MONOCLONAL ANTIBODIES – The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities From Clone to Clinic
Howard L. Levine, PhD, and Brendan R. Cooney, provide a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.
ORALLY INHALED PRODUCTS – Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
Contributor Cindy H. Dubin highlights the techniques various excipient manufacturers are using to develop more innovative and effective ingredients to improve the performance of drug molecules.
Peter Nielsen, MBA, explains how his company’s candidates are differentiated from those in development at other companies by the type of modification to the antisense molecule and the method by which it is conveyed to its target cell.
EXECUTIVE INTERVIEW – NanOlogy: Submicron Particle Platform Transforms Systemic Chemotherapy Into Local Delivery
Marc Iacobucci, Managing Director of NanOlogy, discusses his company’s technology, clinical program, and efforts to transform cancer therapy.
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
In part 1 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, focuses on the macro aspects of the 2017 product approvals.
Boris Stoeber, PhD, Sahan Ranamukha, PhD, and Rory St. Clair describe the Microdermics technology and its improvements over the conventional subcutaneous route of administration.
SPECIAL FEATURE – Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
Susan Rosenbaum, JD, and Irwin Hollander, PhD, present a unique and novel solution to this greatest challenge in medicine for brain disease treatment, considered the “Holy Grail of Neuroscience,” with their breakthrough innovation.
EXCLUSIVE ONLINE CONTENT
CURE Pharmaceutical recently announced it entered into a multi-year licensing agreement for the first time with a leading international cannabis company.
Sol-Gel Technologies Ltd. recently announced it has entered into a collaborative agreement with Perrigo Israel, an affiliate of Perrigo Company plc, for the development, manufacturing, and commercialization of a generic product candidate.
Nevakar Inc. recently announced it entered into an exclusive licensing agreement with Endo International plc’s subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the US and Canada.
Credence MedSystems Closes $12.8-Million Financing to Support Ongoing Development & Scaling of Innovative Delivery Products
Credence MedSystems, Inc., an innovator in injectable drug delivery devices, recently announced the closing of a Series B financing resulting in gross proceeds to the company of $12.8 million.
Croda International Plc and SiSaf Ltd recently announced an exciting new strategic partnership. Croda, the name behind high-performance ingredients and technologies that are relied on by industries and consumers everywhere, has agreed a commercial arrangement with SiSaf, a pioneering UK-based biopharmaceutical company.