2024 Respiratory Drug Development eBook – CDMOs Will Become More Essential to Inhalation Device Programs
In this fifth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
PLATFORM TECHNOLOGY - Antibody Oligonucleotide Conjugates (AOCs™) - Revolutionizing a New Class of Targeted RNA Therapeutics
Arthur A. Levin, PhD, highlights the first-ever successful targeted delivery of RNA to muscle in humans, a revolutionary advancement for the field of RNA therapeutics that may help transform the opportunities to advance research targeting many previously untreatable diseases in the years ahead.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners
Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.
FORMULATION FORUM - Advances in Drug Delivery by Antibody Drug Conjugates (ADCs)
Shaukat Ali, PhD, and Jim Huang, PhD, focus on two aspects of drug delivery through ADCs. One, where an antibody is conjugated via a ligand with functionalized LNPs carrying cytotoxic drugs; and two, where an antibody is conjugated directly with drug through a linker at the specific site.
AMORPHOUS SOLID DISPERSION SPECIATION - Impact of Polymer Chemistry & Drug Properties
Wesley K. Tatum, PhD, focuses on the use of in vitro techniques for characterizing ASD performance and on how these techniques can be used to help better understand the role of polymer chemistry in ASD performance.
EXECUTIVE INTERVIEW - Lonza: Navigating Today’s Challenges in Drug Solubility & Bioavailability
Adi Kaushal, Director and Technology Head, Bioavailability Enhancement at Lonza, discusses solubility and bioavailability challenges and Lonza’s approach.
DEVICE STUDY - Putting Auto-Injector Interchangeability to the Test
Alex Fong, MBA, says many factors need to be taken into account when deciding whether patients can successfully switch to a different drug delivery device because if patients struggle to cope with a new device, there is a risk they will miss out on vital doses of medication.
EXECUTIVE INTERVIEW - PCI Pharma Services: A Consultative Approach to High Potency Formulation Development
David O’Connell, Director of Scientific Affairs at PCI Pharma Services, explains how important it is to choose the right CDMO partner to accompany you throughout the drug product lifecycle.
THERAPEUTIC FOCUS - The Unmet Need of Agitation in Alzheimer’s Disease
Ram Mukunda, MS, and Evelyn Gutiérrez, and Claudia Grimaldi report on IGC-AD1, the first natural cannabinoid-based investigational drug to be tested in human FDA trials for the treatment of AD, which has shown promising results in treating agitation in Alzheimer’s patients.
CONTAINER PLATFORMS - Ready-to-Use Containers: Real Benefits, Important Challenges & Evolving Value
Gregor Deutschle and Gabriele Maier examine key benefits, dynamics driving the adoption of RTU container platforms, and several important areas of continuing evolution in the RTU market.
PFS MARKET TRENDS - Partnerships With Pharma Packaging Specialists Will be Key to PFS Product Success in 2024
Pieter Vercruysse says to overcome various challenges in 2024, pharma companies need to establish close partnerships with specialists focusing on PFS packaging.
EXECUTIVE INTERVIEW - Coya Therapeutics: Unlocking the Power of Tregs to Combat Inflammation & Fight Neurodegenerative Diseases
Dr. Howard Berman, Founder and CEO of Coya Therapeutics, discusses how the company is leveraging Tregs, its investigational products and the conditions targeted, Coya’s significant partnership with Dr. Reddy’s Laboratories, and his goals throughout the next 5 years.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Delivery: Next-Gen Injections Feature Technology & Reconstitution
Contributor Cindy H. Dubin highlights innovations from key players in parenteral delivery and prefilled syringes, with focuses on safety, meeting regulatory requirements, cost, fill/finish, and dosing.
SCALING MANUFACTURING - Collaboration Between a Device Supplier & Equipment Manufacturer to Meet the Needs of Patients, End-Users & Pharma Manufacturers
John Merhige and William (“Bill”) Jaworski present how their two companies have worked closely together, using creative manufacturing strategies to produce a wide array of problem-solving drug delivery systems.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: Expanding Capabilities to Exceed Customer Expectations
Tom Sellig, CEO of Adare Pharma Solutions, discusses how he has realized various achievements and about the company’s focus on addressing special needs in the market, its global expansion, and where he expects to take the company in the future.
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.
Meet Gaelic Laboratories, Your Trusted Testing & Manufacturing Partner
Gaelic Laboratories today announces its new website, which contains details about this world-class Beta-Lactam (penicillin) manufacturer’s….
How AbbVie Operations & Contract Manufacturing Has Prepared Global Parenteral Sites for the Annex 1 Compliance Requirement
This article explains the key changes that pharmaceutical companies and CMOs engaged in manufacturing and fill-finish need to consider, as well as what AbbVie Contract Manufacturing (AbbVie CMO) is doing to ensure its global operations and aseptic fill-finish sites are in compliance with the revised regulations….
3 Key Things to Consider When Choosing a Partner for Your Tech Transfer
One way of streamlining tech transfer is to partner with a CMO demonstrating a proven track record across the entire drug development and manufacturing continuum. Not only will an experienced CMO partner have the scientific….
Lyophilization Trends in Pharma & Biopharma Drug Development
This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
Premium Cell Culture Ingredients From Actylis
Thanks to our many GMP manufacturing sites located in North America, Europe and Asia we can provide the critical ingredients for your Biopharma manufacturing applications.
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EXCLUSIVE WHITEPAPERS
WHITEPAPER - Unlock the Secrets of Spray Drying for Sticky APIs
It is widely reported that 40% of New Chemical Entities (NCEs) in the pharmaceutical industry are poorly soluble, leading to inadequate bioavailablity. Spray drying is one of the most promising particle engineering technologies….
WHITEPAPER - Versatility of Geleol™ Mono- and Diglycerides NF
Geleol exerts different functional roles, depending on the drug, formulation, and the process applied. It may serve as carrier and release modifier for oral formulations and plasticizer in tablet film coating processes. It may be combined with polymers and/or other non-digestible lipids like Compritol®….
WHITEPAPER - Efficient Development of Miniature Drug-Loaded Implants
Drug-eluting implants offer a unique approach to overcoming challenges associated with traditional drug delivery methods. They can provide sustained, continuous release of a therapeutic at…
WHITEPAPER - A Holistic Approach to Getting the First Batch Right
Mark Rauckhorst, director of supply chain and project management at leading, global contract development and manufacturing organization (CDMO) Vetter, will share his expert insights on how an outsource….
WHITEPAPER - Continuous Flow - An Emerging Alternative
In the whitepaper Continuous Flow: An Emerging Alternative, Curia experts discuss how continuous flow chemistry and processing offer an alternative pathway. The paper explores its….
EXCLUSIVE WEBINARS
WEBINAR - Development of Orally Delivered GLP-1 Therapeutics…From Diabetes to Obesity and Beyond
Join Quotient Sciences’ experts on July 18 as we explore the latest developments in orally-delivered GLP-1 agonists, the potential for these therapeutics and overcoming the manufacturing challenges.
WEBINAR - 2024 Trends in Topical Drug Delivery: Insights & Innovation
This webinar will discuss some of the key trends from these leaders in the topical market on both a global and regional level, including the increased importance of sensory properties and the rise in non-conventional product formats, among others…..
WEBINAR - Enabling Upstream Intensified Bioprocessing
Intensified upstream bioprocesses are being developed to increase productivity while reducing footprint, costs, and timelines for manufacturing. The higher cell densities generated by….
WEBINAR - Nanoparticle Suspensions: History, Applications & CMC Aspects
This webinar describes the history, CMC aspects, and potential applications of nanoparticle suspensions (NSs). This drug delivery technology should be considered for crystalline, sparingly water-soluble APIs. The presentation highlights….
WEBINAR - Impact of Process Re-design on Sustainability in Pharmaceutical Small Molecule Manufacturing
Join us for an upcoming webinar that delves into a crucial issue in the pharmaceutical industry. Recent research has revealed a surprising fact: the pharmaceutical sector has a larger carbon footprint than even the automotive industry, especially when we consider the entire supply chain’s impact on
MARKET NEWS & TRENDS
Selkirk Pharma Appoints Colleen Dixon as New CEO
Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced…
Ipsen & Foreseen Biotechnology Announce Exclusive Global Licensing Agreement for Antibody-Drug Conjugate With First-In-Class Potential
Ipsen and Foreseen Biotechnology recently announced an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential. FS001 targets a novel tumor-associated…
OKYO Pharma to Initiate Neuropathic Corneal Pain Trial for OK-101
OKYO Pharma Limited recently announced its plan to advance OK-101 into a Phase 2 clinical trial of neuropathic corneal pain which is expected to begin…
Rentschler Biopharma Announces New State-of-the-Art Production Line in Massachusetts is Fully Operational
Rentschler Biopharma SE recently announced the company’s new state-of-the-art production line, formerly known as the Rentschler Biopharma Manufacturing Center (RBMC), in Milford, MA, is now…
Kane Biotech Signs Worldwide License Agreement With Omni Bioceutical Innovations
Kane Biotech Inc. recently announced it has signed a worldwide license agreement with Arizona-based Omni Bioceutical Innovations Inc. for its coactiv+ line of scalp care…
Lisata Therapeutics’ Certepetide Shows Promise in Improving Standard Treatment for Intrahepatic Cholangiocarcinoma in a Preclinical Model
Lisata Therapeutics, Inc. recently announced promising preclinical results for its investigational candidate, certepetide (formerly LSTA1). The data, presented in a poster by Dr. Dan G.…
CARGO Therapeutics Announces Phase 1 Clinical Study of Firi-cel CAR T-Cell Therapy
CARGO Therapeutics, Inc. recently announced The Lancet has published favorable data from a Phase 1, single-center clinical study (NCT04088890) by Stanford Medicine (Stanford), evaluating firi-cel,…
Oragenics Improves Intranasal Drug Formulation for Treating Concussed Patients
Oragenics, Inc. recently announced it has developed a new formulation for its novel neurosteroid. Oragenics’ lead drug candidate for concussion, ONP-002, is a new chemical…
EnPlusOne Biosciences Reveals Breakthrough Enzymatic Synthesis of Leqvio Antisense Strand
EnPlusOne Biosciences, Inc. recently announced it had achieved the successful synthesis of the antisense strand of the commercially approved siRNA drug, Leqvio (inclisiran), a treatment…
Intensity Therapeutics Announces First Patient Dosed in its Global Randomized, Phase 3 Study in Metastatic Soft Tissue Sarcoma
Intensity Therapeutics, Inc. recently announced the first US patient has been dosed in its Phase 3 study to treat metastatic sarcoma (NCT06263231). The trial is…
Preclinical Analyses of TGR-63 Demonstrate Blood-Brain Barrier Permeability & Safety Profile
IGC Pharma, Inc. recently announced preclinical data demonstrating TGR-63’s potential as an effective treatment for Alzheimer’s disease. Analysis of the partition coefficient and mass spectrometry…
Avalo Therapeutics Announces Active IND for AVTX-009, an anti-IL-1β mAb, to Treat Hidradenitis Suppurativa
Avalo Therapeutics, Inc. recently announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS)…
Athira Pharma Announces Last Patient Completed LIFT-AD Clinical Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease
Athira Pharma, Inc recently announced the completion of dosing for the last patient in the Phase 2/3 LIFT-AD clinical trial evaluating fosgonimeton in people with…
Prelude Therapeutics Announces Clinical Collaboration With Merck
Prelude Therapeutics Incorporated recently announced it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the US…
uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase 1/2 Trials for Huntington’s Disease Treatment
uniQure N.V. recently announced updated interim data including up to 24 months of follow-up data from 29 treated patients enrolled in the ongoing US and…
Obsidian Therapeutics Announces FDA Fast Track Designation for Advanced Melanoma Treatment
Obsidian Therapeutics, Inc. recently announced the US FDA has granted Fast Track Designation to OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte…
Zevra Announces FDA Advisory Committee Meeting to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C
Zevra Therapeutics, Inc. recently announced the US FDA has indicated that it will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee…
Skinvisible Unveils Promising Data on Transdermal Obesity Formulations
Skinvisible Pharmaceuticals, Inc. recently announced exciting data demonstrating its transdermal delivery of obesity drugs (and other glucose-controlling drugs), including a GLP-1 agonist and CB-1 receptor…
MedPharm & Tergus Pharma Merger Forms Topical & Transepithelial CDMO Leader
MedPharm, Ltd., an Ampersand Capital Partners portfolio company, and Tergus Pharma, a Great Point Partners portfolio company, recently announced a merger. The combined topical and…
Triclinic Labs, Inc. & ELDICO Scientific Announce Microcrystal Electron Diffraction Partnership
The two companies recently announced an exclusive strategic collaboration to introduce Microcrystal Electron Diffraction services and instruments to the North American market. Microcrystal Electron Diffraction…
