SPECIAL FEATURE- Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure
Contributor Cindy H. Dubin speaks with many CDMO professionals to get their insights and perspectives on the current state of the industry.
FORMULATION FORUM - Manufacturing of Solid Oral Dosage Forms by Direct Compression
Jim Huang, PhD, and Shaukat Ali, PhD, say not all excipients are well suited for DC, so challenges remain to find excipients compatible to DC due to certain physicochemical properties associated with poor flowability, lack of plasticity, flexibility, and compressibility.
ESG STRATEGY - Sustainable Foundations: Embedding ESG Principles at Every Level
Benedicta A. Bakpa, MSc, says a robust environmental, social, and governance (ESG) strategy is increasingly important for businesses to align with stakeholder values.
OUTSOURCING - The Power of Partnerships Fueling Biopharma Progress With Advanced Tools & Expert Support
Lisa V. Sellers, PhD, says as biopharma moves faster and new drug approvals reach an all-time high, relationships with critical component suppliers and expert development and manufacturing partners cannot be an afterthought.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: Fast, Flexible, and Focused: The Secrets of a Successful CDMO Partnership
Steven Facer, Senior Vice President of Sales and Marketing at Adare Pharma Solutions, shares practical insights on what makes CDMO partnerships work and what can cause them to fall short.
PROTEIN BARCODING - Streamlining mRNA Therapeutic & Vaccine Development
Meredith Carpenter, PhD, reviews how lipid nanoparticles have emerged as a powerful tool for delivery due to their low immunogenicity compared to viral vectors, along with their ability to encapsulate and protect nucleic acids and facilitate their entry into cells.
EXECUTIVE INTERVIEW - Sanner Group: Building a Suite of World-Leading Services for its Customers
Chris Gilmor, Vice President of Sales, Sanner of America, explains how Sanner’s Advance with Agility™ program helps its partners achieve faster development times and reduce time to market, and how the company embeds sustainable practices into its global business.
DRUG ADMINISTRATION - Protecting Patient Data in Cell & Gene Therapy: The Role of Tech Platforms
Matthew Lakelin, PhD, explores the unique data challenges in CGT, emphasizing the need for robust technology platforms to ensure patient privacy and security.
FACILITY DESIGN - Holistic Facility Design in Injectable Fill-Finish Operations
Chad Hafer believes companies need to consider a more comprehensive approach that not only ensures compliance but also incorporates cutting-edge technologies and prioritizes sustainability.
CLINICAL TRIALS - Solving Clinical Trial Challenges Through Sub-Population Optimization & Modeling Solution
Adrian Kizewski, MSc, MBA, says in recent years, a revolutionary approach known as Sub-population Optimization & Modeling Solution has emerged to transform the landscape of clinical trials and offer new hope for more efficient and successful studies.
SPECIAL FEATURE - PFS & Parenteral Delivery: Innovation Is Focused on Patient-Centric, Smart & Sustainable Solutions
Contributor Cindy H. Dubin speaks with several innovating companies to discuss trends in PFS as well as advancements in autoinjectors and innovations in parenteral delivery.
TRANSDERMAL DELIVERY - SkinJect’s Doxorubicin-Loaded Dissolvable Microneedle Array (D-MNA): A Revolutionary Approach to Transdermal Drug Delivery
Raza Bokhari, MD, Edward Brennan, MD, FACS, and Madison Weisz, MS, explore the D-MNA treatment, highlighting its drug delivery mechanisms, advantages over traditional treatments, and clinical potential.
EXECUTIVE INTERVIEW - PCI Pharma Services: Driving Precision, Agility & Partnership in Complex Drug Development
Anshul Gupte, PhD, RAC Drugs, VP of Pharmaceutical Development at PCI Pharma Services, talks about phase-appropriate development, technical hurdles in pharmaceutical sciences, building agile teams, and what sponsors should prioritize when planning their strategy for novel therapies.
FORMULATION FORUM - Self-Emulsifying Drug Delivery Systems for Improving Oral Bioavailability of Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say as more NCEs continue to be discovered with less options to find the appropriate excipients and solubilizers for Class II and IV drugs, the pharma industry has begun to evaluate liquid SEDDS for expediting drugs to market.
EXECUTIVE INTERVIEW - Botanical Solution Inc.: Launching a Revolution in Economical & Environmentally Sustainable QS-21 Vaccine Adjuvant Production
Gastón Salinas, CEO of Botanical Solution Inc., discusses his company’s transition from agriculture to pharmaceuticals, addressing the global shortage of QS-21, and developing the QS-21 gold standard vaccine.
EXPERT CONTENT & RESOURCES
Whether you're a researcher, a pharmaceutical professional, or simply interested in the latest advancements in drug development and delivery technology, you'll find a wealth of insightful expertise and current resources here.
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……
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EXCLUSIVE WHITEPAPERS
WHITEPAPER - Container Selection for a Highly Sensitive Drug Product: A Success Story
When Stevanato Group is involved from the early stages, before the container is even chosen, we can support the client with a comprehensive data-driven analysis so the client can make an informed choice and select the optimal solution for their drug product.
WHITEPAPER: Partnering With Gattefossé to Tackle Veterinary Medicine Challenges
Veterinary medicines face unique challenges due to species diversity, physiology, and dosing needs. Animals can’t be instructed to take medicine, so palatability, safety, and bioavailability are key.
WHITEPAPER - 3D SCREEN Printing: Enabling a New Generation of Complex Formulations
By overcoming key challenges 3D screen printing is unlocking new possibilities in drug development and manufacturing.
WHITEPAPER - Formulating Custom Viscosity Blends With POLYOX™ Polyethylene Oxide
Excipient variability plays a critical role in pharmaceutical product design. A risk-based, scientific approach to Quality by Design (QbD) is essential to ensure consistent drug…
CASE STUDY - Overcoming Barriers to Patient Adherence With A Novel Dosage Form
In this CPHI Award-winning case study, learn how Adare scientists took the alternative sprinkle version out of the lab and into the hands of patients.
EXCLUSIVE WEBINARS
WEBINAR ON DEMAND: Precision at Scale: Enabling Novel Therapeutics With Nanoparticle Manufacturing
Watch this on-demand webinar to learn about the key steps and considerations in bringing novel nanoparticle-based therapeutics from early R&D to commercial stages. Drawing from our 20 years of experience in the CDMO space, we cover critical topics unique to nanomaterials…..
WEBINAR: Introducing Key Concepts in Tableting Research: Unleashing Essential Concepts and Strategies for Enhanced Formulation Development
Tableting can present a series of challenges, particularly when dealing with formulations that have poor flowability, low compressibility, or high cohesivity. These issues can lead to manufacturing inefficiencies….
WEBINAR ON DEMAND: Advantages of Carbopol® Polymers in Oral Formulations
In this video, the Lubrizol team together with the IMCD US team takes you through formulation aspects of Carbopol® polymers as well as the results of a case study on an Acetaminophen oral suspension formulation.
WEBINAR - ABISOL Emulsion Preconcentrate Kit & ABISORB-DC Excipient System for Tableting Lipids
ABITEC Technical Business Director, John Tillotson, RPh, PhD, discusses ABITEC’s latest products: The ABISOL Emulsion Preconcentrate kit for the easy formulation of emulsified drug delivery systems and the….
WEBINAR - Development of Orally Delivered GLP-1 Therapeutics…From Diabetes to Obesity and Beyond
Join Quotient Sciences’ experts on July 18 as we explore the latest developments in orally-delivered GLP-1 agonists, the potential for these therapeutics and overcoming the manufacturing challenges.
MARKET NEWS & TRENDS
BriaCell Announces Positive Recommendation from Data Safety Monitoring Board for Pivotal Phase 3 Study in Metastatic Breast Cancer
Independent DSMB identifies no safety concerns, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor Review marks…
Longeveron Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months Laromestrocel Biological License Application (BLA) submission for…
Neurona Doses First Patient in Phase 1/2 Trial of NRTX-1001 Cell Therapy in Adults with Drug-Resistant, Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
- First patient received bilateral administration of NRTX-1001; no significant surgical complications or adverse events reported to date - - Trial funded by a…
BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America
New Good Manufacturing Practice (GMP) Solution Center in Wyandotte, Michigan expands BASF’s existing network of poloxamers sites Production capabilities are unique to industry and enable…
Veranova Devens Site Breaks Ground on ADC Facility Expansion
Devens, MA, USA — Government officials, industry leaders, and local business representatives gathered yesterday to mark the groundbreaking of Veranova’s latest expansion at its Devens,…
Symbiotic.blue Launches to Combine Oxford and Cambridge Scientific Brain Power with Bioentrepreneurial Leadership to Reinvent AI Drug Discovery
Symbiotic.blue, the UK’s newest Techbio company has launched to innovate a next-generation artificial intelligence-driven drug discovery (AIDD) platform by combining the power of generative AI…
Synfini Inc. and O2nix Bio Announce Strategic Collaboration to Develop Novel Cancer Therapeutics Targeting FTSJ1
MENLO PARK, Calif. and CAMBRIDGE, Mass.,Synfini Inc., a leader in AI-driven drug discovery, and O2nix Bio, a pioneering biotech company advancing prooxidant therapies, today announced…
Sanner has officially launched manufacturing operations in Greensboro, North Carolina
The new facility is dedicated to producing critical injection-molded components for medical devices and pharmaceutical packaging, as well as desiccant solutions. This expansion reflects Sanner’s…
Kindeva joins forces with Rocket Science Health to pioneer new Intranasal Delivery Platform
Kindeva, a global CDMO and drug delivery expert, and Rocket Science Health (RSH), a Canadian technology healthcare company, have joined forces to find partners to…
Lifecore Biomedical Signs New 10-Year Commercial Manufacturing and Supply Agreement with Key Existing Custome
CHASKA, Minn., Lifecore Biomedical, Inc., a fully integrated contract development and manufacturing organization (“CDMO”), today announced that it has signed a new 10-year commercial manufacturing…
Northstrive Biosciences Announces Initiation of Phase II of Collaboration to Develop AI Powered Therapies for Obesity and Cardiometabolic Disease
Northstrive Biosciences and Yuva Biosciences previously announced a collaboration leveraging MitoNova™, YuvaBio’s proprietary mitochondrial science-focused artificial intelligence platform, to discover and develop novel pharmaceutical treatments for obesity, type 2 diabetes and other cardiometabolic conditions.
Captain T Cell Joins Bayer Co.Lab Berlin to Accelerate Autologous and Allogeneic TCR-T Cell Therapy Programs for Cancer Patients
Captain T Cell a biotech company developing next-generation TCR-based cell therapies for patients with solid tumors, today announced that it has been selected for residency…
Tiziana Life Sciences Expands Phase 2 Clinical Trial of Intranasal Foralumab With Commencement of First Patient Dosing
Tiziana Life Sciences, Ltd recently announces that dosing has commenced at the prestigious Weill Cornell Medicine Multiple Sclerosis Center in New York City, in its ongoing…
Abbott & Medtronic Pest Positioned Manufacturers in US Neurology Market
As US tariff policies evolve in 2025, neurology device manufacturers face rising cost pressures and growing uncertainty over production strategy. However, Abbott and Medtronic are…
BioNTech Announces Strategic Transaction to Acquire CureVac
BioNTech SE and CureVac N.V. recently announced they have entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares…
Aragen Biomanufacturing Site Completes Qualification With First GMP Batches in July 2025
Aragen recently announced it will commence GMP manufacturing at its biologics manufacturing facility in Bangalore, India, from July 2025. Aragen has successfully completed the facility…
Ethris & Thermo Fisher Parther to Enhance Access to mRNA Technology
Ethris GmbH recently announced a strategic collaboration with Thermo Fisher Scientific to provide a fully integrated mRNA solution to biopharmaceutical developers. The collaboration brings together…
Lifecore Biomedical Receives Accelerated Payment of Remaining $10 Million in Proceeds From Prior Equipment Sale
Lifecore Biomedical, Inc. recently announced it has received the remaining $10 million in proceeds from the previously disclosed sale of its excess high-speed, multi-purpose 10-head…
Vaxart Reports Positive Clinical Data Demonstrating its Second-Generation Vaccine Technology Produces Much Stronger Antibody Responses Than its First-Generation Technology
Vaxart, Inc. recently reported positive topline results from the Phase 1 clinical trial evaluating its second-generation oral pill norovirus vaccine constructs head-to-head against its first-generation…
Nicoya Acquires Applied Photophysics, Expanding Biologics Characterization Capabilities for Faster Time-to-Clinic & Reduced Late-Stage Failures
Nicoya Lifesciences, Inc. recently announced its acquisition of Applied Photophysics, bringing a 50-year history of delivering established analytical methods and reliable instrumentation, which will now…
