Formulation Development
2021 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM – Age-Appropriate Pediatric Formulation Development
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
PLATFORM TECHNOLOGY – Overcoming the Challenges of Drug Brain Delivery With a Novel Brain Delivery Vector
Mei Mei Tian, PhD, explains how the xB3 platform has the potential to support development of treatments for CNS diseases that can treat thousands of patients in the years ahead.
POLYMERIC DELIVERY SYSTEM – Next-Generation Long-Acting Implantables Using Surface-Eroding Elastomers
Stephanie Reed, PhD, Carissa Smoot, and Dennis Shull describe how PGSU ultimately offers many advantages over other polymers for long-acting implantables, particularly for high-loading, long-duration implants that are gaining interest in the pharmaceutical industry.
VACCINE DEVELOPMENT – COVID-19 Vaccine Focusing on T Cells to Protect the Most Vulnerable
Jeffrey Wolf, MBA, JD, says while most vaccines in development are targeted to protect healthy people, few are focusing on those who are most at risk – seniors and those with co-morbidities like heart failure, obesity, or type 2 diabetes.
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.
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