Formulation Development
COMBINATION PRODUCTS – Development Challenges & Solutions
Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.
EXECUTIVE INTERVIEW – Nuritas Pharma: Life Changing Peptide Drug Discoveries for a Changing World
Nora Khaldi, PhD, Founder and Chief Executive Officer of Nuritas, discusses the company’s innovative approach to accelerating the discovery of novel therapeutic peptides that address unmet patient needs in multiple disease areas.
2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development
This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.
2020 Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases
This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.
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.
EXCLUSIVE ONLINE CONTENT

Nexelis Acquires GSK Vaccines Clinical Bioanalytical Laboratory
Nexelis, a portfolio company of Ampersand Capital Partners, and a leading provider of advanced assay development and laboratory testing services in the infectious, oncologic, and metabolic diseases fields, has signed an asset purchase agreement with GSK to….

ViGeneron Announces Research Collaboration With Daiichi Sankyo to Evaluate Novel Ophthalmic Gene Therapy
ViGeneron GmbH recently announced a research collaboration to utilize its novel engineered adeno-associated virus (vgAAV) vectors with Daiichi Sankyo Company, Limited for delivering….

Molecular Templates Announces FDA Acceptance of IND Application for a PD-L1-Targeted Engineered Toxin Body Enabled With Proprietary Antigen Seeding Technology
Molecular Templates, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for MT-6402, a next-generation ETB targeting PD-L1 that is enabled with….

Clene Nanomedicine Receives Patent Notice of Allowance for using Gold Nanocrystals for Treating MS
Clene Inc. recently announced its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, was issued a Notice of Allowance from the US Patent and Trademark Office (USPTO) for its invention for….

Hovione Launches the Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation
Hovione, the leader in Pharmaceutical Spray Drying, recently announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions…..