Formulation Development
NGM Bio Initiates Expansion of Ongoing Phase 1b Proof-of-Concept Study
NGM Biopharmaceuticals, Inc. recently announced it has dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients…
Aptamer Group Extends Collaboration With AstraZeneca to Explore Next-Generation Drug Delivery Approaches
Aptamer Group, the developer of Optimer reagents and therapeutics, recently announced the extension of its current agreement with AstraZeneca, a global biopharmaceutical company. This agreement…
SPECIAL FEATURE - Improving Bioavailability & Solubility: Each Molecule Is Unique
Contributor Cindy H. Dubin speaks with several innovative companies to discuss novel approaches to improving bioavailability and solubility that have one commonality: they treat each molecule as an individual.
FORMULATION FORUM - Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
GLOBAL REPORT - 2020 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 2020 product approvals.
CELL & GENE THERAPY - End-to-End Cell & Gene Therapy – From Development to Commercialization – Buy or Build?
Aldo Romano and Emily Moran, MBA, discuss how the life science industry must bring technology solutions to the table while at the same time securing the capacity to develop and manufacture groundbreaking cures so patients and society can tap the benefits of cell and gene therapies.
DRUG DEVELOPMENT - Understanding & Targeting the Mechanism of Action of Developmental Disorders
Michael Snape, PhD, says when identifying promising therapeutic targets for any disease or condition, including developmental disorders such as Fragile X syndrome, PMS, CDM1, and Rett syndrome, it is critical researchers work to understand the mechanism of disease and disease pathways as well as the unmet need and patient experience.
EXECUTIVE INTERVIEW - Pharmaceutics International, Inc: Getting Back to its Roots
Sridhar Krishnan, Pii’s Senior Vice President, Operations and Strategic Initiatives, discusses how manufacturing is not solely where Pii wanted to be, so the company made a concerted effort to get back to its CDMO roots.
IMMUNE ACTIVATORS - Enhancing Cell Adhesion to Safely Improve Effectiveness of Vaccines & Cancer Immunotherapies
Siddhartha De, PhD, and Peter Vanderslice, PhD, present their research on the use of proprietary, orally available compounds that can activate the immune system to enhance the effectiveness of vaccines as well as immuno-oncology therapies for cancer, especially in patient populations that are most vulnerable to disease.
MICROFLUIDIC ENCAPSULATION TECHNOLOGY - Achieving Reliable siRNA Drug Delivery for Inflammatory Diseases & Tumor Targeting by Nanoencapsulation
Olivia Merkel, PhD, and Christoph Zimmermann, PhD student, discuss the benefits of microfluidic encapsulation technology for gene silencing applications in cancer immunology and inflammatory diseases, where siRNA can potentially be used to downregulate genes associated with these pathologies.
EXECUTIVE INTERVIEW - Pace Analytical® Life Sciences: Delivering Science Better; Advancing Novel Therapies Through the Clinic to Commercialization
Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at PLS, discusses his experiences with the company and its recent growth.
ORAL MUCOSAL IMMUNOTHERAPY - Oral Mucosal Delivery of Allergenic Proteins for Inducing Tolerance in Food Allergic Individuals
William R. Reisacher, MD, highlights some of the differences between food allergy immunotherapy via the oral mucosal route versus exposure through the stomach and intestines.
AMRI Joins Network of Approved Manufacturers of Lipid Excipients for Pfizer-BioNTech COVID-19 Vaccine
Albany Molecular Research, Inc. recently announced that the company has been chosen to support the development and manufacture of lipid excipients for the Pfizer-BioNTech COVID-19 vaccine.…
Vaccinex Announces Signing of Two Multi-Project Deals With Leading Pharmaceutical Companies
Vaccinex, Inc. recently announced the signing of multi-project deals with two undisclosed prominent pharmaceutical companies…..
SIRION Biotech & Sanofi Join Forces to Develop Gene Therapies for Multiple Life-Threatening Disorders
SIRION Biotech GmbH recently announced it signed a license and collaboration agreement with Sanofi to develop improved tissue-selective adeno-associated virus (AAV) vectors to realize….
Catalent to Acquire Delphi Genetics & Launch US Plasmid Manufacturing Site to Establish Global pDNA Development & Manufacturing Capabilities
Catalent and Delphi Genetics recently announced they have entered into a final and definitive agreement whereby Catalent will acquire 100% of the shares of Delphi Genetics. Catalent is also….
Halberd Collaborates With GreenBioAZ for the Development of Its Patent Pending Radio Frequency Technology
Halberd Corporation has engaged GreenBioAZ, Inc. to conduct laboratory testing of Halberd’s patent-pending Radio Frequency (RF) extracorporeal treatment to eliminate infectious disease pathogens. The methodology…
Intra-Cellular Therapies Applies for FDA Approval of Bipolar Depression Treatment
Intra-Cellular Therapies, Inc. recently announced it has submitted supplemental New Drug Applications (sNDAs) to the US FDA for two indications for CAPLYTA (lumateperone): 1) as…
Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer
Celsion Corporation recently announced that it has received Fast Track designation from the US FDA for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase…
Catalent Announces Commercial Supply Agreement With Aurinia Pharmaceuticals
Catalent recently announced it recently signed a multi-year commercial supply agreement with Aurinia Pharmaceuticals, a biopharmaceutical company focused on delivering therapies to treat targeted patient…
