Formulation Development
Dipharma Expands its Italian R&D Center to Increase its Analytical Services
Dipharma Francis S.r.l. recently announced the completion of the expansion of its Research and Development Center for small molecules at its Headquarters located in Baranzate,…
WHITEPAPER - Unique Manufacturing Challenges Associated With Sterile Eye Ointments
The manufacture of ophthalmic ointments is much more complex than the production of ocular liquid therapies and presents several unique challenges. It is essential for…
INFLAMMASOME INHIBITORS - 21st Century Miracle Drugs: Spotlight on Clinical NLRP3 Inflammasome Inhibitors
Bryan Oronsky, PhD, says traditionally, pharmaceutical development is based on the “magic bullet” concept of “one drug, one target, one disease.” However, with the growing realization that chronic inflammation lies at the center of many, if not all, diseases, it is possible to envision inflammasome inhibitors, which reduce or prevent inflammation, as near-universal treatment panaceas.
FORMULATION FORUM - Tackling Challenging Molecules by Spray Drying: Making the Impossible Possible
Jim Huang, PhD, and Shaukat Ali, PhD, focus on spray drying technology with special reference to polymers and solvents selection, processing conditions, and the challenges with downstream manufacturing, stability, and degradation of APIs in oral dosages.
MICROCRYSTALLINE CELLULOSE - N-nitrosamine Risk Assessments for Oral Dosage Forms
Takako Koyamatsu, Shohei Mikami, PharmD, Obata Kenji, and Julia Shmyrova show how Ceolus™ demonstrated a very low level of nitrite and nitrate that can allow mitigating nitrosamine formation in the drug products with secondary or tertiary amines.
DRUG-ELUTING IMPLANTS - Delivery of RNAi Therapeutics Through Drug-Eluting Implants
Cyonna Holmes, PhD, Karen Chen, MS, and Brian Wilson, PhD, review how localized therapeutic delivery of these therapies through an implant provides an innovative route of administration for chronic conditions that are difficult to dose adequately.
MARKET TRENDS - The Year of Resilience & Flexibility: Six Smart Ways CDMOs Are Preparing for 2023
Carsten Press says with biopharma businesses weathering one unexpected shift after another, it’s no surprise these organizations are looking to their partner networks for one thing above all: the flexibility they need to maximize their own business resilience.
LIPID-BASED EXCIPIENTS - Misconceptions About Lipid-Based Drug Delivery
Rollie Fuller and Ron Permutt provide formulators confidence in using LBDDS as part of formulation development programs, by demonstrating their benefits and key functional mechanisms when used and addressing commonly misrepresented, misinterpreted, and misunderstood LBDDS topics.
BIOAVAILABILITY ENHANCEMENT - Solving Low Solubility Challenges to Optimize Drug Delivery Platforms
David K. Lyon, PhD, discusses how low aqueous solubility NCEs have come to define the innovative pharmaceutical pipelines and how advanced technologies are often required to overcome this issue.
PLATFORM TECHNOLOGY - An Alternative Solution for Peptide Drug Formulation
Michael Neely introduces a unique technology platform and provides examples of how it has solved difficult formulation problems while adding significant commercial value to the resulting drug products.
EXECUTIVE INTERVIEW - ICON: Transforming Clinical Trials in a Rapidly Shifting Landscape
Ute Berger, MD, President, Development & Commercialization Solutions at ICON plc, discusses how with the acquisition of PRA in 2021, it has enhanced its value proposition and how it is transforming clinical trials in a rapidly shifting landscape.
Enlivex Announces Clinical Collaboration to Evaluate Combinations of Allocetra & PD-1 Inhibitor Tislelizumab for Patients With Solid Tumors
Enlivex Therapeutics Ltd. recently announced a clinical collaboration with BeiGene to evaluate the safety and efficacy of Allocetra, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for….
A Novel Immunotherapeutic Approach to Treating Aging-Associated Diseases
HCW Biologics Inc. recently published a pivotal scientific paper in Aging Cell titled Immunotherapeutic approach to reduce senescent cells and alleviate senescence-associated secretary phenotype in mice with Dr. Hing C. Wong, the company’s Founder and CEO, as lead and….
Vico Therapeutics Announces First Patient Dosed in Phase 1/2a Clinical Trial of VO659 in Huntington's Disease & Spinocerebellar Ataxia Types 1 & 3
Vico Therapeutics B.V. recently announced the first patient has been dosed in a Phase 1/2a clinical study evaluating VO659 for the treatment of Huntington's disease…
Comera Life Sciences Announces Expansion of Patent Portfolio Underlying Core Excipient Technology
Comera Life Sciences Holdings, Inc. recently announced the expansion of its patent portfolio with one new patent granted in South Korea and two Notices of…
WACKER, CordenPharma, LMU & HU Berlin Train Machine Learning Algorithm for the Formulation of RNA Actives
Together with Munich’s Ludwig Maximilian University (LMU) and the Humboldt University of Berlin (HU Berlin), Wacker Chemie AG and CordenPharma International GmbH have launched a…
Omega Therapeutics Announces Clinical Supply Agreement to Evaluate the Combination of OTX-2002 & Atezolizumab in Hepatocellular Carcinoma
Omega Therapeutics, Inc. recently announced a clinical supply agreement with Roche to evaluate OTX-2002, its lead candidate in development for the treatment of MYC-driven hepatocellular…
SCYNEXIS & GSK Announce Exclusive Agreement to Commercialize & Further Develop Novel, First-in-Class Medicine to Treat Fungal Infection
SCYNEXIS, Inc. GSK plc recently announced they have entered into an exclusive license agreement for Brexafemme (ibrexafungerp tablets), a US FDA-approved, first-in-class antifungal for the….
PDS Biotech Announces Plan to Initiate Phase 3 Study
PDS Biotechnology Corporation recently announced it has completed key tech transfer, scale up, and manufacturing activities required to initiate a global, multicenter Phase 3 registrational…
Immutep Announces Expansion of Triple Combination Therapy in First Line Non-Small Cell Lung Cancer
Immutep Limited recently announced it has signed an agreement to expand the INSIGHT-003 trial evaluating the combination of eftilagimod alpha (efti), a soluble LAG-3 protein…
