Formulation Development
ANTIBODY THERAPEUTICS - Teneobio’s Next Generation of Multispecific Antibody Therapeutics
Omid Vafa, PhD, MBA, reviews unique technologies, including a transgenic rat platform expressing human heavy chain antibodies, and a state-of-the-art sequence-based discovery engine, to create novel multispecific antibodies for various therapeutic indications.
PACKAGING - Child-Resistant Features for Container Closure Systems
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
NEXT-GENERATION SEQUENCING - Emerging Clinical Applications & Projections to 2022
Laurie L. Sullivan and John Bergin, MS, MBA, say the growth curve for clinical applications of NGS is approaching an upward trajectory as existing applications gain traction and new ones begin to establish a foothold.
CANCER IMMUNOTHERAPY - Building on Initial Successes to Improve Clinical Outcomes
Allan B. Haberman, PhD, provides an updated discussion of approved and clinical-stage agents in immuno-oncology, including recently approved agents. He also addresses how researchers and companies are attempting to build on prior achievements in immuno-oncology to improve outcomes for more patients.
EXECUTIVE INTERVIEW - Lonza Pharma & Biotech: Taking on the Next Challenges in Small Molecules
Gordon Bates, Head of Chemical Division at Lonza Pharma & Biotech, shares his perspective about industry needs and how strategic acquisitions are enhancing Lonza’s position as a development and manufacturing partner of choice.
TABLET FORMULATION - Reformulation of Tablets to Resolve Sticking & Picking Issues Faced on Compression: A Case Study
Smruti P. Chaudhari, PhD, and Anshul Gupte, PhD, successfully reformulated tablets using the potassium-salt form of Compound XY without adding any new excipient. Through the reformulation, they also resolved earlier issues faced during tablet compression.
GENE & CELL THERAPY - Its Growing Potential to Disrupt Drug Research & Healthcare Delivery
Jeff Galvin believes as the pace of gene and cell therapies accelerates over this next decade, potential cures for chronic diseases, cancer cures, and autosomal defect cures will result, and the efficacy of new therapeutics may move as much as $500 billion from traditional pharmaceuticals to gene technologies.
LIPID-BASED DELIVERY - Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox?
Jason M. LePree, RPh, PhD, reviews the causes of poor bioavailability for drugs and provides an introduction to lipid-based drug delivery systems, and how the formulation approach can be used to overcome impediments to good bioavailability of therapeutic actives.
EXECUTIVE INTERVIEW - Particle Sciences: Experts in Development & Manufacturing of Complex Dosage Forms
Dr. Mark Mitchnick, CEO of Particle Sciences and CMO of Lubrizol, discusses the rise of complex drug products, the capabilities needed to develop and manufacture these products, and the company’s expansion in this area.
SPECIAL FEATURE - Platform Technologies - Derisking & Transforming Drug Development
Contributor Cindy H. Dubin, in this second annual report, speaks with several exciting and innovative companies whose platform technologies are transforming drug development.
SPECIAL FEATURE - Injectable Drug Delivery: New Technologies Deliver Biologics & Differentiate Brands
Contributor Cindy H. Dubin reports on a segment of the drug delivery industry that will see its market revenue double in just 5 years in response to a growing need to deliver highly viscous, high-volume drugs.
2017 GLOBAL DRUG DELIVERY & FORMULATION REPORT - Notable Technologies, Approvals, Transactions, Pipelines & Perspectives
This third annual report, a collaborative effort between team members at Drug Development & Delivery and PharmaCircle, provides a look back at 2016 in terms of approvals and developments in the area of drug delivery and formulation. The report continues to cover the following significant key points of interest, with the belief that understanding the past, even the recent past, can provide insights to what is possible.
NANOPARTICLES - A Revolution in the Development of Drug Delivery Vehicles
Tim Leaver explains how his company has developed a proprietary technology for the rapid development of nanoparticles and seamless scale-up for clinical studies and commercial production, and how it is transforming the development and manufacturing of a range of nanoparticle formulations from a hit-and-miss affair to a standardized process, accelerating novel nanomedicines from the bench to the clinic.
SPECIAL FEATURE - Wanted: New Excipients to Meet the Demands of a Challenging Industry
Contributor Cindy H. Dubin recently spoke with some of the leading excipient innovators to find out what types of excipients they are developing, the advantages they offer to formulations, and where they see the industry focusing throughout the next few years.
SPRAY-DRIED DISPERSIONS - Particle Engineering of Spray Dried Dispersions: Considerations for Downstream Processing
Aaron Goodwin, PhD, Alyssa Ekdahl, and Deanna Mudie, PhD, demonstrate the tunability of SDD particle properties and the resulting impact on the powder flow and mechanical properties for tablet manufacturability of a given SDD formulation.
LYOPHILIZATION - Lyophilization Cycle Development: Lessons Learned & Pitfalls to Avoid
John W. Burke, MS, says that success in lyophilization transfer and scale-up projects depends on a structured approach to information sharing between a pharma company and its CDMO partner, and should include extensive details about the APIs or bulk drug substance characteristics and planned development and clinical programs.
MDI CHARACTERIZATION - Closing the Gap Between In Vitro Test Data & the In-Use Performance for Metered Dose Inhalers
David A. Lewis, PhD, presents experimental data that shows how certain modifications to the Pharmacopoeial test methods used for MDIs may result in data that is more indicative of real-life performance, providing insight that can be used to enhance drug delivery characteristics.
EXECUTIVE INTERVIEW - Pfizer CentreOne: The Value of the Embedded-CMO Model
Peter Stevenson, Vice President and General Manager of Pfizer CentreOne, discusses the value and significance of the embedded-CMO model in the biopharmaceutical industry.
EXCIPIENT UPDATE - Solvent-Less Film Coatings: New Ethylcellulose Grade Enables Rapid Dry Powder Coating
Nick Grasman and Paula Garcia Todd, MS, present ETHOCEL HP as an innovative new product that helps customers increase productivity while still maintaining the advantages of Dow manufactured ETHOCEL, such as tight viscosity, narrow ethoxyl distribution, and reduced fiber content.
CONTROLLED RELEASE - Leveraging Precision Particle Fabrication® Technology to Create Patient-Friendly Dosage Forms
Cory Berkland, PhD, and Nathan Dormer, PhD, review how controlled-release powders offer a flexible and efficient approach to addressing a multitude of patient populations, while also improving compliance.
