Gathering information about batch failure rates in the biopharmaceutical industry is about as easy as getting politicians to talk about their most embarrassing gaffes and indiscretions. Although it comes as no surprise that batches do fail, some readers may be surprised at how relatively well many organizations appear to be performing. Based on the results of our recently released annual report and survey (1), facilities are experiencing batch failures at an average rate of about one every nine months (40.6…
Business
Reviewing the Real Costs of GMP Compliance
Readers of our February 2008 article “Construction and Start-Up Costs for Biomanufacturing Plants: Canadian Case Studies in the Cost of Regulatory Compliance” may have noticed something missing (1). Two somethings, in fact: First, biographical information for coauthor Agnès Coquet was not listed at the end of the article. She is manager of analytical development for Debiovision Inc. of Montreal, Quebec, in Canada; 1-514-842-9976, ext. 104; acoquet@debiopharm. ca. Second, “Table 1” was called out on the fourth page of the article…
From Pandemics to Bioterrorism
On 28 March 2008, BioProcess International hosted a panel discussion at the annual INTERPHEX conference (26–28 March 2008 in Philadelphia, PA), titled “From Pandemics to Bioterrorism: The Role of Bio-Manufacturing in Global Healthcare.” The discussion format grew out of a series of conversations over several months involving the panel members, INTERPHEX organizers, and BPI’s editor in chief (all participants are listed on the previous page). The group started with the premise that the biotechnology industry has a vital role to…
Effect-Based Compliance
Regulatory compliance is a competitive team activity that creates real value reflected in the bottom-line accounting of company profitability. Champions earn freedom to operate for their companies; losers are enjoined, have products seized, and/or are prosecuted for their (mis)deeds. The players and fans use FDA form 483s and warning letters as metrics for measuring relative standing. The operational paradigm is that “employees” tend to define competitors in the context of a company’s market. In the regulatory game, competitors are less…
Opening the Door to the Chinese Pharmaceutical Market
Virtually all aspects of the Chinese economy are booming, not the least of which is its pharmaceutical sector. Growing at 20% over the past five years, the $15 billion Chinese pharmaceutical market is predicted to become the world’s fifth largest by 2010 (1), making China an attractive place to do business for multinational pharmaceutical companies (MPCs). Rising living standards and improvements in China’s regulatory and technology infrastructure are the key drivers for this continued growth. Although all segments of the…
Process Excellence
Life-science companies that adopt “quality by design” (QbD) into their overall operations are expected to achieve the “desired state” of manufacturing. So concludes the Q10 document from the EMEA, US FDA, and the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (1). The ability to achieve an appropriate quality outcome must be designed into each manufacturing process rather than companies relying on final product testing. An increased focus on QbD ultimately requires manufacturers…
In the Industrial Zone
Figure 1. The same genomic and proteomic technologies used to discover new drugs and therapeutics are also changing the way we live and some of the products we buy. Technologies have yielded new enzyme biocatalysts, used in producing raw and intermediate materials and consumer products. In addition to improving crop and food production, companies are using the tools of biotechnology to manufacture materials from renewable and sustainable resources, build environmentally sound industrial processes, and develop innovative solutions to growing global…
In the Drug Delivery Zone
A rule of thumb in drug development states that the larger a therapeutic molecule is, the more trouble it will be to make, ship/store, and administer to patients. Biotherapeutics include proteins (such as antibodies), vaccines, some smaller peptides (such as hormones), DNA for gene-transfer therapies, cells and tissues, and to a lesser extent blood-fractionation products, allergenics, and RNA/oligonucleotides. Biomolecules are big and unwieldy, they’re produced in complex mixtures by biological processes, and they face numerous challenges in storage and within…
In the Clinical Trials Zone
A new product takes a long and winding road from a laboratory to the patients it is designed to help. Many factors and organizations affect just how many months and dollars it will take to shepherd a new product from preclinical studies to market. Carefully documented, regulatory-compliant clinical trials are key to marketing approval. Clinical trials involve a choreographed network of regulatory agencies, sponsor companies, and clinical investigators. Myriad specialists in that network include those who produce and deliver an…
In the Bioprocess Zone
Since the turn of the century, industry analysts have touted the “coming of age” of the biotech industry — and they’re inevitably talking about biopharmaceuticals. In fact, biotech has become the innovation engine for the pharmaceutical industry as a whole. Advances in genomics, proteomics, and other biotech research are bringing about not only new drug molecules, but also whole new therapeutic classes such as gene and cell therapies. Biotherapeutics represent the fastest-growing segment of the pharmaceutical industry, with more than…