This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
SPECIAL FEATURE – Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
Jim Huang, PhD, and Shaukat Ali, PhD, explain how their company is expanding its footprints in sterile manufacturing to handle innovative molecules and leverage its services to emerging and specialty and biopharma companies requiring cGMP materials for preclinical tox and clinical studies.
Tom Quinci, MSc, believes oncology requires new treatment modalities that are better for patients, and it is time technologies like drug-eluting implants, offering real, achievable advantages, are more widely considered.
Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.
FUNCTIONAL EXCIPIENTS – Improving the Water Solubility of Oral Drugs With Amorphous Solid Dispersions (ASDs)
Liliana Miinea, PhD, says with certain polymers, it is possible for drug formulators to take full advantage of the benefits of ASDs, enabling them to overcome formulation challenges to deliver more effective novel drug products capable of transforming the lives of patients.
CLINICAL TRIALS – Historical Controls in Rare Disease Drug Development: Using RWE to Overcome Key Challenges
William Maier, MD, PhD, says the utility of HCs based on RWE should be evaluated for potential applications to increase speed of product approval, reimbursement, and clinical practice adoption.
Bob Lechleider, MD, explains how by applying a patient-first technology and looking for clues in the immune system, a powerful tool can be harnessed – the human body – to identify and produce new molecules to make medicines for cancer patients.
EXECUTIVE INTERVIEW – TC BioPharm: Developing Platform Allogeneic Gamma-Delta T Cell Therapies for Cancer
Bryan Kobel, CEO of TC BioPharm, discusses his company’s upcoming plans, therapeutic clinical trials, and the biotech landscape.
Gerry McNally, PhD, says there are many misconceptions when it comes to considering the best way or format to consume CBD and get the maximum benefit. Formulation scientists need to consider several factors when developing new formulations of nutraceutical ingredients, especially botanical ingredients and natural materials from various sources.
EXCLUSIVE ONLINE CONTENT
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.