Featured Articles
EXECUTIVE INTERVIEW - Alcami: Unlocking the Potential of Transformative Medicine for 40 Years
Mike Babics, Vice President, Parenteral Services at Alcami, discusses the company’s recent expansions in formulation and analytical development, manufacturing, release testing, and biostorage of clinical and commercial drug products for both solid dosage and parenteral products.
PLATFORM TECHNOLOGY - Versamune®: A New Generation of Cancer Immunotherapies
Dr. Joe Dervan says the unique ability of Versamune® to modulate and enhance numerous critical steps required for an effective clinically relevant immune response and to be combined with targeted antigens found on tumor cells offers several exciting opportunities to treat a variety of cancers.
FORMULATION FORUM - Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations
Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.
EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics
David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.
MEDICAL DEVICE TESTING - Chemical Characterization & the Non-Targeted Analysis of Medical Devices
Luminita Moraru, MSC, MRSC, says the medical devices industry is in continuous growth, and the development of new reliable and accurate approaches in order to assess the safety of the products should constantly be reviewed.
EXECUTIVE INTERVIEW - Owen Mumford & Stevanato Group: Collaborating to Produce Aidaptus® Auto-injector
Michael Earl, Director of Pharmaceutical Services at Owen Mumford, and Steven Kaufman, Vice President for Drug Delivery Systems at Stevanato Group, discuss their collaboration in producing the innovative Aidaptus auto-injector.
EXCIPIENT COMPACTION STUDY - Developing a Reliable Controlled-Release Polymer Using a Compaction Simulator
Gopeshkumar Singh, MS, and Ajit Bhagat provide study results showing that through polymer chemistry, it is viable to effectively manufacture matrix tablets via a simple direct compression method; and Hypromellose has impressive compatibility at various compression forces.
CLINICAL TRIALS - Quality Matters in an Evolving Clinical Trial Landscape
John Buchan reviews best practices for achieving quality by addressing challenges focused on the all-important but growing complexity of managing the distribution of critical safety documents and the processing of Individual Case Study Reports and aggregate reports to sites, Ethic Committees (ECs), IRBs, and others in the reporting chain.
EXECUTIVE INTERVIEW - Credence MedSystems: Implementing a Flexible Manufacturing Line to Deliver Innovation in Drug Delivery to the Pharmaceutical Industry
Jeffrey Tillack, Chief Operating Officer at Credence MedSystems, discusses the challenges being addressed by his innovative technology and the role its new Flex Line will play in the company’s scaling strategy.
DRUG DISCOVERY - Getting the Most From a DNA-Encoded Library Screen
Matthew A. Clark, PhD, says despite this high level of interest, there remains variable understanding of how to maximize the potential of a DEL screen, and shares his company’s approach to DEL screening and how its partners get the most from this powerful technology.
PLATFORM TECHNOLOGY - The Evolution of Cancer Vaccines: Moving Beyond Failure & a New Era for Cancer Treatment
Jeremy R. Graff, PhD, says new studies show promising data with the use of mRNA-based vaccines and the injection of nanoparticles into regional lymph nodes to achieve disease stabilization. This has led to a potentially groundbreaking era of therapeutic cancer vaccines thanks to discoveries in identifying truncal targets, targeting tumor neoantigens and, notably, developing improved delivery technologies that stimulate a robust, targeted, and persistent immune response.
NANOPARTICLE ENGINEERING - Lighting the Way to a Patient-Centric Future
Christopher Worrall, PhD, discusses how nanoparticle engineering technologies could help improve compliance and patient outcomes, for both small-molecule and biological drugs, and how nanotechnology can help facilitate a shift toward more patient-centric medicine.
TOP SPRAY GRANULATION - POLYOX™: Producing Lightweight Metformin Hydrochloride Extended-Release Tablets for Patient Adherence & Cost-Effective Manufacturing
Atul Lohade, PhD, Vinay Muley, and Tejas Gunjikar, PhD, explain how understanding the challenges associated with developing smaller extended-release tablets, and the excipient-based solutions to these challenges, will empower formulators to develop robust, stable drug formulations with high patient adherence while cutting manufacturing costs.
SPECIAL FEATURE - Injection Devices: Three Trends Influencing Development & Delivery
Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.
SOLUBILITY ENHANCEMENT - How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery
Jessica Mueller-Albers, PhD, Yiming Ma, PhD, Alexander Bernhardt, PhD, and Michael Damm review the use of microparticles for solubility enhancement of oral small molecules and how this approach can address the challenges in pharmaceutical formulations.
GENERATIVE AI TECHNOLOGY - Generative Machine Learning Can Construct Smooth Chemical Search Spaces for Efficient Drug Discovery
Jason Rolfe, PhD, and Ali Saberali, PhD, and Mehran Khodabandeh, MSc, explain how Generative ML promises to efficiently optimize more accurate estimates of binding affinity and other pharmacological properties over the entirety of drug-like chemical space.
GENE THERAPY - Developing Affordable Point of Care CAR-T Therapies: Expanding Efficacy & Impact
Rimas Orentas, PhD, and Boro Dropulić, PhD, MBA, believe the future belongs to those who will be able to innovate rapidly, maintain regulatory confidence, and drive down costs to make CAR-T cell and other engineered cell therapies available to all who would benefit.
EXECUTIVE INTERVIEW - Emergent CDMO: A Molecule-to-Market Partner for Complex Biologics
Bill Hartzel, Senior Vice President and Head of CDMO Business, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
DRUG DEVELOPMENT STRATEGIES - Marrying Target Product Profile, Regulatory & Partnering Strategies for Long-Term Product Success
Chris Rojewski believes given the costs, time, and risks associated with contemporary drug development, it’s time this fundamental aspect of successful development be brought as close to the program as possible — the CDMO tasked with executing drug strategy in the first place.
LIVE BIOTHERAPEUTIC PRODUCTS - Not All Microbiome Approaches Are Created Equal
Duncan Peyton says in comparison with other therapeutic classes, such as antibodies or gene therapy, the progress that has been made with LBPs to date has been rapid, and for the field to maintain this rate of progress and to establish LBPs as a mainstay in the treatment of patients across a variety of diseases, a number of key questions need to be addressed.
