Formulation Development
Catalent Launches OneXpress Solution to Accelerate Oral Dosage Products From Clinic to Launch
Catalent recently announced the launch of its new OneXpress service for the integrated development, scale up, and manufacturing of new oral solid dosage forms. The…
AiViva Biopharma Initiates Phase 1/2 Clinical Trial of AIV001 for Nonmelanoma Skin Cancer
AiViva Biopharma Inc. recently announced it has begun dosing patients diagnosed with superficial or nodular basal cell carcinoma (BCC) with AIV001. AIV001 is AiViva’s novel…
Proveris Scientific Research Collaboration: New Generation Technologies for Improved Measurement of Pharmaceutical Aerosols
Proveris Scientific Corporation recently announced its research collaboration with The University of Sydney and Macquarie University on a project to develop a new generation of technologies for improving….
Recipharm Signs Agreement With Arcturus Therapeutics to Support the Manufacture of LUNAR-COV19 (ARCT-021) Vaccine Candidate
Recipharm has recently entered into an agreement with Arcturus Therapeutics, a leading US-based clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and….
First Commercial Drug Manufactured Via Ajinomoto Bio-Pharma Services’ AJIPHASE Technology Receives FDA Approval
Ajinomoto Bio-Pharma Services recently announce the US FDA has approved the first commercial drug manufactured via Aji Bio-Pharma’s proprietary AJIPHASE production process…..
Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion
Bristol Myers Squibb and MyoKardia, Inc. recently announced a definitive merger agreement under which Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or….
Evonik Launches New Oral Drug Delivery Technology for Enteric Protection & Rapid Release in the Upper Small Intestine
Evonik has recently launched an advanced oral drug delivery technology that provides enteric protection followed by rapid, homogeneous release for effective….
PLATFORM TECHNOLOGY - Morphomer(TM) & SupraAntigen(TM) Platforms: Targeting Misfolded Proteins in Neurodegenerative Disorders
Andrea Pfeifer, PhD, details the efforts to develop the therapeutic and diagnostic tools necessary to enable precision medicine approaches targeting the right protein, at the right time, in the right patient.
FORMULATION FORUM - Parenteral Sustained Delivery of ASD-005 Liposomal Formulation: A Case Study in Applications of Lipid-Based Nanoparticle Carriers
Jim Huang, PhD, presents an investigation aimed at studying the administration of a liposomal form of a third-generation β-blocker, ASD-005, by injectable route of administration to efficiently manage emergency hypertension and congestive heart failure.
ASSAY DEVELOPMENT - Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma
Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.
PEGYLATION - PEGylation - Three Decades of Product Approvals & Technology Development
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
CDMO CASE STUDY - AJILITY: Streamlining Drug Product Manufacturing
Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
DRUG DELIVERY - Recognizing the Patient Potential for Transdermal Drug Delivery
Sally Waterman, PhD, and Vasiliki Nikolaou, PhD, explain how transdermal drug delivery patches have the potential to significantly improve not only the outcome of treatments, but also the quality of life for those patients using them.
EXECUTIVE INTERVIEW - Immunic Therapeutics: Developing Next-Generation Oral Drugs in Chronic Inflammatory, Autoimmune & Infectious Diseases
Daniel Vitt, PhD, Immunic’s Chief Executive Officer and President, discusses his company’s pipeline of selective, small molecule therapies aimed at treating chronic inflammatory and autoimmune diseases, and its recent progress.
DEVICE DEVELOPMENT - Designing Devices for Inhaled Drugs
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OVER-ENCAPSULATION CAPSULES - Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?
Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.
EXECUTIVE INTERVIEW - Enteris BioPharma: Pioneers in Oral Formulation Development
Dr. Rajiv Khosla, CEO of Enteris BioPharma, discusses how his company’s innovative oral formulation technology is helping the pharmaceutical industry overcome the hurdle of low bioavailability to reshape treatment categories and expand market opportunities with minimal financial and regulatory risks.
OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
Mott's Controlled Release Drug Diffusion Studies Reduce In Vitro Test Time by Over 90% & Narrow Scope of Animal Trials
Device diffusion testing is a critical step that can delay the time for an implantable drug delivery device to get through clinical trials, regulatory hurdles and ultimately, to market. Mott conducts controlled release studies for….
Veru Completes Enrollment of Phase 2 Clinical Trial of Novel Oral Drug
Veru Inc. recently announced it has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for…
