Formulation Development
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.
EXCLUSIVE ONLINE CONTENT
Lonza Significantly Expands Its Capsule Manufacturing Capacity
Lonza recently announced a $93-million investment in its Capsules and Health Ingredients (CHI) Division, a dosage form delivery partner to the biopharma and health nutrition industry…..
Quantum Genomics Enters Exclusive Licensing & Collaboration Agreement With Qilu Pharmaceutical
Quantum Genomics recently announced it has entered into an exclusive licensing and collaboration agreement with Qilu Pharmaceutical to develop and commercialize….
NGM Expands Oncology Portfolio With First Immuno-Oncology Development Candidate
NGM Biopharmaceuticals, Inc. recently announced the expansion of its oncology portfolio with its first immuno-oncology development candidate….
BrainStorm Cell Therapeutics & Catalent Announce Manufacturing Partnership
Catalent and BrainStorm Cell Therapeutics Inc. recently announced an agreement for the manufacture of NurOwn, BrainStorm’s autologous cellular therapy being investigated for the treatment of….
WHITE PAPER: Outsourcing Analytical Testing for Biologics
Analytical testing required to support CMC activities of biologics is highly sophisticated, and is becoming more so as the modalities of….