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.
EXECUTIVE INTERVIEW - Plus Therapeutics: Advanced Drug Delivery Solutions
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:….
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EXCLUSIVE WHITEPAPERS
WHITEPAPER - OXYCAPT™: Multilayer Plastic Vial: An Optimal Primary Container for Drug Products Transported With Dry Ice
OXYCAPT™ vial is the multilayer primary container with the distinctive structure that includes the gas barrier layer in the middle layer. They offer optimal features for the transport and storage of advanced therapeutics, such as cell and gene therapy products.
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…
EXCLUSIVE WEBINARS
WEBINAR - 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
Terumo Announces Commercial Launch of the Immucise Intradermal Injection System
Terumo Corporation (TSE: 4543) recently announced the commercial launch of its Immucise™ Intradermal Injection System, which is designed to deliver vaccines and other approved drugs…
Sanofi Completes Acquisition of Blueprint Medicines
Sanofi recently announced the completion of its acquisition of Blueprint Medicines Corporation, adding to its portfolio a commercialized medicine, a promising pipeline, and the expertise…
Lexicon Announces Patient-Reported Data on Diabetic Peripheral Neuropathic Pain
Lexicon Pharmaceuticals, Inc. recently announced data from a study of patients describing the impact of diabetic peripheral neuropathic pain (DPNP) despite treatment with standard of…
Lisata Therapeutics & WARPNINE Announce iLSTA Trial Enrollment Completion & Provide Preliminary Data Update
Lisata Therapeutics, Inc. and WARPNINE Incorporated recently announced the successful completion of patient enrollment in the Phase 1b/2a iLSTA trial (ACTRN12623000223639) in Australia. The study…
Gelteq Announces Agreement With IDT Australia to Secure Dedicated New Product Development & Manufacturing Facilities
Gelteq Limited recently announced it has entered into a memorandum of understanding with IDT Australia (ASX: IDT) for a dedicated, locally based manufacturing facility to…
Genascence Announces FDA Grants Regenerative Medicine Advanced Therapy Designation to GNSC-001 for Knee Osteoarthritis
Genascence Corporation recently announced the US FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to GNSC-001, a potential first-in-class gene therapy blocking interleukin…
Quetzal Therapeutics Debuts With Expert Leadership, High-Impact Pipeline & $50 Million of Committed Capital
Quetzal Therapeutics, a newly formed biopharmaceutical company, announced its official launch today with $50 million of committed capital. Founded to address urgent unmet needs in…
Cereno Scientific Announces Positive Topline Results From Phase 1 Trial of a Novel HDAC Inhibitor Supporting Advancement Into Phase 2
Cereno Scientific recently announced positive topline results from its Phase 1 trial of CS014, a novel HDAC inhibitor in development for idiopathic pulmonary fibrosis (IPF).…
Safi Biotherapeutics & Functional Fluidics Initiate Collaboration to Validate Health & Quality of Manufactured RBCs
Safi Biotherapeutics and Functional Fluidics recently announced a collaboration focused on validating the health and quality of Safi’s mRBCs to enable Safi to prepare a…
Amphista Therapeutics Announces Research Milestone in its Collaboration With Merck Triggering Milestone Payment
Amphista Therapeutics recently announced the successful achievement of a discovery research milestone under its exclusive research collaboration and license agreement with Merck. In conjunction with…
Oragenics, Announces US-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development
Oragenics, Inc. rrecently announced it has entered into a manufacturing agreement with Sterling Pharma Solutions, an industry leading CDMO with multiple US-based development and manufacturing…
Waters & BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science & Diagnostics Leader Focused on Regulated, High-Volume Testing
Waters Corporation and BD (Becton, Dickinson and Company) recently announced a definitive agreement to combine BD's Biosciences & Diagnostic Solutions business with Waters, creating an…
Biocon Biologics Expands Diabetes Portfolio With FDA Approval of the First & Only Interchangeable Rapid-Acting Insulin Aspart in the US
Biocon Biologics Ltd (BBL) recently announced the US FDA has approved Kirsty (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog…
Acumen Pharmaceuticals & JCR Pharmaceuticals Enter Strategic Collaboration, Option & License Agreement to Develop Enhanced Brain Delivery Therapy for Alzheimer’s Disease
Acumen Pharmaceuticals, Inc. recently announced a collaboration, option, and license agreement with JCR Pharmaceuticals to develop an oligomer-targeted Enhanced Brain Delivery (EBD) therapy for Alzheimer’s…
Sharp's Emissions Reduction Targets Validated by Science-Based Targets Initiative
Sharp, a leader in pharmaceutical packaging, clinical trial supply services and small-scale sterile manufacturing announced today that its near-term and long-term greenhouse gas (GHG) emission…
BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer
BriaCell Therapeutics Corp. recently announced the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612)…
Evestia Clinical to Merge With Atlantic Research Group
Evestia Clinical has merged with Atlantic Research Group to create a leading independent global specialist CRO group in fast-growing markets. The merger expands Evestia Clinical’s…
AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset Into Phase 1/2 Clinical Trial
AAVantgarde Bio recently announced the US FDA has cleared its Investigational New Drug (IND) application for AAVB-039, the company’s gene therapy program for Stargardt disease.…
Lisata Therapeutics Expands Intellectual Property Portfolio With New Composition of Matter Patent for Certepetide
Lisata Therapeutics, Inc. recently announced the United States Patent and Trademark Office (USPTO) issued the company a new composition of matter patent for certepetide through…
PolyPid Unveils a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Diabetes & Weight Loss Market
PolyPid Ltd. recently unveiled its long-acting GLP-1 receptor agonists (glucagon-like peptide-1 RA) delivery platform that aims to subcutaneously release GLP-1 RA for approximately 60 days,…
