2026 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
PURIFICATION STRATEGIES - Purification at Scale: Overcoming Chromatography Challenges for Advanced Modalities
William Sanders, PhD, explores the real-world challenges of scaling chromatography and highlights how contract development and manufacturing organizations (CDMOs) can help partners overcome them.
DRUG DEVELOPMENT - Common CMC Pitfalls in Orphan Drug Development
Hibreniguss Terefe, PhD, says although the unique challenges of orphan drug development are amplified by compressed timelines and limited patient populations, common pitfalls also serve as cautionary tales for other areas of drug development.
3D PRINTING - The Future of 3D Printing in Pharma: Aprecia’s Vision for Transformative Medicine
Kyle Smith, MBA, explains how his company, a pioneer in pharmaceutical 3D printing, has a vision for distributed, patient-centric manufacturing that could re-shape the future of medicine.
ORAL SUSPENSIONS - A New Standard in Oral Suspensions: Leveraging Novel Excipients for FDA Approval
Mary Schuster introduces a new approach to perfecting oral suspension formulations, which is centered on the strategic use of a “novel” synthetic functional excipient, magnesium aluminometasilicate (MAS).
DRUG DELIVERY - PharmaShell®: Enabling Once-Monthly Therapeutics With Atomic Precision Coatings
Anders Johansson, PhD, Polla Rouf, PhD, and Joel Hellrup, PhD, review an innovative drug delivery system that uses nanometer-thin, inorganic coatings to turn short-acting drugs into long-acting injectables.
INJECTABLE DEVICES - Delivering Tomorrow’s Injectables to Patients Today: Responding to a New Era of Demand With Purpose-Built Capabilities
Tommy Schornak examines how evolving therapeutic modalities, delivery systems, and regulatory expectations are reshaping the fill finish landscape.
PLATFORM TECHNOLOGY - Developing Innovative Solutions to One of the Top Public Health Threats: Antibacterial Resistance
Jennifer Schneider, PhD, believes immunotherapy holds the potential to revolutionize the treatment of “hard to treat,” chronic, and often recalcitrant infections.
EXECUTIVE INTERVIEW - Plus Therapeutics: Advancing Targeted Radiotherapeutics for Rare & Difficult-to-Treat Cancers
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.
CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm
John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
FORMULATION FORUM - Orally Disintegrating Tablets
Shaukat Ali, PhD, and Jim Huang, PhD, say as more NCEs are being discovered, the industry is weighing all options for evaluating those molecules in different dosages to improve solubility and oral bioavailability. With requirement for taste-masking of bitter drugs with commercially available ODT excipients, it poses additional challenges for improving taste-masking and performance of molecules for the intended usages.
PRECLINICAL SCREENING PLATFORM - From Preclinical Screening to Clinical Optimization: Accelerating Poorly Soluble Drug Development
Andrew Parker, PhD, John McDermott, and Sandeep Kumar, PhD, believe the development of poorly soluble drugs remains a significant challenge in pharmaceutical R&D. However, by adopting an adaptive approach that integrates services from preclinical screening to clinical optimization, developers can achieve significant time- and cost-saving benefits.
LIPID FORMULATION DEVELOPMENT - Why Softgels Are the Technology of Choice
Dipanwita De, PhD, and Kaspar van den Dries say solubility and bioavailability in OSD formulations remain major challenges within the early stages of drug development. While technological innovations have allowed the pharmaceutical industry to make progress in solving this hurdle, choosing formulations that help achieve desirable solubility and bioavailability can help speed up development of the most promising molecules.
CONTAINER SELECTION - Why Container Selection is Key to Overcoming Sterile Fill & Finish Challenges for Next-Gen Biologics
Vincenza Pironti explores the importance of container selection for sterile injectable drug products and outlines key factors to consider to optimize the performance, quality, and efficacy of biologics.
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.
Life Sciences in 2025: Strategic Recalibration & What's Next
Those who succeed in 2026 will be the organizations that set a bold vision, empower cross-functional collaboration, and stay committed to continuous innovation. The future of life sciences is one of extraordinary promise – and the recalibration underway today is setting the foundation for a healthier world tomorrow.
The AI-Driven Path to Precision Therapeutics
Drs. Rotem Gura-Sadovsky and Maayan Eilon-Ashkenazy explore the potential for AI to transform drug discovery, charting a path towards more targeted precision therapeutics.
How PolyPid’s PLEX Unlocks the Potential of Local & Prolonged Release
This article answers the question: what if, instead of relying on systemic delivery, we could create a platform that anchors drugs directly at the site of need and controls its release over weeks or months?
To Improve Upon a Miracle Drug: Overcoming Drug Resistance & Intolerance in CML
Thanks to the pioneering work of researchers advancing our knowledge of basic science and cancer, the field has been able to transform the lives of millions of patients with CML. But challenges remain, and everyone in the industry strives to improve upon the “miracle drug” imatinib, that was approved almost 25 years ago.
EXECUTIVE INTERVIEW - Incannex Healthcare: Pioneering the Future of Cannabinoid and Psychedelic Therapies
In this exclusive interview, Latham shares how the company navigates complex global regulatory pathways, building strategic collaborations, and forging a path toward commercial success that balances both scientific rigor and therapeutic optimism.
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EXCLUSIVE WHITEPAPERS
WHITE PAPER - Advancements in Intradermal Delivery: From Historic Techniques to Modern Innovations
This white paper explores the evolution of intradermal delivery methods, comparing historic methods of delivery such as the Mantoux technique with modern innovations such as the Terumo Immucise™ Intradermal Injection System.
WHITE PAPER - An Insoluble Problem? Overcoming Oral Drug Solubility Challenges With Functional Polymers
There are three key factors that need to be controlled when designing a drug product for solubility enhancement: the polymeric carrier; the manufacturing process; and the match to the desired API. By controlling these three factors bioavailability, drug release profile and manufacturability of your final drug product can be controlled.
WHITEPAPER - Drug Delivery – Recent Trends, Enabling Technologies, In-Vitro-In-Vivo Predictions & Personalized Medicine
Enabling technologies such as Nanotechnology, Amorphous Solid Dispersions, Self-emulsifying/nanoemulsifying drug delivery systems (SEDDS/SNEDDS) or Lipid Nano Particles (LNPs) for oral delivery are key elements for the development of complex and difficult to develop small molecules.
WHITEPAPER - 3D Reconstructed Skin Models: Transforming Clinical & Safety Testing
Targeted at researchers, toxicologists and formulation scientists in the clinical and dermatological fields, the white paper provides essential insights into how advanced in vitro skin and mucosal tissue systems are reshaping research and development practices.
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.
EXCLUSIVE WEBINARS
ON-DEMAND WEBINAR: Drug Product Design for Delivery of Challenging Molecules
In this talk we illustrate several case studies demonstrating how a fundamental understanding of molecular properties combined with a strategic vision for drug product design can lead to effective and advanceable formulations for even the most challenging drug products.
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.
MARKET NEWS & TRENDS
Plus Therapeutics Announces Read Out of Type B Meeting With FDA With Goal of Accelerating Approval of REYOBIQ for Leptomeningeal Metastases
Plus Therapeutics, Inc. recently announced the completion of a Type B meeting with the US FDA on next steps on REYOBIQ pivotal trial strategy for…
ProMed Pharma Announces Agreement With Undisclosed Partner for Dedicated Manufacturing Suite at New Niagara Ln Facility
ProMed Pharma, a leading contract development and manufacturing organization (CDMO) specializing in long-acting injectable and implantable drug delivery systems, today announced it has entered into…
NRG Therapeutics Announces First Participants Dosed in its First-in-Human Phase 1 Clinical Trial of a Disease-Modifying Treatment for ALS/MND & Parkinson’s
NRG Therapeutics Ltd. recently announced the first participants have been dosed in its first-in-human Phase 1 clinical trial of its lead candidate NRG5051, which is…
Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD
Complement Therapeutics GmbH (CTx) recently announced the US FDA has granted Fast Track Designation for CTx001, the company’s lead gene therapy candidate for the treatment…
Atsena Completes Dosing in Part B of the Phase I/II/III LIGHTHOUSE Trial Evaluating ATSN-201 to Treat X-linked Retinoschisis and Announces Plans for Initiation of Pivotal Part C Cohort
Atsena Therapeutics recently announced dosing is complete in patients enrolled across all adult and pediatric cohorts in Part B of the Phase I/II/III Lighthouse Trial…
MedPharm Announces Successful FDA Inspection of its cGMP Commercial Manufacturing Facility
MedPharm recently announced its topical drug product manufacturing facility in Durham, NC, has successfully completed a US FDA inspection for commercial manufacture of drug products.…
SpliceBio Initiates Dose-Expansion Portion of Phase 1/2 ASTRA Clinical Trial for SB-007, a Dual-AAV Gene Therapy for Stargardt Disease
SpliceBio recently announced the first patient has been dosed in the Part B dose-expansion portion of the Phase 1/2 ASTRA clinical trial of SB-007, a…
Credence MedSystems Announces Commercial Supply Agreement With Global Biopharmaceutical Leader
Credence MedSystems, an innovator in advanced injectable delivery systems that solve unmet market needs for the pharmaceutical industry, recently announced it has entered into a…
Roswell Park Study Shows IL-36 Gamma "Armored" CAR T Cells Can Eradicate Solid Tumors
A laboratory study out of Roswell Park Comprehensive Cancer Center outlines a new way to boost the effectiveness of chimeric antigen receptor (CAR) T-cell therapy…
Verista Expands Automation & Validation Capabilities With Acquisition of Integral Solutions
Verista recently announced the acquisition of Integral Solutions. Based in Columbus, OH, Integral Solutions is a life sciences business and technology services firm that specializes in…
Sharp Sterile Manufacturing Increases Capacity With $28-Million Investment
Sharp Sterile Manufacturing recently announced a $28-million expansion of its site in Lee, MA. The enhanced state-of-the-art facility will strengthen opportunities for highly skilled engineering…
ProBioGen & Zag Bio Forge Strategic CMC Partnership to Advance Fc-Fusion Autoimmune Therapy
ProBioGen recently announced the signing of a Master Service Agreement (MSA) with Zag Bio, Inc., a biotechnology company developing thymus-targeted therapies to induce central immune…
Autolus Therapeutics to Evaluate Automated Manufacturing of AUCATZYL (obe-cel) on the Cellares Cell Shuttle Platform
Autolus Therapeutics plc and Cellares Corp recently announced that Autolus will assess the feasibility of Cellares’ Cell Shuttle platform to complement its commercial manufacturing operations…
Nimbus Therapeutics Announces Research Collaboration & License Agreement With Lilly for Novel Oral Obesity Treatment
Nimbus Therapeutics, LLC recently announced it has entered into a multi-year research collaboration and exclusive, worldwide license agreement with Eli Lilly and Company to develop…
FDA Approves New 2-Gram Presentation of Fibryga, Enhancing Convenience & Precision in Treating Acquired Fibrinogen Deficiency
Octapharma USA, Inc. recently announced the US FDA has approved a new 2-gram presentation of Fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement…
Zenas BioPharma Announces Positive Results from Phase 3 Trial of Obexelimab in Immunoglobulin G4-Related Disease
Zenas BioPharma, Inc. recently announced positive results from the Phase 3 INDIGO trial of obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). Obexelimab met the primary endpoint,…
Protara Therapeutics Receives Both FDA Breakthrough Therapy & Fast Track Designations for TARA-002 in Pediatric Patients With Lymphatic Malformations
Protara Therapeutics, Inc. recently announced the US FDA has granted both Breakthrough Therapy and Fast Track designations for TARA-002, the Company’s investigational cell-based therapy, for…
FUJIFILM Irvine Scientific Now Officially FUJIFILM Biosciences
FUJIFILM Biosciences recently announced it has officially changed its legal name from FUJIFILM Irvine Scientific, Inc., to FUJIFILM Biosciences Inc., effective January 1, 2026. The…
Symbiosis Begins Commercial Manufacturing at New FDA-Inspected Facility
Symbiosis Pharmaceutical Services (Symbiosis) has recently manufactured its first 10,000 vial batch at the company’s new facility in Stirling, UK. The project, delivered for one of…
Medicus Pharma Announces Engagement With Reliant AI to Develop AI-Driven Clinical Data Analytics Platform
Medicus Pharma Ltd. recently announced it has entered into non-binding letter of intent (LOI) with Reliant AI Inc., a decision-intelligence company for the life sciences, specializing in…
