Formulation Development
THERAPEUTIC FOCUS – The Future of Treating Alzheimer’s Disease: Aducanumab & Beyond
Hermann Russ, MD, PhD, and Alexander Gebauer, MD, PhD, believe the times when amyloid beta as a drug target have been dubbed a dead horse in the race for treatment of Alzheimer’s disease are now over.
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.
PFS MANUFACTURING – Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery
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.
GENE THERAPY – The Role Viral Vectors Play in Current Gene Therapy Development
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.
FORMULATION DEVELOPMENT – Formulating Immediate-Release Tablets for Poorly Soluble Drugs
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.
FORMULATION FORUM – Rational Design of Oral Nanosuspensions for Insoluble Drugs
Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.
EXECUTIVE INTERVIEW – Adare Pharmaceuticals: A Virtual Acquisition is Possible
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.
EXCLUSIVE ONLINE CONTENT
Aqualung Therapeutics Awarded NIH Fast-Track Award
Aqualung Therapeutics, an early stage biotech company developing an immune-focused, anti-inflammatory therapeutic platform for unchecked inflammation in patients with serious acute and chronic diseases, has been awarded….
Vecture Provides Status Update on Hikma’s ANDA for Generic Advair Diskus VR315 (US)
Vectura Group plc, an industry-leading inhalation CDMO, recently confirmed the announcement made by its partner Hikma Pharmaceuticals PLC, which has received a minor complete response letter (CRL) from the US FDA in….
T-knife & Catalent Sign Technology Transfer & Manufacturing Agreement
T-knife GmbH and Catalent recently announced they have signed an agreement to provide technology transfer and CGMP clinical manufacturing of T-knife’s T1367 T-cell receptor (TCR) program…..
Hovione Announces Partnership to Produce Ligand’s Captisol; Used in Gilead’s Covid-19 Treatment
Hovione recently announced the signing of a partnership agreement with Ligand to significantly ramp up the production output of Captisol, a Ligand product, which is a chemically modified cyclodextrin proven to improve the solubility….
Thomas H. Lee Partners & Frazier Healthcare Partners Acquire Adare
Thomas H. Lee Partners, L.P. and Frazier Healthcare Partners recently announced they have acquired Adare Pharmaceuticals, which will be rebranded Adare Pharma Solutions, a leading specialty contract development….