One of the objectives of the upcoming ICH 12: Pharmaceutical Lifecycle Management guidance is to manage product development and manufacturing process information in order to establish and maintain appropriate change control over the entire product lifecycle. The 2014 ICH Q12 Concept Paper also stresses ICH Q12’s role in connecting ICH Q8 through ICH Q11 into a complete lifecycle approach to assure product quality and continuous improvement of manufacturing operations. However, neither the Concept Paper or subsequent public discussion and presentations appear to identify the ICH Q8 design space as a central mechanism for collecting and maintaining product and process information…
BioProcessing Journal Posts
You have worked tirelessly on your project and an opportunity arises to present your results. It might be a group meeting, departmental seminar, job interview, or scientific conference. Alternatively, you may need to raise money to fund your research, start a biotechnology company, or market a new product. In each of these instances, delivering your message effectively is essential to achieving your goal and earning the respect and admiration of colleagues…
The treatment of animal serum by gamma irradiation is performed to mitigate the risk of introducing undesired microorganisms (viruses, mollicutes, or other microbes) into a cell culture. Serum manufacturers and end-users utilize irradiation contractors to perform this process. The irradiation process must be validated, which involves establishing the: (A) minimum dose that achieves the required inactivation of the microorganisms of interest; (B) maximum acceptable dose at which the serum still maintains all of its required functional specifications; and (C) process used by the contract irradiator that allows treatment of the serum product within these defined limits. In the present article, we describe the best practices for qualifying the distribution and magnitude of absorbed dose (performance qualification [PQ] dose-mapping) when serum is gamma irradiated. PQ dose-mapping includes the following: (1) documentation of dose distribution characteristics in defined product load configurations for a specified pathway through the irradiator; (2) assessment of the process capability of the defined product load configurations and irradiation pathway for respecting the dose specification for the serum; and (3) development of a method for routine dose monitoring of the irradiation process with the defined product load configurations and the specified irradiation pathway…
I have to begin with a disclosure. I am a card-carrying, old-school, hypercritical academic who has always been among the first to complain about going to a conference and having to sit through an infomercial disguised as a science talk. But, perhaps I have a disguise of my own. I actually enjoy hearing talks focused on applied research and product development at least as much as more “academic” talks. I admire and respect the practical application of brilliant science. I believe that’s what scientists are supposed to do…
Filamentous fungi are an important class of organisms with significant commercial importance in the biotechnology sector. Those that dominate the markets and are deemed the most important include: Aspergillus, Penicillium, and Trichoderma. They have become indispensable for the production of enzymes due to their exceptionally high capacity to express and secrete proteins. In addition, recent advancements in genomics have allowed for the sequencing or partial sequencing of many of these species. The significance of these fungi and their associated enzymes has accelerated interest in understanding the mechanisms involved in the regulation of gene expression, primarily through the characterisation of the transcriptional elements involved…
Biological samples such as human tissue, cell lines, and serum specimens are a direct source of molecular data that can be used to identify targets for disease therapy, detection, and prevention. However, the validity and reliability of data derived from burgeoning analytical technology is highly dependent upon properly preserved, well-annotated biospecimens. As a result, biopreservation and biobanking have become an increasingly integral component in advancing today’s biotherapeutic development…
Fermentation utilizes organic substrates and organic electron acceptors to produce reduced organic substances as end-products. Bioethanol has a number of advantages over conventional fuels because it is produced from renewable resources. Ethanol is a high octane fuel that can replace lead as an octane enhancer in petrol by helping to oxygenate the fuel mixture so it burns more completely and reduces polluting emissions. The burning of ethanol more closely represents a natural carbon dioxide cycle since the released CO2 is recycled back into plants where the carbon dioxide becomes the carbon source for new sugars, starches and cellulose…
How much new business does it take to add $100,000 or even $1 million to the bottom line? Even with tax deadlines looming for companies that filed extensions, there is still time to maximize the benefits of all available tax credits and incentives. A powerful tax incentive known as the research and development (R&D) tax credit is available in the United States at both the federal and state levels to help manufacturers recover a significant amount of R&D costs…
In general, yeasts offer advantages for recombinant protein expression because their intracellular environment is suitable for the correct folding of recombinant proteins and grow very high cell densities in defined fermentation media. Within the yeast kingdom, Pichia pastoris has been successfully used for expressing several recombinant proteins. The genome of this yeast contains two copies of the alcohol oxidase (AOX) gene, where the AOX1 promoter regulates 85% of the alcohol oxidase activity and drives the recombinant protein expression into the cell. One of the most successfully recombinant proteins expressed in Pichia pastoris is the hepatitis B surface antigen (HBsAg). The current manufacturing process of the active pharmaceutical ingredient (HBsAg) of the Cuban hepatitis B vaccine (HeberBiovac™ HB) starts with the expression of the HBsAg in Pichia pastoris….