SPECIAL FEATURE – Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.
Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.
Tilman Roedle says variation in tub packaging continues to create financial and operational challenges for the entire downstream supply chain, and it’s time for the industry to align on packaging configuration requirements that make tubs fully processable on automated lines.
MULTI-PARTICULATE MANUFACTURING – How Does Experiment Design Affect Multi-Particulates Manufacturing?
Namrata Vora, MS, Danica Cartwright, Karthikeyan Selvaraj, MPharm, and Ryan Larmon, MS, discuss how the careful application of design of experiment studies is an invaluable tool in proving the design space of complex formulations and manufacturing processes.
Richard Vellacott, CEO of BiologIC Technologies, discusses his company’s unique technology and its applications in the future of medicine and wider fields of synthetic biology.
FORMULATION DEVELOPMENT – The Role of Excipient Selection in the Development of Orally Disintegrating Tablets
Torkel Gren, PhD, reviews the benefits that orally disintegrating products can bring to patients and developers and assesses the impact that excipient selection can have on the development of successful products.
Lindsay A. Rosenwald, MD, Chairman, President, and CEO of Fortress Biotech, discusses how his medical and financial knowledge come together to find successful drug candidates, the company’s partnership model, and the inefficiencies he sees in the biotech industry.
TURNAROUND CASE STUDY – A Pharma Industry Outsider’s Perspective – Turning Around the “ABCDMO” Company
Paul Fioravanti, MBA, MPA, presents a case study on how he successfully turned around a failing CDMO that grew rapidly from one production location to eight in just 4 years, but was just few weeks away from running out of cash.
BIOSIMILAR DEVELOPMENT – Biosimilars: The Process & Quality System Approach to Clinical Applications
Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.
Roger Humphrey, MBA, says a new era of deal-making is accelerating breakthrough therapy development, making now a prime time to look for breakthrough real estate and facilities concepts as well.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
PLATFORM TECHNOLOGY – Overcoming the Challenges of Drug Brain Delivery With a Novel Brain Delivery Vector
Mei Mei Tian, PhD, explains how the xB3 platform has the potential to support development of treatments for CNS diseases that can treat thousands of patients in the years ahead.
POLYMERIC DELIVERY SYSTEM – Next-Generation Long-Acting Implantables Using Surface-Eroding Elastomers
Stephanie Reed, PhD, Carissa Smoot, and Dennis Shull describe how PGSU ultimately offers many advantages over other polymers for long-acting implantables, particularly for high-loading, long-duration implants that are gaining interest in the pharmaceutical industry.
Jeffrey Wolf, MBA, JD, says while most vaccines in development are targeted to protect healthy people, few are focusing on those who are most at risk – seniors and those with co-morbidities like heart failure, obesity, or type 2 diabetes.
EXCLUSIVE ONLINE CONTENT
Credence MedSystems recently announced that Novartis has made a strategic investment in the company. The investment will advance ongoing development and scaling of Credence’s innovative drug delivery systems….
Nexelis, a portfolio company of Ampersand Capital Partners, and a leading provider of advanced assay development and laboratory testing services in the infectious, oncologic, and metabolic diseases fields, has signed an asset purchase agreement with GSK to….
ViGeneron Announces Research Collaboration With Daiichi Sankyo to Evaluate Novel Ophthalmic Gene Therapy
ViGeneron GmbH recently announced a research collaboration to utilize its novel engineered adeno-associated virus (vgAAV) vectors with Daiichi Sankyo Company, Limited for delivering….
Molecular Templates Announces FDA Acceptance of IND Application for a PD-L1-Targeted Engineered Toxin Body Enabled With Proprietary Antigen Seeding Technology
Molecular Templates, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for MT-6402, a next-generation ETB targeting PD-L1 that is enabled with….
Clene Inc. recently announced its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, was issued a Notice of Allowance from the US Patent and Trademark Office (USPTO) for its invention for….
In the process of aseptic manufacturing of prefilled drug delivery systems, the main goal is the prevention of any contamination of the final product. The best course of action is the….
Hovione Launches the Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation
Hovione, the leader in Pharmaceutical Spray Drying, recently announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions…..
BD Advances Immunology Research by Enabling Researchers to Investigate 30 Immune Markers in a Single Experiment
BD (Becton, Dickinson and Company) recently announced the commercial release of the BD AbSeq Immune Discovery Panel (IDP), a state-of-the-art, pre-titrated antibody-oligo-based discovery tool designed to….
Baxter International Inc. recently announced that Baxter BioPharma Solutions has entered into an agreement to provide sterile manufacturing services for NVX-CoV2373, Novavax’s COVID-19 recombinant nanoparticle….
Through this recent license agreement, SIRION Biotech GmbH has granted Cellectis non-exclusive right under its proprietary lentiviral transduction….