Featured Articles
BUSINESS DEVELOPMENT- The Performance Report
John A. Bermingham says a performance report should be a document in which you and the person you are reviewing take the opportunity to talk about that person’s job performance not just from your perspective but from the reviewee’s perspective.
CELL CULTURE MEDIA - Addressing Variability in Dry Powder Mammalian Cell Culture Media
Jörg von Hagen, PhD, believes it is critical for media manufacturers to have a process in place that can consistently deliver raw material and process quality to be able to deliver batch-to-batch consistent dry powder cell culture media that are scalable from kilograms to tons.
EXECUTIVE INTERVIEW - Radius Health, Inc.: New Solutions for Healthy Aging
Drug Development Executive: Michael S. Wyzga, President & CEO of Radius Health, Inc., discusses what his company is bringing to the underserved market for women’s healthy aging solutions.
LIPOSOME PREPARATION TECHNOLOGY - Freeze Fracture Electron Microscopic (ff EM) Examination & Analysis of Liposomes Produced by Covaris AFA Technology
Srikanth Kakumanu, PhD, and Rajeev A. Jain, PhD, explain how an alternative ultrasonic processing technology allows manufacturing of liposomes of predetermined sizes and offers an efficient, isothermal, and non-contact process.
SPECIAL REPORT - Prefilled Syringes & Parenteral Contract Manufacturing: Improving for Flexibility & Customization
Special Feature: Contributor Cindy H. Dubin speaks with prefilled syringe manufacturers as well as contract parenteral manufacturers who share their thoughts about the delivery challenges associated with high-viscous, high-volume formulations.
ADVANCED DELIVERY DEVICES - Important Considerations in the Delivery of Large-Volume & Viscous Drugs
Kevin Cancelliere, MS, believes that as the trend toward self-administration continues, the need for careful consideration of primary container design, interaction with the drug product, method of administration, and end-user needs becomes even more critical.
AUTOLOGOUS CELL THERAPIES - Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success
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.
EXCIPIENT UPDATE - Delivering Gastric-Resistant Functionality Via a Colorless Top Coat
Philip J. Butler and Thorsten Cech investigate the gastric-resistant functionality obtained by applying a clear, two-component MAE coating formulation onto a tablet sub-coated with a pigmented instant-release coating and investigate the impact of hydrophilic and lipophilic plasticizers on the film characteristics of MAE-based coating formulations.
EXECUTIVE INTERVIEW - SNBL, Ltd.: Innovation in Drug Delivery Enabled Through a Unique Business Model
Drug Development Executive: Dr. Shunji Haruta, Founder of NDS (Nasal Delivery Systems) Division and Executive Officer, SNBL, Ltd., discusses how NDS Division and its powder nasal delivery platform, µco System, fit into a new paradigm.
FORMULATION DEVELOPMENT - A Call for Collaboration to Meet the Bioavailability Challenge
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., begins his multiple-part series discussing today’s most challenging issues in solubility.
FORMULATION DEVELOPMENT - Trends & Opportunities in Particle Design Technologies - Life Sciences & Biopharma in the Spotlight
Frost & Sullivan Analyst, Cecilia Van Cauwenberghe, MS, examines the observed trends in particle design and engineering technologies, as well as the main factors and opportunities driving the principal technological advances in the biopharmaceutical industry.
M*A*S*H
John A. Bermingham explains how it is incumbent upon CEOs and their management teams to triage all functional areas of the company when in times of trouble and the investors are looking for a quick fix to stop the bleeding.
MANAGEMENT INSIGHT - Rook to D7: Game Theory in the Pharma Industry
Derek G. Hennecke continues with part 4 of a new 6-part series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
MARKET FORECASTING - Monte Carlo-Based Forecasting: How to Deal With Uncertainty
Jemma Lampkin and Gerard Loosschilder, PhD, show how Monte Carlo-based forecasts are better at handling uncertainties, turning them into valuable tools for product managers and marketers engaged in strategic business planning.
TRANSDERMAL DELIVERY - New Frontiers in Transdermal Drug Delivery
Kenneth B. Kirby and Chandan A.S. Alam, MD, are part of a team at Transdermal Delivery Solutions Corp. (TDSC) that has been leveraging its patented technology to develop a unique patchless, metered pump, spray-on drug delivery system and products.
EXCIPIENT UPDATE - A Real Eye-Opener: Advances in Hyaluronic Acid for Ophthalmology
Hans Ole Klingenberg explains how Bacillus-derived HA offers new opportunities for ophthalmic applications by providing a safe and biocompatible source that can streamline manufacturing processes, while offering convenient application and increased patient comfort and compliance.
IMPURITIES DETECTION - Impurities Detection in Pharmaceuticals
Kevin P. Menard, PhD, focuses on the detection of residual solvents from processing and small levels of contaminates leached from containers.
INNOVATION AWARDS - Drug Delivery Award Winners Move Innovation Needle; Formulation Takes Center Stage
Marc Dresner presents the three companies that were honored by their industry peers with prestigious awards for breakthrough drug delivery innovation at the Institute for International Research’s 17th annual Drug Delivery Partnerships conference.
MANAGEMENT INSIGHT - Listening to the Voice of Inexperience
Derek G. Hennecke continues with part 3 of a new 6-part series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
SPECIAL REPORT - Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money
In this Special Report, Contributor Cindy H. Dubin asks many of the leading companies in this sector what challenges pharma currently faces in formulation and manufacturing and how they, as third-party providers, are helping to alleviate those burdens.
