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.
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.
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.
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
REGISTER TODAY! TWO SESSIONS: March 11, 2021 9:00 AM EST and 1:00 PM EST Join us as we explore the unique challenges in oral delivery of…
ProPerma™ uniquely improves both permeability and bioavailability of BCS III and BCS IV compounds by deploying an innovative and bespoke combination of GRAS and novel enhancing excipients…
Considerations in Support of Achieving Successful Double Blinding and Removing Bias With Over Encapsulation
Download the new whitepaper, Considerations in Support of Achieving Successful Double Blinding and Removing Bias With Over Encapsulation, to learn more about these considerations and…
Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.
Tilman Roedle says variation in tub packaging continues to create financial and operational challenges for the entire downstream supply chain, and it’s time for the industry to align on packaging configuration requirements that make tubs fully processable on automated lines.
FORMULATION DEVELOPMENT – The Role of Excipient Selection in the Development of Orally Disintegrating Tablets
Torkel Gren, PhD, reviews the benefits that orally disintegrating products can bring to patients and developers and assesses the impact that excipient selection can have on the development of successful products.
EXCLUSIVE ONLINE CONTENT
Celon Pharma S.A. recently announced the successful completion of its Phase 1A trial of its JAK/ROCK kinases dual inhibitor, CPL’116. CPL’116 was administered orally in….
Noble Launches Human Factors Engineering Services to Support Product Development and US FDA Approval of Medical Devices & Combination Products
Noble, an Aptar Pharma company and world leader in providing drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, recently announced the launch of Human Factors Plus (HF+), an expanded service to further….
Biogen Announces FDA Approval of PLEGRIDY (Peginterferon Beta-1a) Intramuscular Administration for Multiple Sclerosis
Biogen Inc. recently announced the US FDA has approved a new intramuscular (IM) injection route of administration for PLEGRIDY (peginterferon beta-1a) for the treatment of….
Pacira BioSciences, Inc. recently announced that the company will lead an equity investment in GeneQuine Biotherapeutics GmbH…..
Stevanato Group Launches After-Sales Service Offering for Technologies & Manufacturing Equipment by Establishing a Global Network
Stevanato Group has launched an updated comprehensive, global after-sales service offering for pharmaceutical customers. Effective from January this year,….