Navigating the Fill Finish Process - e-book
You’re here, likely because you are seeking formulation, sterilization, and filling services for your drug. Our guide maps out the journey from onboarding to batch release and highlights facility differences between CMOs so you can understand the impact on your product quality and safety. So, let’s get started!
SPECIAL FEATURE - Injection Devices: Faster, Integrated, and Flexible for the IV to SC Transition
Contributor Cindy H. Dubin speaks with several companies who highlight how device developers are addressing various challenges while still ensuring precise dosage control and patient compliance.
SUBCUTANEOUS INJECTIONS - A New Dimension for an Enhanced Injection Experience
Enrico Barichello and Crystal Salvans explore the impact of market trends, focusing on the technical and clinical challenges associated with delivering large-volume, high-viscosity subcutaneous injections. They also highlight the need for optimized delivery systems that can accommodate these formulations without compromising usability or efficacy, as well as the potential advantages such systems may offer for non-viscous injections.
FORMULATION FORUM - Hot Melt Extrusion – An Enabling Technology for Poorly Soluble Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say in spite of many challenges, drug manufactures continue to look for non-conventional, and often novel, polymers to expedite the development of innovative molecules coming out of discovery when none of the conventional technologies do not meet the desired objectives.
PULMONARY DELIVERY - Development of Pulmonary Dosage Forms for the Successful Delivery of Complex Molecules
Richard Johnson, PhD, believes there is growing interest in next-generation pulmonary delivery devices that can overcome delivering drugs more efficiently into the deep lung and also delivering thermally sensitive drugs that are unstable in solution.
EXECUTIVE INTERVIEW - Lonza & Ethris: Advancing mRNA Vaccines: Room-Temperature Stable, Spray-Dried Formulations for Enhanced Mucosal Delivery
Kim Shepard, Director of Advanced Drug Delivery at Lonza, and Carsten Rudolph, PhD, Co-founder and Chief Executive Officer at Ethris, discuss the main objectives of the collaboration and the benefits of spray-dried mRNA vaccines.
EXECUTIVE INTERVIEW - ALZpath: A Diagnostic Assay Changing the Future of Alzheimer’s Disease
Jacob Hunter, Chief Business Officer, ALZpath, Inc., discusses the development and deployment of the company’s proprietary pTau217 antibody, bridging the gap between detection and treatment to improve patient outcomes globally.
FORMULATION DEVELOPMENT - Innovative Drug Delivery Approaches for GLP-1 Agonists: Enhancing Medication Adherence & Treatment Outcomes
Nasrin Mahmoudi, PharmD, PhD, and Michael Baumann, highlight recent developments in GLP-1 agonist formulations and delivery methods, including advanced injectable formulations, novel oral delivery systems, and topical formulations.
STERILE INJECTABLE MANUFACTURING - Solving Complexity & Strategies for Commercial Success
Jennifer Gattari explores the key forces driving change in the SI space and outlines the core considerations manufacturers must address to deliver safe, effective therapies at commercial scale and the growing reliance on contract manufacturers to help navigate complexity with confidence.
LIPID SOURCING & SELECTION - Navigating the Lipid Landscape: Overcoming the Challenges of Lipid Sourcing & Selection for LNPs
Donald Kelemen, PhD, says one of the most significant challenges lies in selecting and sourcing the molecules at the heart of LNPs: lipids. The right choices can optimize stability, efficacy, and scalability, while the wrong ones can introduce roadblocks that are difficult (and costly) to overcome.
TARGET DISCOVERY PLATFORM - Multi-Omics, SITESEEKER® Technology & the Future of Targeted Protein Degradation
Alberto Moreno, PhD, and Laura Butler, PhD, discuss the challenges associated with gene editing technologies, such as gene-trap, RNAi, and CRISPR technologies, as they do not directly provide functional characterization or inform on the presence of well-defined drug pockets or enzymatic activity of the target genes.
2025 Analytical Testing e-Book - New ICH Guideline Outlines E&L Principles
In this exclusive Drug Development & Delivery e-book, Stevanato Group discusses E&L from the perspective of lyophilized products, common E&L testing challenges, how to mitigate testing risks.
2025 Respiratory Drug Development e-Book - New Devices & Drugs Enhance Compliance & Facilitate Improved Disease Management
In this sixth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
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.
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.
How Can a Stage-Based Program to Determine HME Applicability Benefit Your API?
Low bioavailability due to poor API solubility is one of the major challenges to be overcome when developing oral dosage form drug products. An effective way of addressing this problem is to transform low solubility APIs into amorphous solid dispersions (ASDs) and can often be achieved via hot melt extrusion (HME).
Nitrosamine Risk Assessment and Mitigation in Pharmaceutical Products
This paper explores practical approaches for identifying and mitigating nitrosamine risks in drug products, integrating emerging tools such as predictive machine learning, advanced nitrite testing methodologies, and strategic excipient sourcing.
CAPMUL GDO (Glycerol Dioleate) is a Versatile Excipient for Pharmaceutical Formulations
ABITEC is excited to present its latest excipient, CAPMUL GDO, Glycerol Dioleate. CAPMUL GDO is a high-purity, highly versatile functional lipid
The Benefits of Transparent Pricing: How to Compare CMO Proposals & Know What Your True Costs Will Be
We want your experience as a pharmaceutical professional responsible for evaluating and selecting a CMO to be different. This article will help you be prepared when choosing a CMO from among multiple candidates.
The Value of Expertise in Aseptic Fill Finish Manufacturing of Biologics
One way to mitigate the risk associated with aseptic fill finish manufacturing of biologics is to partner with a contract manufacturing organization (CMO) demonstrating proven expertise in all aspects of biologics production.
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EXCLUSIVE WHITEPAPERS
WHITEPAPER - 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.
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.
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
AM-Pharma Completes Enrollment in Phase 2 Study of Ilofotase Alfa for Prevention of Cardiac Surgery-Associated Renal Damage
AM-Pharma B.V. recently announced that it has successfully completed enrollment of patients in its ongoing Phase 2 clinical trial evaluating ilofotase alfa for the prevention…
Bio-Rad Extends Partnership With Gencurix Through Strategic Agreement for Droplet Digital PCR IVD Oncology Kits in Europe
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, and Gencurix, Inc. (KOSDAQ: 229000), a leading…
Draig Therapeutics Announces US FDA Clearance of IND Application for Phase 2 Study for the Treatment of Major Depressive Disorder
Draig Therapeutics recently announces that it will initiate a Phase 2 study of DT-101, a next-generation AMPA receptor positive allosteric modulator (PAM) for Major Depressive…
Sitryx Receives FDA Clearance of IND Application for Atopic Dermatitis Treatment
Sitryx Therapeutics recently announced it has received clearance from the US FDA for its Investigational New Drug (IND) application for SYX-5219, to support the initiation…
Aerska Launches With $21 Million in Financing to Develop RNAi Medicines for Diseases of the Brain
Aerska, a biotechnology company aiming to redefine the treatment of neurological diseases, recently announced it has raised $21 million in seed financing, co-led by Age1,…
RheumaGen Announces Oral Presentation on HLA Gene-Editing Preclinical Data for Lead Autoimmune Disease Program at ACR Convergence 2025
RheumaGen, Inc., a cell and gene therapy company engineering a new class of therapeutics for major autoimmune diseases, today announced that a human leukocyte antigen…
Fortress Biotech & Urica Therapeutics Announce Crystalys Therapeutics’ $205 Million Series A Financing
Urica Therapeutics, Inc., a Fortress Biotech, Inc. subsidiary, recently announced Crystalys Therapeutics, Inc., in which Urica maintains an equity position, closed a $205 million Series…
Symbiosis Expands Sterile Manufacturing Capacity With Fill/Finish Line Qualification
Symbiosis Pharmaceutical Services has successfully completed qualification of its new FPD 50 Flexicon automated fill/finish line at its new commercial production facility in Stirling, Scotland. The…
VERAXA Biotech & Secarna Pharmaceuticals Initiate Antibody Oligonucleotide Conjugate Alliance in Immunology
VERAXA Biotech, an emerging leader in designing novel cancer therapies and proposed de-SPAC acquisition target of Voyager Acquisition Corp. and Secarna Pharmaceuticals GmbH & Co. KG,…
Sharp Appoints Samantha Wilson Jones as General Counsel
Sharp Services, a leader in pharmaceutical packaging, clinical trial services & sterile manufacturing, has appointed Samantha Wilson Jones as General Counsel and Corporate Secretary of…
Faeth Therapeutics’ R&D Platform Delivers First Cross-Disease Validation Beyond Oncology
Faeth Therapeutics has launched a new R&D initiative aimed at preserving neurocognitive function in children with tyrosinemia type 1 (TT1), marking the expansion of its platform…
HCW Biologics Participates in Virtual Investor What This Means Segment About its Proprietary T-Cell Engager Program
HCW Biologics Inc. recently announced Peter Rhode, PhD, Chief Scientific Officer and Vice President of Clinical Operations of HCW Biologics, participated in a Virtual Investor…
Orexo US Awarded $8 Million by BARDA for OX390 Development Partnership
Orexo AB recently announced its wholly owned US subsidiary, Orexo US, Inc., has been awarded USD 8 million in funding by the Biomedical Advanced Research…
Credence MedSystems & SMC Ltd. Pharma Services Announce Collaboration to Advance Dual Chamber Fill-Finish Capabilities
Credence MedSystems, Inc. (Credence), an innovator in advanced injectable delivery systems that solve unmet market needs for the pharmaceutical industry, and SMC Ltd. Pharma Services…
Harrow to Acquire Melt Pharmaceuticals
Harrow recently announced it has entered into an agreement to acquire Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company pioneering non-opioid, non-IV therapies for sedation for…
Gattefossé Inaugurates New Manufacturing Facility in Texas
Gattefossé, a leading provider of specialty ingredients and formulation solutions for personal care and pharmaceutical industries, celebrated the grand opening of its new manufacturing facility…
AIM ImmunoTech Secures Patent Through 2039 for Novel Cancer Therapy
AIM ImmunoTech Inc. recently announced the Japan Patent Office has issued a patent covering the Company’s proprietary use of Ampligen (Rintatolimod) in combination with checkpoint…
Immuneering Announces Extraordinary 86% Overall Survival at 9 Months in First-Line Pancreatic Cancer Patients Treated With Atebimetinib + mGnP
Immuneering Corporation recently announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP)…
Arecor Announces Co-Development Agreement With US Insulin Pump Device Company
Arecor Therapeutics plc has recently signed a co-development agreement with Sequel Med Tech LLC, a company developing state-of-the-art insulin delivery technologies, to combine AT278 (500U/mL)…
Hovione & Microinnova Partner to Advance Modular Flow Chemistry for Multi-Purpose Manufacturing
Hovione recently announced a partnership to advance the development of multi-purpose, plug-and-play modular equipment for flow chemistry. The companies will work together to test Microinnova’s…
