When analyzing the complete market for human diagnostic products, with an estimated value of $30 billion annually, the $2 billion market for molecular diagnostic methods is still relatively small. However, with a growth rate of 20% per year, this segment is growing faster than any other in in vitro diagnostics. The reason for this is that healthcare systems have just begun tapping the tremendous potential to which this new technology gives us access. Whereas in the past, large reference laboratories and academic teaching hospitals were the driving force, today the customer base is increasingly made up of smaller diagnostic labs and clinics. Other features of the market are the wide-reaching protection of intellectual property and high product values, due to the significantly higher development and production costs…
BioProcessing Journal Posts
Regulatory agencies such as the FDA require the structure and amino acid sequence characterization of recombinant monoclonal antibodies (MAbs) to grant marketing approval. Characterizing such complex, inherently heterogeneous molecules is a significant analytical challenge that requires a broad array of physicochemical tests. Mass spectrometry (MS) is an essential tool for characterizing protein identity, functions, substrate specificity and amino acid sequence (AAS) of recombinant MAb biotherapeutics as it complements, or in some cases supersedes the utility of traditional biological methods. For some of the most important proteomic applications, the high sensitivity and accuracy provided by modern MS has allowed the unequivocal protein characterization…
The aim of personalized medicine is to provide the customized treatment likely to work best for each individual. A narrow interpretation of the definition attributes the appropriate treatment to be based on the patient’s molecular phenotype. A broader interpretation includes cell-based therapies that are derived from a patient’s own cells, or cells from a related or tissue-matched donor. Basic research findings contributing to the knowledge of the molecular and cellular basis of immune-mediated control of cancer and infectious diseases have created opportunities to develop new forms of cell-based vaccination for cancer and chronic infections like HIV. Cell therapy laboratories have developed from their roots in bone marrow transplantation and blood banking into what can now be described as cellular engineering laboratories where cells can be isolated, enriched, transduced, activated, expanded and otherwise manipulated in ways to change or enhance the function of in vivo-derived cells for eventual reinfusion…
The recent discovery of cancer stem cells in leukemia, brain cancer, and breast cancer has had a significant impact on cancer research and how cancers are thought to arise. Their discovery has resulted in unique, but pressing challenges that may ultimately only be resolved through the development of large-scale bioprocesses. The scarcity of these cells is currently impeding discovery of new cancer treatments that specifically aim to eradicate the population of tumour cells thought to be responsible for tumour growth and metastasis. Fundamental bioprocessing principles have been applied to develop scalable, large-scale cultures for cancer stem cells, to address this issue of cancer stem cell scarcity. Development of such bioprocesses differs significantly from other, more conventional cultures since it is the cells themselves that are of interest rather than the products of the cells (e.g., proteins)…
Manufacturers of biological products have come to accept that it makes sense, from both a business as well as a regulatory perspective, to address GMP compliance issues with bioprocessing methods as early as possible in product development. Logically, this same reasoning would also apply to the associated analytical methods used to characterize the product; however, companies still frequently leave methods optimization and validation until later in the developmental timeline which can expose them to unexpected regulatory challenges. In addition, as therapeutics increase in complexity (e.g., cell therapies, transgenics), it raises the likelihood that product characterization will be assessed by novel and increasingly intricate assays—making it difficult to follow a “one size fits all” approach to method selection, development and validation…
One of the major concerns facing relatively young biotechnology companies once a lead product has been identified is the issue of manufacturing. Usually this involves the upscaling of a lab-scale process while at the same time, complying with good manufacturing practice (GMP) to ensure a reproducibly-produced and consistent product. It also involves the establishment of specific and robust assays in process controls and release criteria. This issue has become more acute in the EU since 2004 due to the EU Clinical Trials Directive requiring GMP-certified production of investigational medical products even for phase I trials. Startup biotech companies are often limited in their finances and resources, as well as being bound by tight milestones. Quite often the expertise in upscaling and GMP-compliant production as well as the facilities and equipment required are not available in-house…
In recent years, cell therapy has been suggested as a promising approach for repair and regeneration of damaged tissues. VesCell™, a blood-derived autologous cell therapy product consisting of ex vivo enriched angiogenic cell precursors (ACPs) was developed by TheraVitae for the treatment of severe heart diseases. A non-mobilized, blood-derived cell population consisting of low density cells, termed synergetic cell population (SCP), was isolated and cultured in the presence of serum-free medium (X-Vivo 15, Lonza, Walkersville, MD, USA) supplemented with growth factors and autologous serum to yield VesCell. Significant cell numbers (>50×106) exhibiting morphological, immunocytochemical, and functional characteristics of the angiogenic cell lineage were obtained from blood samples. The ACPs expressed the hematopoietic stem cell (HSC) markers CD34, CD133 and CD117, as well as specific angiogenic markers such as vascular endothelial growth factor receptor 2 (VEGFR2) (receptor 2 [R2] is also known as kinase domain region [KDR]), CD144, and CD31…
The efficacy of pharmaceuticals, nutraceuticals, and cosmeceuticals depends not only on the chemical composition of the active ingredients, but also on the formulation of the product and the method of delivery. Nanoemulsions—formulations that encapsulate drug or nutrient molecules in sub-micron-sized oil droplets suspended in water—have been found to increase the rate and level of absorption into the body, and offer other benefits including the mitigation of side-effects as well as an antiviral and antibacterial action. With an emulsifier layer surrounding the droplet, nanoemulsions exhibit high levels of stability for extended periods of six months or more…
Controlled cell deposition by way of micrometer-sized jets are increasingly becoming a fiercely pursued area of research. We recently uncovered the ability to jet living cells using one such jetting methodology, now referred to as bio-electrosprays. This technique has never been explored for processing living cells until now. Electrosprays charge media within a needle, subsequently imposing an external electric field to assist in drawing the media into a micro-jet. The resulting instabilities assist in jet break-up, forming cell-bearing droplets. These droplets containing viable cells could be deposited onto a wide variety of biological and non-biological substrates. In this article, we report our developmental studies into this jet approach with a view to the successful handling and deposition of primary neonatal cardiac myocytes…
Key questions for any company planning to build a new facility include processes to be followed for effective design, commissioning, and qualification. Pilot plants need to be flexible, but as flexibility increases, so does complexity and cost. The scope of the new clinical trial pilot plant for bioprocess operations at Eli Lilly and Company (K360) was based on specific technology platforms and extensive benchmarking. Global regulatory issues had to be considered in the design as well because the material it produces will be used worldwide. The K360 plant has the capability to produce mammalian, bacterial, and yeast-based protein and peptide products following typical processes for growth in bioreactors. The protein or peptide of interest is recovered following fermentation and then purified in the facility. The plant’s output is bulk active pharmaceutical ingredient (API)…