Alex Kerr, Sam Trotter, and Poppy Maley explain how recent advances in biopolymers and manufacturing technology now enable formulation of injectable drug products to be tailored at will to achieve a target bioavailability in a shorter development time with robust and low cost of manufacture.
Contributor Cindy Dubin speaks with several innovative excipient companies that assert novel excipients – agglomerated, co-processed, and multifunctional – actively and safely affect formulation stability, solubility, and bioavailability as well as foster faster drug disintegration.
GLOBAL REPORT – 2020 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery and Formulation Product Approvals of 2020
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.
Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.
BIOSIMILAR DEVELOPMENT – Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices
Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.
Keith R. Horspool, PhD, Shirlynn Chen, PhD, and Markus Koester, PhD, discuss an open innovation platform to stimulate scientific understanding, and development of potential new technologies, for delivery of compounds with challenging solubility by offering a set of more contemporary poorly soluble drugs free-of-charge for independent research activities.
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.
Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business, discusses her company’s drug delivery platform and the value it brings to the industry.
NUCLEAR β-CATENIN INHIBITOR – TBL1 – A Novel Target for Safe & Effective Blockade of the Nuclear β-catenin Signaling Pathway
Ruolan Han, PhD, explains how targeting TBL1/TBLR1 enables specific silencing of oncogenic Wnt target gene expression without affecting other necessary cellular functions that are disrupted when targeting higher up the Wnt pathway.
Jennifer Rogers discusses how non-fatal recurring events, such as asthma attacks, epileptic seizures, and hospitalization for heart disease, have a certain manner in which they should be handled in clinical trials.
David J. Bearss, PhD, Chief Scientific Officer and Global Head of Research at SDP Oncology, discusses his company’s unique structure that has supported its robust research in the tumor immune microenvironment as well as its investigational assets being studied in this space.
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.
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2020 product approvals.
The Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
With the development of ILC Dover’s new Aseptic Isolator system new opportunities have opened up for many organizations who were previously able to conduct fill finish activities due to facility restraints or expensive closed barrier systems. This new technology….
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Outsourcing Drug Development & Production: Technology-Driven Drug Delivery Systems for Small Molecules at Losan Pharma
Due to the increasing demand for drug delivery systems that are able to improve the properties of low soluble, poor permeable, or highly dosed new and existing drug substances, technology-driven CDMOs can offer a wide range of technology platforms to overcome such challenges….
In this Whitepaper, Solo Containment (now part of ILC Dover) walks you through their process, from concept-to-development, for creating a fully disposable Grade-A aseptic fill/finish isolation system.
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…
Developing a new pharmaceutical product is one of the most interesting and rewarding activities to partake in, it is also extremely challenging. It is a given that drug development projects will not….
EXCLUSIVE ONLINE CONTENT
Context Therapeutics and Integral Molecular recently announced a research collaboration and licensing agreement for the development of an anti-claudin 6 (CLDN6) bispecific monoclonal antibody….
AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis
AzurRx BioPharma, Inc. recently announced it has entered into an agreement with PPD, Inc. for its planned Phase 1b/2a clinical trial evaluating proprietary formulations of micronized….
SOTIO Demonstrates Strong Potential of SOT102 (ADC Targeting Claudin 18.2) for Treatment of Solid Tumors in Preclinical Studies
SOTIO recently announced new preclinical data of its antibody-drug conjugate (ADC), SOT102 (formerly SO-N102), for the treatment of solid tumors in a virtual….
Artelo Biosciences Doses First Patient in CAReS Study for the Treatment of Cancer-Related Anorexia & Weight Loss
Artelo Biosciences, Inc. recently announced the first patient has been dosed in the company’s Phase 1/2 Cancer Appetite Recovery Study (CAReS) of ART27.13….
I-Mab & ABL Bio Announce First Patient Dosed in Phase 1 Trial of Bispecific Antibody TJ-L14B/ABL503 in Patients With Advanced or Metastatic Solid Tumors
I-Mab and ABL Bio, Inc. recently announced the first patient has been dosed in a Phase 1 trial for bispecific antibody TJ-L14B/ABL503. The Phase 1 clinical trial is an open-label….
Cidara Therapeutics Announces Agreement With Janssen to Develop & Commercialize AVCs for the Prevention & Treatment of Influenza
Cidara Therapeutics, Inc. recently announced it has entered into an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. to develop and commercialize….
Progenity & Ionis Pharmaceuticals Enter Agreement to Evaluate Progenity’s Ingestible Oral Biotherapeutics Technology for Delivery of Antisense Therapies
Progenity, Inc. recently announced an agreement with Ionis Pharmaceuticals to evaluate the safety, tolerability, and performance of Progenity’s Oral Biotherapeutics Delivery System (OBDS) for oral systemic delivery of….
Moderna & Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna’s COVID-19 Vaccine & Clinical Portfolio
Moderna, Inc. and Catalent, Inc. recently announced the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other….
Ascendia Pharmaceuticals, Inc. is a specialty CDMO dedicated to developing and manufacturing enhanced formulations for pre-clinical, clinical-stage drug candidates, and marketed drug products. The investment was made by Signet Healthcare Partners….
Tarsus Pharmaceuticals, Inc. and LianBio recently announced a strategic partnership to develop and commercialize TP-03 in Greater China (mainland China, Hong Kong, Taiwan, and Macau)…..