FORMULATION FORUM - Rational Design & Development of Long-Acting Injectable Dosage Forms
Due to the advantages of parenteral sustained-release drug delivery (also known as long-acting injectables, LAIs) different types of sustained-release injectable delivery systems have been….
SPECIAL FEATURE - Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
AUTOINJECTOR PLATFORM - Identifying New, Enhanced Device Delivery Solutions for Chronic Diseases
Karima Yadi, MSc, and Lionel Maritan, MSc, believe identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.
PERSONALIZED MEDICINE - Personalizing Cancer Immunotherapy: Trends in Biomarker Discovery
Emile Youssef, MD, PhD, says due to tumor heterogeneity, the plasticity and diversity of cancer cells, and a multitude of other factors, biomarker development is a challenge, and thus explores four trends in cancer biomarker discovery.
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 1
Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
IMAGE-BASED CHARACTERIZATION - Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
BIOPROCESSING - A New Era: Why the Time Has Come for Biopharma to Move to Continuous Bioprocessing
Dr. Martin Smith explains why the pharma industry must embrace continuous processing if it’s to survive and thrive in an era of global personalized medicine.
CYBERSECURITY - Why Pharmaceutical Companies Are Vulnerable to Cyberattacks & What You Can Do to Protect Your Company
Andrew Douthwaite says having a comprehensive cybersecurity strategy in place to safeguard digital assets has become an essential part of any company’s security protocols, and not doing so leaves valuable data vulnerable.
EXECUTIVE INTERVIEW - Foamix Pharmaceuticals: Delivering Pharmaceuticals to the Skin Through a Foam
David Domzalski, Chief Executive Officer of Foamix, discusses his company’s innovative approach to drug delivery using foam to treat dermatological conditions, like acne and rosacea.
OLIGONUCLEOTIDE DELIVERY - Dectin-1 Receptor-Mediated Delivery of Oligonucleotide Drugs Complexed With Schizophyllan Dendritic Cells & Macrophages
Kenji Arima, PhD, and Akihiko Watanabe, PhD, introduce NapaJen Pharma’s technology with a specific focus on solving some of the current challenges of oligonucleotide therapeutics.
MARKET BRIEF - Tumor-Infiltrating Lymphocytes: A New Frontier in Cancer Immunotherapy
Cheryl L. Barton, PhD, and Bianca Piachaud-Moustakis, PhD, believe the role of TIL therapy as an anticancer therapy in melanoma and possibly other solid tumors holds great promise and could become a viable course of treatment in the future.
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
CDMO SELECTION - Ready to Launch: Developing Your Biologic With an Eye Toward Commercial Supply
Stacey Treichler, PhD, believes the development process for new biologics is complex and requires a substantial amount of time and resources, and reviews some of the areas where careful choice of CDMO is key, including cell line development and cGMP manufacturing capabilities, and how an integrated approach can be beneficial.
PREFILLED SYRINGES - Selecting the Right Primary Container for Injectables in Acute Care
Alfred Harvey, MBA, MS, discusses how differences in primary container options for injectable drugs can add value by offering hospitals and care centers configurations that address universal pain points.
CONTINUOUS MANUFACTURING - Continuous Manufacturing in Pharmaceuticals: Implications for the Generics Market
Kamna Jhamb, PhD, says the highly regulated nature of the pharmaceutical sector, and the low-risk-taking nature of this market, are the two main factors that have restrained the implementation of novel methods of manufacturing by pharmaceutical industries. However, the burgeoning demand for complex and innovative therapies and rising competition have led pharmaceutical manufacturers to reconsider their methods of manufacturing.
DRUG DEVELOPMENT EXECUTIVE - ProQR: Developing RNA Therapies for Rare Genetic Disorders
Daniel de Boer, Chief Executive Officer of ProQR, discusses the use of RNA technology to directly target the underlying cause of genetic diseases.
MODIFIED RELEASE - Alternative Strategies for Development of Modified-Release Dosage Forms
Andy Lewis, PhD, discusses a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing.
COMBINATION PRODUCT DEVELOPMENT - New Horizons in Development to Meet Emerging Demands
Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.
CHARACTERIZATION CORNER - A New Weapon in Formulation Development
Matt McGann explains how Microfluidic Modulation Spectroscopy is the final addition in the biophysical characterization scientist’s toolkit.
MICROFLUIDIC ENCAPSULATION - Controlling Drug Delivery With PLGA
Richard Gray, MA, discusses the use of polymer microparticles for pharmaceutical applications, including specific examples of polylactic-co-glycolic acid (PLGA) encapsulation.
