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.
Samsung Biologics Announces Strategic Manufacturing Partnership With Lilly to Accelerate Delivery of COVID-19 Antibody Treatments
Samsung Biologics’ partnership with Eli Lilly and Company is expected to greatly accelerate the global supply for Lilly’s COVID-19 antibody therapies through a long-term manufacturing agreement….
Assembly Biosciences & Door Pharmaceuticals Sign Collaboration & Option Agreement
Assembly Biosciences, Inc. and Door Pharmaceuticals, LLC recently announced the companies have signed an exclusive, 2-year collaboration and option agreement focused on the development of….
XOMA Earns $2-Million Milestone From Takeda
XOMA Corporation recently announced it has earned a $2-million milestone payment from Takeda Pharmaceutical Company Limited as the first patient has been dosed….
Albireo Pharma Announces New Phase 3 Data That Shows Durable Response to Odevixibat in a Rare Pediatric Liver Disease
Albireo Pharma, Inc. recently announced new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions in serum bile acids (sBAs) and improvements in…
Beam Therapeutics Presents First Data Highlighting Base Editing Program for Glycogen Storage Disease Type Ia
Beam Therapeutics Inc. recently announced the company will present preclinical data from its liver-focused programs, including the first data highlighting its novel base-editing strategy for…
Cambrex to Invest $50 Million to Expand Multipurpose Large-Scale Manufacturing Capabilities in the US
Cambrex recently announced it is expanding its mid-scale and large-scale API manufacturing capacity in Charles City, Iowa. The $50+ million investment is designed to meet…
CalciMedica Announces Publication of Preclinical Data Demonstrating the Pathological Role of Microglial CRAC Channels in Ischemic Stroke
CalciMedica Inc. recently announced the publication of preclinical data demonstrating a pathological role for CRAC channel-mediated microglial calcium activity in ischemic brain injury in the…
BioAegis Therapeutics Expands Phase 2 COVID-19 Treatment Clinical Trial
BioAegis Therapeutics Inc. recently announced it has expanded its clinical trial in severe COVID-19 to additional sites in Europe. The study has recruited more than…
Apellis Announces FDA Acceptance & Priority Review of NDA
Apellis Pharmaceuticals, Inc. recently announced the US FDA has accepted and granted Priority Review designation for the New Drug Application (NDA) for pegcetacoplan for the treatment…
WHITE PAPER ALERT - Considerations in Support of Achieving Successful Double Blinding and Removing Bias With Over Encapsulation
Despite the relative simplicity of over-encapsulation, proper planning, and careful execution are still fundamental to success — full consideration must be given to every detail from capsule color and size selection to having a well-trained team dedicated to the process…..
Benefits of Small-Scale Drug Development
Kieran Coffey, Technical Lead at Pfizer CentreOne’s Newbridge facility, discusses the benefits of small-scale processing for process development of tablet products.
Atossa Therapeutics Announces Preliminary Results from Phase 1 Clinical Study of Nasal Spray Being Developed for COVID-19
Atossa Therapeutics, Inc. recently announced blinded preliminary results from its Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301…
IntelGenx Announces Issuance of US Patent for Novel Technology Applicable to Cannabis-Containing Oral Films
IntelGenx Corp., a leading oral drug delivery company, recently announced that the United States Patent and Trademark Office has issued US Patent 10,828,254, titled Oral…
XOMA Earns First Milestone Payment From 2018 Royalty Purchase Agreement
XOMA Corporation recently announced it has earned a $1-million milestone payment from Agenus Inc. related to Merck’s advancement of MK-4830 into a Phase 2 study…
Halberd Corporation Files for Patent Protection on Enhanced Nasal Spray to Prevent Covid-19
Halberd Corporation reported the filing of a Covid-19 provisional patent on an enhanced nasal spray. The application, Nasal Spray to Prevent the Transmission of Covid-19,…
