SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
Brian Ogilvie, PhD, and Andrea Wolff explain the implications of the new timing requirements and best practices for negotiating them efficiently and effectively moving forward.
Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.
MARKET BRIEF – Nothing Degrading About Saving Lives: E3 Ligands Recruiting New Drugs Into the Clinic
Marianna Tcherpakov, PhD, discusses underexploited strategies, traditional approaches that can be optimized, novel techniques beginning to emerge and pay dividends, and results propelling this field toward better clinical outcomes.
FORMULATION FORUM – Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development
Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.
EXECUTIVE INTERVIEW – Synteract: Advances in Pediatric Clinical Research & the Promise for the Future
Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract, reviews current and significant challenges in pediatric clinical research, advancement of regulations surrounding them, and where the industry is headed.
In conclusion of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, reviews and compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.
EXCLUSIVE ONLINE CONTENT
Ligand Pharmaceuticals Incorporated and PhoreMost Limited recently announced the signing of a research collaboration agreement between Ligand’s subsidiary Vernalis and PhoreMost on an undisclosed novel oncology target.
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..
DRGT Completes a Pivotal Phase I Trial; Results Confirm 6X Faster Attainment of Maximum Plasma Levels
Druggability Technologies Holdings (DRGT) recently announced results from a pharmacokinetic study of their novel formulation of celecoxib (DRGT-46), which achieves faster time to maximum plasma concentration (Tmax) compared to traditional celecoxib capsules.
Insilico Launches Comprehensive Portfolio of Predictive Digital Twins for Cell Culture Process Development
In close alignment with customer needs Insilico Biotechnology AG has developed a modular suite of Digital Twins that cover key steps during bioprocess development.
Biogen recently announced it has completed its acquisition of Nightstar Therapeutics, a clinical-stage gene therapy company, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders.
Enable Injections, Inc. recently announced it has entered into a multi-product development agreement with Sanofi S.A.
AptarGroup, Inc. recently announced it has acquired two leading pharmaceutical services companies, Nanopharm Ltd. and Gateway Analytical LLC, for a combined enterprise value of approximately $50 million.
PCI Pharma Services Announces Further Expansion to Maintain Industry-Leading Quality, Service, and Flexibility
PCI Pharma Services, a leading biopharmaceutical outsourcing services provider, recently announced the growth of its West Coast Clinical operations with expansion into its third facility in San Diego.
Verseon recently presented a new class of oral candidate drugs, which could not only revolutionize the treatment of diabetic macular edema (DME), but could also be effective in preventing this increasingly common condition.
Cambrex Corporation recently announced it has completed a new facility at its site in Karlskoga, Sweden, which incorporates new laboratories for process and analytical development.