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
Vytal: The RTU snap-fit system for container closure solutions – Setting the standard for the future.
In recent decades, the landscape of parenteral drug production has undergone significant transformation, driven by the emergence of novel molecules and advanced therapies. The pharmaceutical…
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….
MARKET NEWS & TRENDS
Aenova expands cold chain capabilities with new state-of-the-art warehouse at its sterile site in Latina
Latina (Italy), Aenova, a leading global contract development and manufacturing organization (CDMO), is investing in a new cold chain warehouse at its sterile site in…
PharmNovo announces CTA submission for lead candidate PN6047, a next generation selective Delta Opioid Receptor Agonist (DORA) for treatment of neuropathic pain
PN6047 is a first-in-class small molecule that selectively activates the delta opioid receptor (DOR), avoiding interaction with the mu opioid receptor that is the basis…
Genenta Announces Long-Term Follow-Up Observations in Brain Tumor (GBM) Study with Emerging Survival Signals
Genitourinary Tumor Study Ongoing with Active Screening and Enrollment MILAN and NEW YORK, Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, today announced that a…
atai Life Sciences Announces $50 Million Private Placement Financing
Financing co-led by Ferring Ventures S.A. and Apeiron Investment Ltd. with participation from new and existing healthcare-focused institutional investors, including Ally Bridge Group and ADAR1…
Apellis to Receive up to $300 Million from Royalty Purchase Agreement with Sobi for Ex-U.S. Royalties of Aspaveli (systemic pegcetacoplan)
Apellis to receive $275 million upfront and up to $25 million in milestone payments upon EMA approval in C3G and IC-MPGN Non-dilutive financing further…
Aptamer Group Identifies Novel Target to Enable Cell-Specific Gene Therapy for Liver Fibrosis
Aptamer unveils novel biomarker for targeted liver fibrosis therapy Optimer breakthrough targets liver scarring cells, positioning Aptamer in $20bn fibrosis market Aptamer Group plc today…
Artelo Biosciences Announces Positive First-in-Human Data for ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain
First Orally Active Fatty Acid Binding Protein 5 Inhibitor Evaluated in Humans First-in-Class Approach Targets Unmet Need in Multibillion-Dollar Pain Management Market SOLANA BEACH, Calif.,…
Simtra BioPharma Solutions Expands Halle/Westfalen, Germany Facility with the Addition of a New Production Building
HALLE (WESTFALEN), Germany, Simtra BioPharma Solutions announced today that it completed the construction of its new production manufacturing building at its campus in Halle, Germany. As…
Vetter Marks the Start of New Clinical Site Construction with Groundbreaking Ceremony
Pharmaceutical service provider expands its footprint in the greater Chicago area Production site expected to be fully operational by the end of 2029 Modern site…
Allarity Therapeutics Announces Dosing of Second Patient in New Phase 2 Trial of Stenoparib in Advanced Ovarian Cancer
TARPON SPRINGS, Fla., Allarity Therapeutics, Inc. (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor…
Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
RESEARCH TRIANGLE PARK, N.C., Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and…
Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair (omalizumab)
REYKJAVIK, Iceland and PISCATAWAY, N.J. and LONDON, Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients…
Sever Pharma Solutions Announces Commercialization of New Aseptic Fill and Finish Line for Prefilled Syringes in Malmö, Sweden
MALMÖ, SWEDEN– Sever Pharma Solutions, a leading CDMO, proudly announces the commercialization of its new state-of-the-art aseptic fill and finish line for prefilled syringes, capable…
Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer
HOUSTON, Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced…
Priothera Secures €1.7 million i-Nov Funding by Bpifrance for Rare Blood Cancer Clinical Program
Saint-Louis, France and Dublin, Ireland, Priothera, a late-stage biopharma company pioneering the development of mocravimod, a novel oral sphingosine 1 phosphate (S1P) receptor modulator, to treat…
Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company’s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease
BOSTON, Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for…
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…
