Expert Content & Resources
How Can a Stage-Based Program to Determine HME Applicability Benefit Your API?
Low bioavailability due to poor API solubility is one of the major challenges to be overcome when developing oral dosage form drug products. An effective way of addressing this problem is to transform low solubility APIs into amorphous solid dispersions (ASDs) and can often be achieved via hot melt extrusion (HME).
Nitrosamine Risk Assessment and Mitigation in Pharmaceutical Products
This paper explores practical approaches for identifying and mitigating nitrosamine risks in drug products, integrating emerging tools such as predictive machine learning, advanced nitrite testing methodologies, and strategic excipient sourcing.
CAPMUL GDO (Glycerol Dioleate) is a Versatile Excipient for Pharmaceutical Formulations
ABITEC is excited to present its latest excipient, CAPMUL GDO, Glycerol Dioleate. CAPMUL GDO is a high-purity, highly versatile functional lipid
The Benefits of Transparent Pricing: How to Compare CMO Proposals & Know What Your True Costs Will Be
We want your experience as a pharmaceutical professional responsible for evaluating and selecting a CMO to be different. This article will help you be prepared when choosing a CMO from among multiple candidates.
The Value of Expertise in Aseptic Fill Finish Manufacturing of Biologics
One way to mitigate the risk associated with aseptic fill finish manufacturing of biologics is to partner with a contract manufacturing organization (CMO) demonstrating proven expertise in all aspects of biologics production.
Closing the Access Gap in Pediatric Oncology & Why Neuroblastoma Families Are Still Struggling
Neuroblastoma is a rare pediatric solid tumor that arises from immature nerve cells. It accounts for roughly 15% of childhood cancer deaths, despite being only 6%-10% of diagnoses. Nearly half of children are diagnosed with…
Kindeva e-Book: A Bridge to the Future: Our World-Class Site in Bridgeton
In this e-Book, you will learn about, the integrated capabilities of Bridgeton, MO, which eliminate the risks of fragmentation, the breadth of projects that Kindeva can support, our continuous investment in the facility to ensure it meets today’s demands and the needs of tomorrow, and the benefits of partnering with Kindeva.
EXECUTIVE INTERVIEW - Plus Therapeutics: Advancing Targeted Radiotherapeutics for Rare & Difficult-to-Treat Cancers
Dr. Marc Hedrick, CEO of Plus Therapeutics, discusses the company’s targeted radiotherapeutic platform for central nervous system and solid tumor cancers and why internal radiation therapy offers patients a more advanced drug delivery solution compared to traditional external radiation therapy.
Exploring New Potential Through 505(b)(2)
When filing for a drug product approval via the 505(b)(2) regulatory pathway rather than a traditional development pathway, companies are afforded several advantages.
Ionizable Lipids in LNPs: A Selection Guide
Finding the right ionizable lipid is critical for optimal formulations. This guide helps navigate the wide range of ionizable lipids for specific therapeutic needs. Explore lipids by target or cargo type.
How to Choose the Right CDMO for Your Pharmaceutical Project
This guide outlines the fundamental considerations to ensure your CDMO selection aligns with your project goals.
Understanding the Foundation of LNP Formulation Success
Download our eBook and discover everything you need to know about lipids for developing LNP therapies, including:….
Lyophilization Development: Quality by Design Approach
Lyophilization, or freeze-drying, addresses stability challenges associated with complex APIs, biologics, microbiomes, gene therapies, viral vectors, liposomes, and nanoparticles……
Choosing the Right Particle for Your Nanomedicine Application
Nanoparticles are revolutionizing the landscape of nanomedicine, enabling significant advancements in early detection, targeted drug delivery, disease monitoring, and imaging. Due to their nanoscale size, these particles….
Join us for the inaugural Quotient Sciences Capability Expo, hosted at our state-of-the-art Garnet Valley facility.
This unique event offers a behind-the-scenes look at how we support molecules from preclinical stages through to commercial manufacturing…..
CLINICAL TRIALS - Need for Accessibility to Meet FDA Guidance for Decentralized Trials
Neil Vivian believes advances in electronic data collection and analysis are helping to make DCTs more accessible to broader and more diverse patient populations. Further innovations, particularly in artificial intelligence technology, are expected to accelerate these trends.
On-Demand Presentation: High Concentration Protein Suspensions: A Bevacizumab Case Study (>400 mg/mL)
Dr. Cindy Chung presents a case study demonstrating the development of high concentration bevacizumab suspension at up to 400 mg/mL for suitable subcutaneous delivery of the monoclonal antibody (mAb) therapy. Watch the presentation now to learn more.
DRUG-DEVICE DEVELOPMENT - Exploring the Complexities of Drug-Device Combination Products
Jeremy Guo, Senior Vice President at WuXi Biologics, and colleagues explain that many factors need to be taken into account when producing a Drug-Device Combination Product from development testing to fill/finish and assembly.
CPHI Annual Report 2024: Drug Delivery Trends & Insights From a Device Perspective
Significant growth in the drug delivery sector is predicted for many areas, with headliners including cell and gene therapies and the GLP-1 blockbusters. Small molecule-based formulations still dominate innovator pipelines, but advanced biologics are also….
Gelteq: A Breakthrough Ingestible Gel Drug & Nutrient Delivery System
Drug Development & Delivery recently interviewed Nathan Givoni, Co-Founder and CEO of Gelteq, to discuss challenges with traditional drug delivery and the company’s innovative ingestible gel platform designed for drug and nutrient delivery.
