SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.
Dieter Lingelbach, MBA, discusses the history and science of viral vectors, their current applications, and why they are a vital component in contemporary gene therapy development.
FORMULATION FORUM – Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.
CHIMERIC COMPOUNDS – “Dopastatins”: One Molecule Targeting Two Receptors for the Treatment of Pituitary Tumors
Heather Halem, PhD, and Michael D. Culler, PhD, believe this novel class of compounds represents a potential treatment for neuroendocrine tumors that are vulnerable to the synergistic dual activation of somatostatin and dopamine receptors.
NEXT-GENERATION TUMOR TARGETING – Leveraging the Tumor Microenvironment to Change the Standard of Care
Vishwas Paralkar, PhD, highlights a unique platform technology that represents the first technology that has successfully been used to target cancer drugs to tumor cells in animal models, while sparing healthy tissue.
Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.
Ajay Damani, VP of Pharmaceutical Technologies Business Unit, Adare, and Maria Flynn, President and CEO, Orbis, discuss how both companies will benefit from the acquisition, future product development, and the challenges of a virtual acquisition.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline
In part 4 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, analyzes the pipeline with an emphasis on clinical-stage products for which there is more product-related information.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions
Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.
Patient centricity has moved to the forefront of clinical trials. Direct-to-patient (DTP) services provide convenience, and lead to greater participation and retention, addressing two key challenges that face study sponsors Yourway has.
EXCLUSIVE ONLINE CONTENT
Wondering if investing in a higher purity excipient is really going to pay off? Check out our video web series where we speak to 3 subject matter experts on the benefits of…..
Evonik Launches Platform of Custom Functional Excipients to Precisely Control the Release Profile of Parenteral Drug Products
Evonik recently announced the launch of the RESOMER Precise platform of custom functional polymeric excipients to allow pharmaceutical companies to control…
Junshi Biosciences and Merck recently announced their collaboration on a clinical trial program designed to investigate the efficacy and safety of…
Thermo Fisher Scientific Inc. and CSL Limited recently announced they have entered into a strategic partnership to help meet the growing demand for biologic therapies while also….
NOVA Thin Film Pharmaceuticals & Quality Chemical Laboratories Announce Partnership in Formation & Commencement of Soluble Thin Film Operations
NOVA Thin Film Pharmaceuticals LLC (NTFP) recently announced its formation and the commencement of its soluble thin film operations……
WEBINAR ALERT- From Diluent to Differentiator: How to Choose a Diluent System That Differentiates Your Lyophilized Product
Along with a rapidly expanding global market for innovative lyophilized biologics come increased cost and competitive pressures. Today, it is critical that….
Apollomics, Inc. recent announced the initiation of the Phase 2 portion of the Phase 1/2 clinical trial for APL-101 based on completion of the Phase 1 and approval from the….
The US FDA has recently approved the investigational new drug (IND) application submitted by Octapharma USA for a Phase 3 clinical trial on…
SeraNovo B.V. recently announced it has signed a second License Agreement with Carna Biosciences, Inc., a company engaged in the drug development of….
CanSino Biologics & Precision NanoSystems Announce Collaboration to Co-Develop a COVID-19 RNA Vaccine
CanSino Biologics Inc. and Precision NanoSystems (PNI) recently announced a co-development agreement of a mRNA lipid nanoparticle (mRNA-LNP) vaccine against COVID-19. The parties will…