In January, the FDA banned imports from a fourth Ranbaxy plant in India after an unscheduled inspection revealed a lab littered with flies, a leaking…
RESIDUAL IMPURITIES – Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment
Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.
Thomas Otto believes a specialized CDMO can provide efficient solutions to the many challenges surrounding lyophilized substances. But it should be ascertained they have packaging, manufacturing, and lyophilization expertise.
Martin Magazzolo believes the cloud presents a strong alternative to costly internal solutions when managing content for R&D, allowing companies to shift their focus to innovation.
EXECUTIVE INTERVIEW – EMD Millipore: Enhancing the Bioavailability of Active Pharmaceutical Ingredients
Drug Development Executive: Steffen Denzinger, Head of Portfolio Development at EMD Millipore, talks about bioavailability challenges and how EMD Millipore’s formulation portfolio and expertise are helping the pharmaceutical industry achieve maximum efficacy with APIs.
MANAGEMENT INSIGHT – Six Reasons Why the Affordable Care Act May Be a Bad-Tasting Medicine That Could Heal Our Industry
Derek Hennecke says that whether you love the Affordable Care Act (ACA) or abhor it, the fact is, there are billions of dollars of government money in play and some industries are going to benefit tremendously.
EXECUTIVE INTERVIEW – Battelle: Innovation in Drug Delivery Through Integrated Science & Engineering
Drug Development Executive: Amy Heintz, PhD, Senior Research Scientist at Battelle, speaks about the company’s relationship with customers and the importance of integrating device design, formulation, and human factors in the development of safe and efficient drug delivery solutions.
Pierre Carlotti, Vice-President of Marketing and Communication for Aptar Pharma Prescription Division, talks about the market for auto-injectors and some relevant market trends, and explains how his company went about designing and developing a novel auto-injector.
BIOAVAILABILITY ENHANCEMENT – Navigating a Broad Spectrum of Solubilization Technologies: Part III of III
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., concludes his multiple-part series discussing today’s most challenging issues in solubility.
EXECUTIVE INTERVIEW – Catalent Applied Drug Delivery Institute: Helping to Get Better Drugs to Waiting Patients, Encouraging the Adoption of Advanced Delivery Technologies
Drug Development Executive: Kurt Nielsen, PhD, CTO & SVP, Innovation & Growth, and Founding Institute Board Member, discusses the Institute, its goals, structure, and activities.
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Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.
Ajinomoto Bio-Pharma Services recently provided an update on several of its capital projects currently underway in both the United States and Belgium.
SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, today announced the appointment of Dr. Haris Jamil as Biologics Manager of its recently expanded biopharmaceutical testing facility in Lincolnshire, Illinois, USA.
Pharmaceutical Product Development, LLC and Happy Life Tech of China have signed an exclusive agreement to develop a distinctive service offering for the China drug development market delivering data science-driven clinical trials and real-world evidence of drug products’ effectiveness, safety, and value.