Formulation Development
SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
DRUG DEVELOPMENT - The Promise of Cutting-Edge Microbiome-Based Therapeutics
Andrew Thomson, Brian Carpenter, and Robert Broadnax focus on how developers must strategically address and overcome specific challenges to successfully drive development and eventual adoption of microbiome-based therapies.
Sterling Pharma Solutions Expands Global API Manufacturing Capabilities With Acquisition of Novartis Facility
Sterling Pharma Solutions recently announced it had reached agreement with Novartis to acquire its Ringaskiddy campus (Novartis Ringaskiddy Limited), near Cork, Ireland. Financial details of…
NASAL DELIVERY - Improving Nasal Drug Delivery With Permeation Enhancing Technology
Stuart Madden, PhD, focuses on the use of alkylsaccharides as absorption enhancers for nasal delivery of a wide range of drug types.
FORMULATION DEVELOPMENT - Impact of Excipients & Manufacturing Process on Solubility-Enhanced Ritonavir Tablet Size & Weight Reduction
Gayatri Khanvilkar, MPharm, Ajit Bhagat, and Tejas Gunjikar, PhD, investigate bulking agents and disintegrants to develop efficacious Rotonavir tablets with improved in vitro release.
MARKET LANDSCAPE - The Future of Cancer Care Post-Pandemic: What Doctors, Patients, and the Healthcare Industry at Large Should Expect
Angelos Stergiou, PhD, explains how the COVID-19 pandemic saw failures in the healthcare delivery system not only in general medicine, but also specifically in oncology. At the same time, several opportunities came to light during such a difficult, frightening moment, bringing a number of large- and small-scale innovations forth.
GENE EDITING TECHNOLOGY - Harnessing a Cell’s Natural DNA Repair Process to Develop Medicines With Higher Levels of Precision & Durability
Mariana Nacht, PhD, reviews a new gene editing approach that harnesses a cell’s natural DNA repair process, known as homologous recombination, to insert a corrective copy of the gene (or transgene) at a precise spot in a patient’s genome.
Catalent & TFF Pharmaceuticals Announce New Inhalation Dry Powder Development & Manufacturing Agreement
Catalent and TFF Pharmaceuticals, Inc. recently announced their collaboration agreement focused on the generation, testing, and manufacture of dry powder formulations for a range of…
Editas Medicine Announces Favorable Decision From US PTO in CRISPR Patent Interference
Editas Medicine, Inc. recently announced the USPTO issued another favorable decision to the Broad Institute, Inc. (Broad) involving specific patents for CRISPR/Cas9 editing in human…
CDMOs Need to be Prepared for the Revision of the EU-GMP-Annex 1
Annex 1 of the EU-GMP-Guide Manufacture of Sterile Medicinal Products is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The current revision will have to….
After 25 Years, There is a CEO Transition at Hovione!
Hovione recently announced the Board of Directors and the shareholders have approved the appointment of Dr. Jean-Luc Herbeaux as Hovione’s Chief Executive Officer, effective….
Santhera Signs Gene Therapy Agreement With SEAL Therapeutics
Santhera recently entered into an agreement with SEAL Therapeutics, a spin-off company from the Biozentrum of the University of Basel, which will further develop a….
Durable & Deepening Clinical Responses Observed in Post-Treatment Period of Evelo Bioscience’s Phase 2 Clinical Trial
Evelo Biosciences, Inc. recently announced data from the post-treatment follow-up (Part B) of its Phase 2 trial of EDP1815 in mild and moderate psoriasis, which…
Vallon Pharmaceuticals Announces Issuance of US Patent Covering ADAIR for the Treatment of Cognitive Impairment Associated With COVID-19
Vallon Pharmaceuticals, Inc. recently announced the United States Patent and Trademark Office (USPTO) has issued patent No. 11,253,490 covering the use of its proprietary investigational…
TFF Pharmaceuticals Announces Inhaled Niclosamide Significantly Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2
TFF Pharmaceuticals, Inc. recently announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the company’s inhaled niclosamide product candidate completely….
WHITE PAPER: HPAPI Drug Solid Oral Dosage (SOD) Manufacturing – Ensuring Content Uniformity
What techniques should manufacturers employ when working with low-dose drug products? By: Thomas Daggs, MBA, Vice President, Product Development & Quality Control, and Angelo Consalvo,…
Vaxart’s S-Only COVID-19 Vaccine Candidate Produces Strong-Cross Reactive Mucosal & Systemic Immune Responses in Non-Human Primates
A new study published on BioRxiv.org demonstrates that Vaxart’s S-only COVID-19 clinical vaccine candidate, now being studied by Vaxart in Phase 2 trials, generated antibodies…
BioDelivery Sciences International Announces ELYXYB is Now Available in the US for the Acute Treatment of Migraine
BioDelivery Sciences International, Inc. recently announced the US commercial launch and availability of ELYXYB (celecoxib oral solution), the first and only FDA-approved ready-to-use oral solution…
HiberCell Initiates its Phase 1a/b Clinical Trial in Patients With Advanced Solid Tumors
HiberCell has recently initiated a Phase 1a/b clinical trial of HC-7366, a first-in-class selective, orally bioavailable modulator of General Control Nonderepressible 2 (GNC2) for the…
Cyclerion Therapeutics & Ariana Pharma Announce Artificial Intelligence-Driven Precision Medicine Collaboration
Cyclerion Therapeutics, Inc. and Ariana Pharma recently announced an artificial intelligence-driven, precision medicine collaboration. This collaboration is expected to identify biomarkers of response to refine…
