Fueled by the country’s large population and rapid urbanization, China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future. According to our research, the country’s pharma segment is projected to reach $175 billion by 2022, with its biopharma sales on track to reach over $50 billion.
The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.
The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.
The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.
New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products. In Part 2 of this series, we cover the EU guideline and show how two diverge.
We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?
A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.
This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.
One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.
Combination products in the medical device industry now occupy a substantial market segment. This article focuses on the maximization of global regulatory collaboration in the marketing of combination products.
All formulators need a methodology that gives them reliable and useful information to identify problems before tablet manufacturing begins.
This white paper highlights the fact that there are no limits to progress in the pharma industry and provides an insight into the improvement potential of all processes in the supply chain using aggregation.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, so it is critical you find a partner that can help you overcome the inevitable challenges of drug development.
Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.
Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.
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