SPECIAL FEATURE – Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
PRODRUG TECHNOLOGY – Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs
Travis Mickle, PhD, indicates key properties that prodrugs can potentially modify generally fall within one or more of the ADME categories, with the goal being the creation of an NCE that optimizes the performance, utility, and potential life-cycle management of the parent drug.
RNA EDITING – New Editing Technology Enables Body to Repair its Own RNA
Daniel de Boer explains how the Axiomer technology, a powerful RNA-editing technique that enables the body to repair itself, is being developed as a next-generation therapeutic option for genetic disorders.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2018 product approvals.
DRUG DISCOVERY – Validated Phenotypic Approach to Neuropsychiatric Drug Discovery
Emer Leahy, PhD, reviews how the SmartCube platform represents a novel approach to discovering the next generation of breakthrough treatments for schizophrenia and other neuropsychiatric disorders.
ARTIFICIAL INTELLIGENCE – Practical Applications of Artificial Intelligence (AI) for Drug Data Quality & Research
Robert Stanley believes by treating AI as one more tool within a broad data quality toolkit, and by focusing narrowly on specific research and business bottlenecks, it is possible to efficiently bring real practical benefits to research and business.
MULTIPARTICULATE FORMULATIONS – Using Multiparticulate Technology to Develop Pediatric Drug Products
Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.
NANOPARTICLE DELIVERY – Ultra-Small Particles Offer Big Hope in Cancer Theranostics
Kai Ma, PhD, Ulrich Wiesner, and Michelle Bradbury, MD, PhD, believe ultra-small sub-10 nm particles hold unique properties and represent an emerging area of investigation for biomedical applications.
EXECUTIVE INTERVIEW – SK life science: Challenges of Developing Therapies for Neurological Diseases
Sebby Borriello, Vice President & Chief Commercial Officer, speaks about the challenges and trends surrounding development of therapies for neurological diseases.
FORMULATION FORUM – Formulation Research Strategy for Discovery-Stage New Drug Candidates
Jim Huang, PhD, and Edward Orton, PhD, say it is critically important CROs or CDMOs that support discovery and preclinical research have the requisite preformulation, formulation, and biopharmaceutics expertise as well as the proprietary methodologies to develop formulations from small quantities of drug candidates for different routes of administration.
CHARACTERIZATION CORNER – From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
SPECIAL FEATURE – Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
EXCLUSIVE ONLINE CONTENT
Enterome Announces Research Collaboration With Dana-Farber Cancer Institute
Enterome recently announced it has entered into a research and development collaboration with Dana-Farber Cancer Institute to evaluate and develop gut microbiome-derived antigens as potential cancer immunotherapies.
Amphastar Pharmaceuticals Receives ANDA Approval for Multi Dose Vial Drug
Amphastar Pharmaceuticals, Inc. recently announced the US FDA granted approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) Multiple Dose Vial (MDV).
Aptar Pharma’s Nasal Device Approved by FDA for Breakthrough Treatment
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
Proper Fill & Finish in Clinical Development Requires a Comprehensive Approach
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.
Ajinomoto Bio-Pharma Services Announces Capital Expansion to Fuel Growth
Ajinomoto Bio-Pharma Services recently provided an update on several of its capital projects currently underway in both the United States and Belgium.
Procarta Announces Significant Investment for New Class of Antibiotics
Procarta Biosystems recently announced $1.7 million of new funding from the Novo Holdings REPAIR Impact Fund to support development of novel therapies to combat antimicrobial resistance (AMR).
Biogen Announces Agreement to Acquire Nightstar Therapeutics
Biogen recently announced it has entered into an agreement to acquire Nightstar Therapeutics, a clinical-stage gene therapy company based in London, United Kingdom, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders.
Catalent Invests Over $27 Million to Commercialize ODT Technology
Catalent Pharma Solutions recently announced that it is to invest more than $27 million to commercialize its next-generation oral disintegrating tablet (ODT) technology, Zydis Ultra.
Nemera’s Preservative-Free Multidose Eye Dropper Approved for Santen’s Drug in 29 European Countries
Nemera recently announce its multidose eye dropper Novelia has been approved for the preservative-free formulation Cosopt iMulti (20 mg/ml dorzolamide + 5 mg/ml timolol eye drops, solution).
SGS Appoints Biologics Manager at Expanded Life Sciences Facility in Illinois
SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, today announced the appointment of Dr. Haris Jamil as Biologics Manager of its recently expanded biopharmaceutical testing facility in Lincolnshire, Illinois, USA.
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