AUTOLOGOUS CELL THERAPIES - Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success April 30, 2013

Ronnda L. Bartel, PhD, Tod Borton, and Brian S. Hampson review how Aastrom Biosciences has developed the innovative processes necessary to reduce risk throughout the manufacturing process. The company is now preparing for future commercialization for its investigational therapy derived from a patient’s own bone marrow stem cells.

Pluri Launches Novel Immunotherapy Platform for Solid Tumor Treatment May 2, 2024

SPECIAL FEATURE - Prefilled Syringes & Parenteral Delivery: Next-Gen Injections Feature Technology & Reconstitution April 30, 2024

Contributor Cindy H. Dubin highlights innovations from key players in parenteral delivery and prefilled syringes, with focuses on safety, meeting regulatory requirements, cost, fill/finish, and dosing.

SCALING MANUFACTURING - Collaboration Between a Device Supplier & Equipment Manufacturer to Meet the Needs of Patients, End-Users & Pharma Manufacturers April 30, 2024

John Merhige and William (“Bill”) Jaworski present how their two companies have worked closely together, using creative manufacturing strategies to produce a wide array of problem-solving drug delivery systems.

FORMULATION DEVELOPMENT - The Rising Need for an Integrated Approach to Small Molecules Drug Development April 29, 2024

Julian Northen, PhD, believes as the demands of a changing society evolve and continue to act as a driver for the identification of novel small molecules, the roles and diversity of the available medicines will also change.

SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024

Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.

DRUG DELIVERY PLATFORM - VitalDose® EVA Implants for Systemic & Local Delivery of Therapeutics March 28, 2024

Cyonna Holmes, PhD, Karen Chen, MS, and Brian Duke explain how systemic delivery approaches that leverage continuous dosing can address adherence issues and improve drug effectiveness while minimizing adverse reactions, and how a localized delivery approach can minimize total drug exposure, reduce off-target toxicities, and overcome targeting issues.

Nykode Therapeutics Announces Topline Conclusions Affirming Prolonged Clinical Benefits From Matured Survival Data in Phase 2 C-02 Trial in Advanced Cervical Cancer March 21, 2024

PREFILLED SYRINGES - Making a Prefilled Syringe Smart: Technological Solutions to Advance Patient Care & Clinical Trial Outcomes February 29, 2024

Salvatore Forte, MS, believes adherence to the dosing regimen, as well as compliance to the injection protocol, are essential for treatment success in both these use-cases. Hence, the request for a connected, smart PFS is growing just as much to tackle poor medication adherence and compliance issues.

DRUG DISCOVERY - Benefits of Acoustic Liquid Handling in Drug Discovery February 29, 2024

John Fuller, PhD, believes automated acoustic liquid dispensing technology is a game changer – whether deployed as a stand-alone instrument, in a scaled-up workstation, or as part of fully integrated systems – when it comes to handling complexity in efficient and cost-effective ways.

SPECIAL FEATURE - Outsourcing Analytical Testing: AI Could Transform Analytical Labs January 29, 2024

Contributor Cindy H. Dubin presents how today’s leading analytical testing service providers are taking advantage of AI and other types of automation and innovative technologies.

PHARMACEUTICAL GLOBALIZATION - Navigating Opportunities & Obstacles December 4, 2023

Jürgen Hönig says rapid globalization of the pharmaceutical industry has created new complexities as companies navigate different regulations and government policies, but there are many reasons for optimism, including harmonization, collaboration, and convergence.

IMUNON Announces First Patient Enrolled in Phase 1/2 Clinical Trial of IMNN-001 in Combination With Bevacizumab in Advanced Ovarian Cancer October 18, 2023

AviadoBio Announces Initiation of Phase 1/2 Clinical Trial Evaluating AVB-101 in People With Frontotemporal Dementia With GRN Mutations October 10, 2023

PLACENTA-ON-A-CHIP - The Future of Drug Discovery In Women’s Health September 29, 2023

Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.

KBI Biopharma Expands Global Portfolio With Launch of SUREmAb for Faster Monoclonal Antibody Development & Manufacturing September 12, 2023

SUPPLY CHAIN SOLUTIONS - Steady Supply in Turbulent Times: The Importance of Secure Supply Chains & Drug Packaging Integrity September 5, 2023

Peter Belden offers unique insight into strategies that can be applied to weather the turbulent times ahead and ensure a reliable supply of critical drug products to patients, and explores how sustainability and integrity can be attained with the right packaging and supply chain solutions.

Zevra Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio & Adding Commercial Product August 31, 2023

Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra’s purchase of Acer’s secured debt in capital efficient structure….

2023 Analytical Testing eBook – Analytical Testing Evolves With the Pharma Industry August 14, 2023

In this fourth annual Analytical Testing e-book, learn more about Alcami, Stevanati Group, and West and their current contributions and offerings in the outsourcing analytical testing market, as it continues to be a time and money saver for bio/pharma companies.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First June 5, 2023

Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.