Formulation Development
Celanese Announces Agreement With Glaukos Corporation for Sustained-Release Glaucoma Treatment
Celanese Corporation, a global specialty materials and chemical company, recently announced it has entered into an agreement with Glaukos Corporation to supply its VitalDose® Drug Delivery Platform for use as….
QSAM Biosciences Opens Enrollment of the Second Cohort of Patients in its Phase 1 Study of Targeting Metastatic Bone Cancer
QSAM Biosciences Inc. recently announced the opening of enrollment into the second grouping of participants (Cohort 2) after completing Cohort 1 in February in its…
AI Therapeutics Announces Positive Results From Phase 2a Biomarker-Driven Trial of AIT-101 in Patients with C9ORF72 Amyotrophic Lateral Sclerosis
AI Therapeutics, Inc. recently announced positive results from a Phase 2a clinical trial of AIT-101 (LAM-002A) in patients with C9ORF72 amyotrophic lateral sclerosis (ALS). In…
Bora Pharmaceuticals & Celltrion Partner to Expand OSD Capabilities in APAC Market
Bora Pharmaceuticals Co., Ltd. and Celltrion Asia Pacific Pte., Ltd. recently announced their partnership to contract manufacture and commercialize a range of oral dosage form drugs (OSD) across the APAC region…..
RespireRx Pharmaceuticals Establishes Research Collaboration With University College London to Study the Use of AMPAkines for the Treatment of GRIA Disorders
RespireRx Pharmaceuticals Inc. recently announced entering into a material transfer agreement with University College London (UCL) as part of a collaborative research effort involving Dr.…
Lonza & ABL Bio Collaborate in the Development & Manufacture of Bispecific Antibody Product
Lonza recently announced it has an agreement with ABL Bio to support the development and manufacturing of ABL Bio’s new bispecific antibody product….
Zevra Therapeutics Announces Submission of IND for KP1077 in Narcolepsy
Zevra Therapeutics, Inc. recently announced the submission of an Investigational New Drug (IND) application seeking authorization from the US FDA to begin a Phase 1…
Caribou Biosciences Announces FDA Granted Fast Track Designation for Allogeneic CAR-T Cell Therapy for Relapsed or Refractory Multiple Myeloma
Caribou Biosciences, Inc. recently announced the US FDA has granted Fast Track designation to CB-011, which is being developed for relapsed or refractory multiple myeloma…
Eckert & Ziegler to Supply POINT Biopharma With Actinium-225
Eckert & Ziegler (ISIN DE0005659700, TecDAX) and a subsidiary of POINT Biopharma Global Inc. have signed an agreement on the supply of Actinium-225 (non-carrier-added Ac-225).…
Absci Partners With Bioinformatics Company M2GEN to Accelerate Drug Creation for Oncology
Absci Corporation and M2GEN recently announced a partnership to create new cancer medicines and bring them to market at unprecedented speed. Absci’s generative AI drug creation platform will tap into M2GEN’s clinical and….
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.