WHITEPAPER - Monitoring Low Dose API Blend Uniformity With Parteck® M Mannitol Using Near-Infrared (NIR) Spectroscopy
Direct compression is often used for tablet manufacturing because it is the shortest, most effective, and least complex method. The physical properties of active pharmaceutical…
WHITEPAPER - The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation
This white paper evaluates the viscosity-reducing capacities of excipients and excipient combinations…..