Yvonne Moores believes patient safety narratives are a key element in clinical study reporting and reviews current regulatory requirements regarding safety narratives, a proposed process for their development, and ways to simplify the reporting process.
Niels Düring discusses Gerresheimer’s Plastic Packaging division and the complementary synergies working for a company that also manufactures glass provides.
James Brady, PhD, Karen Donato, PhD, and Krista Steger, PhD, indicate that with unmatched quality, flexibility, and scalability, flow electroporation is a universal, cost-effective platform that supports the full range of biotherapeutic and vaccine development activities.
SPECIAL FEATURE – Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products
Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.
Jingjun (Jim) Huang, PhD, CEO, and Founder of Ascendia, discusses his company’s unique vision and strategy to provide pharmaceutical companies with a contract research partner that can provide technologies in order to efficiently determine which approach is most suitable for a given molecule.
STANDARDIZATION TECHNOLOGY – Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials
Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.
Marshall Crew, PhD, explores how the contract services and manufacturing market has responded to the opportunity presented by the rising numbers of BCS Type II/IV clinical compounds and solubilized commercial products.
Shri Thanedar, PhD, CEO & Chief Chemist at Avomeen Analytical Services, discusses what sets his company’s analytical laboratory apart from other CROs that serve the pharmaceutical industry.
Aish Vivekanandan, Industry Analyst at Frost & Sullivan, reports that in the past several years, it seemed that a cry for regulation of LDTs was falling on deaf years at the FDA. However, after a thorough and intricate letter from the Senate and public outcry for regulations, it seems the FDA is finally taking action.
EXECUTIVE INTERVIEW – Exostar: Speeding the Drug Development & Delivery Process Through Secure Communities of Industry Partners
Drug Development Executive: Tom Johnson, Exostar’s Senior Director of Pharma and Life Science Solutions, discusses how Exostar’s Life Sciences Identity Hub efficiently and cost effectively brings organizations, individuals, applications, and information together to promote the external collaboration initiatives imperative to today’s drug research and development processes.
EXCLUSIVE ONLINE CONTENT
Ajinomoto Bio-Pharma Services recently announce the launch of AJILITY, a flexible and agile drug product manufacturing platform, designed to advance….
Moderna & Catalent Announce Collaboration for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Moderna, Inc. and Catalent, Inc. recently announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate…..
AGTC Announces Significant Productivity & Quality Enhancement to Its Proprietary Manufacturing Process
Applied Genetic Technologies Corporation recently provided an update on the continued productivity and quality improvements made in its proprietary manufacturing platform that is….
The CEOs of Gerresheimer, Stevanato Group, and SCHOTT are committed to ensuring ample supply of pharmaceutical containers for any Covid-19 vaccine and treatment that is developed, and that no patient shall be left….
Catalent, Inc. recently announced that Catalent Biologics will provide vial filling and packaging capacity to AstraZeneca PLC at Catalent’s manufacturing facility….