1. Are You Prepared For The EU’s Falsified Medicines Directive?

    Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.

  2. High-Density Fermentation For Renewable Chemicals Production

    A large variety of chemicals can be efficiently produced by microbial fermentation. They are used in a multitude of applications; for example, as biofuels, building blocks for polymers, food supplements, and ingredients for cosmetics.

  3. How Boehringer Ingelheim Significantly Ease Seamless Process Transfers

    The early involvement of Integrated Solutions bioprocess consultants, facilitated the implementation of a global single-use platform within Boehringer Ingelheim’s manufacturing network

  4. How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

    This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.

  5. The 5 Basic Tenets Of Data Integrity — And How Failures Occur

    It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards.  To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.

  6. Development Of An Efficient Manufacturing Process For Adenovirus

    Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. These challenges mostly arise from the size and complexity of the virus. Here, we present purification results of a process developed for the manufacturing of a recombinant adenovirus. This two-column process results in an adenovirus preparation comparable to clinical grade products, with high yield and very low host cell protein (HCP) and DNA contamination. It is readily scalable, simple, rapid, and efficient and thus well-suited for the production of clinical grade viral vectors.

  7. Brexit’s Impact On The Global Pharmaceutical Industry: Market Authorization & Pricing

    The Brexit referendum has resulted in instability and uncertainty for many aspects of British society, including the pharmaceutical industry. As we discussed in Part 1 of this two-part article, life sciences funding and the common market are at risk, and with it billions of dollars in research funding and imports/exports. In this article, we will explore the UK’s future relationship with the EU after exit, which will affect many facets of the worldwide pharmaceutical industry, from marketing authorization to global pricing trends.

  8. Accelerating Biopharmaceutical Development From DNA To Drug

    The pipeline of biopharmaceutical drugs is rich and becoming increasingly diverse. Many new biologic modalities are being developed as established therapeutic classes move through their lifecycle. Wide arrays of different types of molecules are expected to coexist within product portfolios and manufacturing networks. It is clear that this will have a significant impact on manufacturing facilities. Strategies need to be developed to prepare facilities for these challenges.

  9. Closed System Filling Technology: A New Paradigm

    “Closed system filling” is a new set of processing controls appropriate for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources through the use of closed systems. This is an automated sterile connector technology by which presterilized closed containers are filled through an engineered and controlled passage enabling the filled product, the internal container and the closure system surfaces to avoid exposure to the background environment.

  10. Brexit’s Impact On The Global Pharmaceutical Industry: Future Access To The EU Common Market

    On June 23, 2016, the voters of the United Kingdom voted to leave the European Union in an advisory referendum colloquially referred to as the “Brexit” (British exit) vote. The aftermath of the vote has been chaotic — from financial troubles that have seen the British economy and currency plummet, to political bedlam that has led to a number of political casualties, including the Prime Minister and his heir apparent. While analysts, journalists, and the public all discuss the impact of Brexit on the UK and the path forward, few realize the implications that the vote will have on healthcare, and the pharmaceutical industry in particular.