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……
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
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 industry has witnessed a notable shift towards biologics, mAbs, and cell-based therapies, which now represent some of the most successful pharmaceutical products globally.
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 its advanced technology portfolio with cutting-edge hot melt extrusion platform
Starnberg, Germany, Aenova, a leading global contract development and manufacturing organization (CDMO), relies on various innovative technologies to improve the oral bioavailability of poorly soluble…
Ofichem acquires Avivia B.V. to expand formulation development capabilities
Nijmegen, Netherlands, Ofichem Group has signed a definitive agreement to acquire Avivia B.V., a company specialized in formulation development based in Nijmegen, the Netherlands. The…
Alvotech Expands its Capacity in Assembly and Packaging with the Acquisition of Ivers-Lee in Switzerland
REYKJAVIK, Iceland and BURGDORF, Switzerland, Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today…
Bio-Rad Expands Droplet Digital PCR Offering Through Strategic Acquisition and Platform Rollout
HERCULES, Calif. Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, today announced the launch of…
Recursion Acquires Full Rights to REV102, a Potential First-in-Class Oral ENPP1 Inhibitor for Hypophosphatasia
Salt Lake City, UT, Recursion (NASDAQ: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives today announced the acquisition of Rallybio’s…
European Medicines Agency Grants Orphan Drug Designation to Spinogenix’s SPG601 for Treatment of Fragile X Syndrome (FXS)
LOS ANGELES, Calif., Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced that…
Certara Announces Expansion of Clinical Technology Collaboration with Merck
RADNOR, Pa., Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced a new collaboration with Merck, known as MSD outside of…
Medvantx Acquires RxS to Broaden Integrated Access & Engagement Solutions for Life Science
SAN DIEGO, Medvantx, a leading pharmacy services company, announced today that it acquired RxS, a leader in multichannel sample management and accountability solutions. The combined…
Artelo Biosciences Announces Positive Preclinical Efficacy with ART12.11 in Stress-Induced Depression Model
SOLANA BEACH, Calif., Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer,…
Chugai and Gero Enter into Joint Research and License Agreement to Develop Novel Therapies for Age-Related Diseases
TOKYO, Chugai Pharmaceutical Co., Ltd., and Gero PTE. LTD. , a Singapore-based biotechnology company, announced today that they have entered into a joint research and…
Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II)
SOUTH SAN FRANCISCO, Calif., Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics…
LENZ Therapeutics and Laboratoires Théa Announce Exclusive License and Commercialization Agreement for LNZ100 in Canada
SAN DIEGO and CLERMONT-FERRAND, France, LENZ Therapeutics, Inc. (Nasdaq: LENZ) and Laboratoires Théa (“Théa”) announced an exclusive license and commercialization agreement for Théa to register…
Oxford BioTherapeutics Announces Third Oncology Drug Candidate from Boehringer Ingelheim Collaboration Selected to Advance into IND-Enabling Studies
Oxford, UK and San Jose, California, Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and Antibody Drug Conjugate (ADC)-based therapies,…
Clearmind Medicine Announces IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Tel Aviv Sourasky Medical Center
Vancouver, Canada, Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major…
Upperton Pharma Solutions Wins Business Expansion Award at the 2025 Pharmaceutical Technology Excellence Awards
Nottingham, UK – Upperton Pharma Solutions, a leading Nottingham-based pharmaceutical contract development and manufacturing organization (CDMO), is delighted to announce its recognition as the winner…
Cue Biopharma Provides Update on Most Advanced Clinical Stage Asset, CUE-101
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…
Pelthos Therapeutics Completes Merger with Channel Therapeutics and Closes $50.1 Million Private Placement
DURHAM, N.C., Pelthos Therapeutics Inc., a biopharmaceutical company committed to commercializing innovative therapeutic products for high unmet patient needs, today announced the closing of the…
Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy
SAN DIEGO, - Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant…
Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy, ART-123 (Recomodulin, to enhance treatment options worldwide
Chelmsford, MA; Novi, MI; Düsseldorf, Germany; and Tokyo, Japan - Asahi Kasei Pharma has started trial drug administration in a Phase III study of ART-123…
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…
