Formulation Development
FORMULATION FORUM – Oral Formulation Approaches for Different Stages of Clinical Studies
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
EXECUTIVE INTERVIEW – Syner-G BioPharma: A Track Record of CMC Excellence
Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.
PLATFORM TECHNOLOGY – Predictive Medicine, Biomarkers & the Multiple Unmet Needs in Acute Respiratory Distress Syndrome
Joe G.N. Garcia, MD, and Stan Miele believe the unmet need in ARDS is to identify reliable, validated ARDS biomarkers that minimize ARDS heterogeneity and allow for stratification of subject selection for enrollment in clinical trials of tailored therapies. Combined with a more streamlined drug-approval process, biomarker- and genotype-based treatment of specific ARDS endotypes has never been as within reach as it is today.
BATCH RELEASE – The Business Case for Reinventing Batch Release
Aparna Seksaria reviews how for pharmaceutical companies — and pharma supply chains — to bring safe, commercial-ready products to market quickly and profitably, and for them to meet growing demand for highly personalized, batch-size-one types of products, it’s critical that they take steps to de-risk and speed up processes like batch release, and do so without compromising quality, safety or the bottom line.
PERMEABILITY STUDIES – Onion Epithelial Membrane as a Model for Predicting Intestinal Absorption of Drugs
Antoine Al-Achi, PhD, Mounika Nangineedi, MS, Chaitali Koli, MS, et al, study 19 drugs with varying partition coefficient, water solubility, and molecular weight values to compare their diffusion through the middle epithelial membrane of onion with that of their Caco-2 cell line.
On-Demand Webinar: How to Safely Handle Your Antibody Drug Conjugate
Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications…..
WHITE PAPER: Tackling a Changing Climate; Metered Dose Inhalers | Recipharm
Are you prepared for the HFA phasedown? With many industries switching to more environmentally friendly propellants, pMDI developers need to be ready. Recipharm explore alternative…
SPECIAL FEATURE – Solubility & Bioavailability: Utilizing Enabling Technologies
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
DRUG DEVELOPMENT – The Promise of Cutting-Edge Microbiome-Based Therapeutics
Andrew Thomson, Brian Carpenter, and Robert Broadnax focus on how developers must strategically address and overcome specific challenges to successfully drive development and eventual adoption of microbiome-based therapies.
NASAL DELIVERY – Improving Nasal Drug Delivery With Permeation Enhancing Technology
Stuart Madden, PhD, focuses on the use of alkylsaccharides as absorption enhancers for nasal delivery of a wide range of drug types.
EXCLUSIVE ONLINE CONTENT
Catalent to Acquire Metrics Contract Services for $475 Million
Catalent, Inc. recently announced it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in….
Valneva & Pfizer Initiate Phase 3 Study of Lyme Disease Vaccine Candidate
Valneva SE and Pfizer recently announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and….
Rigel Pharmaceuticals & Forma Therapeutics Announce Licensing Agreement for Novel Mutant IDH1 Inhibitor
Rigel Pharmaceuticals, Inc. and Forma Therapeutics, Inc. recently announced they have entered into an exclusive, worldwide license agreement to develop, manufacture, and commercialize….
PolyPid Announces Exclusive Licensing Agreement With Advanz Pharma
PolyPid Ltd. recently announced it has entered into an exclusive licensing agreement with ADVANZ PHARMA Corp. for the commercialization of its lead drug candidate, D-PLEX100 for the prevention of….
New Lipid Facility at Evonik’s Site in Hanau to Produce Clinical & Launch Quantities of Lipids for Innovative Medicines
Evonik is building a new cGMP facility to manufacture lipids for clinical development and launch of innovative medicines. The new cGMP lipid launch facility is located in….
MARKET NEWS & TRENDS
WEBINARS
WEBINAR – Hot-Melt Granulation Technology for Lipid-Based Pharmaceuticals
Join our experts Dr. Mandar Kodgule, Dr. Rahul Aware, and Dr. Agnivesh Shrivastava live as they take you through compelling case studies, current trends and developments, and insights on mastering the design of hot-melt granulation process.
ON-DEMAND WEBINAR – Exploring Pectin & the Advancement of Delayed Release Technology
In this webinar, experts will provide an overview of why the properties and structure of pectin are well suited for site-specific delivery to the colon. In addition, experts will also provide insights into how softgel capsules, formed by the combination of both pectin and gelatin, are used in OptiGel® DR, a new delayed release delivery technology for pharmaceutical applications.
WEBINAR – Understanding Patch Composition for Effective Transdermal Delivery
As the advantages of transdermal drug delivery grow, the global market for transdermal patches also is growing. Join DuPont™ Liveo™ Healthcare Solutions and Gattefossé Pharmaceuticals for a complimentary one-hour webinar to explore the current….
On-Demand Webinar: How to Safely Handle Your Antibody Drug Conjugate
Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications…..
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.
WHITE PAPERS
WHITEPAPER – Antibody-Based Drug Discovery at the Speed of Light
Learn how the combination of the PentaMice® platform and single B cell screening with the Berkeley Lights Beacon® Optofluidic system increases speed to market for monoclonal antibody therapeutics….
WHITEPAPER – Protecting Workers and the Environment: Facilities and Processes Key to Safely Making Highly Potent Drug Products
Handling HPAPI drug products requires skill, expertise and knowledge of safety considerations. This whitepaper examines the importance of US based drug product manufacturing and facility requirements to safely and efficiently manufacture solid oral dosage (SOD) HPAPI products….
WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….
WHITE PAPER – Nanoparticles in Drug Delivery & Photothermal Therapies
Download this white paper to learn more about the applications of silica and metal-based nanoparticles in drug delivery and photothermal therapy…..
WHITEPAPER: Optimizing Oral Drug Delivery Using Zydis® Orally Disintegrating Tablet Technology to Address Patient Challenges
Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments…