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.
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.
NASAL DRUG DELIVERY - Overcoming the Challenges of Formulation Development
Eric Kaneps explores the nasal drug delivery landscape, including the benefits of nasal administration compared with other routes and the unique formulation challenges associated with this delivery method.
EXECUTIVE INTERVIEW - Salipro Biotech & Bio-Rad Laboratories: A Powerful Solution for Antibody Discovery Against Challenging Transmembrane Targets
Dr. Jens Frauenfeld, CEO, Salipro Biotech, and Dr. Francisco Ylera, R&D Team Lead at Bio-Rad Laboratories, explain how their collaboration is leveraging the Salipro® platform alongside Bio-Rad’s Pioneer™ Antibody Discovery Platform to target transmembrane proteins.
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……
Have expert content to share? Contact us
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
Trethera Secures New License, Strengthening TRE-515 Intellectual Property Portfolio & Extending Market Exclusivity to 2045
Trethera Corporation recently announced it entered an exclusive, worldwide licensing agreement with the University of California, Los Angeles (UCLA). The license expands Trethera’s intellectual property…
Rilzabrutinib Granted Orphan Drug Designation in the US for Sickle Cell Disease
The US FDA has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that works via multi-immune modulation,…
Medicines Discovery Catapult & the Francis Crick Institute Partner to Support KQ Labs, a Leading Accelerator for Life Sciences Innovators
Medicines Discovery Catapult (MDC) and the Francis Crick Institute are pleased to announce a new strategic partnership to support the delivery of KQ Labs, a…
Symeres & Yoneda Labs Use AI to Optimize Cross-Coupling Reactions
Yoneda Labs, a leader in computational tools for reaction optimization, has successfully collaborated with Symeres, a leading transatlantic, small molecule contract research and manufacturing organization.…
Coya Therapeutics Announces Issuance of New Patent Protecting Methods of Producing Recombinant Human Interleukin-2 Liquid Formulations
Coya Therapeutics, Inc. recently announced the issuance of a US patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. In particular, the US…
Fujifilm Rebrands Life Sciences Companies to Strengthen Position as Strategic Partners for Life, Offering End-to-End Solutions
FUJIFILM Corporation's Life Sciences Group companies, a portfolio of businesses offering products, services and comprehensive solutions that span all stages of therapeutic development from discovery…
Kymera Therapeutics Announces Positive First-in-Human Results From Phase 1 Trial of a First-in-Class, Oral STAT6 Degrader
Kymera Therapeutics, Inc. recently announced positive clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class, oral STAT6 degrader medicine. “Our primary objective…
CAR-T Therapies Need to Overcome Current Limitations to Unlock Promising Treatment Possibilities for Solid Tumors
CAR-Ts are revolutionizing the treatment of blood cancers, such as B-cell acute lymphocytic leukemia. However, their success has not yet extended to the realm of…
Curevo Enrolls First Participants in Phase 2 Extension Trial
Curevo Vaccine recently announced the enrollment of the first patients in a Phase 2 extension trial of its investigational shingles vaccine, amezosvatein. “I’m so proud…
BioNTech & Bristol Myers Squibb Announce Global Strategic Partnership to Co-Develop & Co-Commercialize Next-Generation Bispecific Antibody Candidate Broadly for Multiple Solid Tumor Types
BioNTech SE and Bristol Myers Squibb recently announced they have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody…
CERo Therapeutics Doses First Patient With CER-1236 in Phase 1 Clinical Trial for Acute Myeloid Leukemia and is Advancing Through Protocol-Defined Evaluations
CERo Therapeutics Holdings, Inc. recently announced it has dosed the first patient in its Phase 1 clinical trial of CER-1236. The patient was dosed at…
Cellares & Mitsui Fudosan Announce the First IDMO Smart Factory for Commercial-Scale Cell Therapy Manufacturing in Japan
Cellares, in collaboration with Mitsui Fudosan, recently announced the establishment of Japan’s first next-gen commercial production site for CAR-T cell therapies. The facility is under…
Sibeprenlimab's Priority Review Highlights Potential to Differentiate in IgAN Space
Otsuka Pharmaceutical recently announced that the FDA has accepted for review the Biologics License Application (BLA) for sibeprenlimab, which acts as A Proliferation Inducing Ligand…
Cartesian Therapeutics Announces First Participant Enrolled in the Phase 3 Trial of Descartes-08 in Patients With Myasthenia Gravis
Cartesian Therapeutics, Inc. recently announced the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).…
Bora Adds Automated Fill/Finish Line in Baltimore
Bora Pharmaceuticals Co., Ltd. recently announced that due to continued growth in demand for its drug product services, it plans to add further sterile fill/finish…
Nuclera & Cytiva Collaborate to Accelerate Characterization of Proteins for Drug Development
Nuclera recently announced a collaboration with Cytiva focused on accelerating the production, purification, and characterization of proteins required for drug research and development, enabled through…
Alvotech & Advanz Pharma Extend Strategic Partnership to Commercialize Three Additional Biosimilars in Europe
Alvotech and Advanz Pharma recently announced they have entered an agreement to expand their commercial partnership to cover three additional biosimilar candidates. The new agreement…
Candel Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for CAN-2409 for the Treatment of Prostate Cancer
Candel Therapeutics, Inc. recently announced the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the company’s biological immunotherapy lead…
Monarch Therapeutics & SNAP Biosciences Enter Licensing Agreement to Bolster Cell Therapy in Oncology
SNAP Biosciences, Inc., a majority-owned subsidiary of Coeptis Therapeutics Holdings Inc., and Monarch Therapeutics Inc. recently announced a licensing agreement to enable the development and…
ProMed Pharma Secures DEA Registration for Schedule III Controlled Substances
ProMed Pharma recently announced it has successfully secured registration from the U.S. Drug Enforcement Administration (DEA) to handle Schedule III controlled substances. This regulatory milestone…
