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Growing Billions of Human Cells in the Lab, ... Faster!

There are four fundamental types of tissues in the human body: epithelium tissue, which is responsible for absorbing or secreting materials and for protecting tissue surfaces; muscular tissue, which is responsible for the movements of body organs such as the digestive tract and for skeletal movement; connective tissue, the most widely distributed tissue in the body supports and connects other tissues together; and finally, nervous tissue, which is capable of receiving stimuli and transferring signal and then bringing about a response.

Biopharma's Worst Nightmare: An FDA Recall.

Part I: The Good

The year 2017 was full of positive news for the Biopharma industry. Several biologic therapeutic “firsts” have recently been approved by the FDA: Kymriah, the first gene therapy in the US, which is approved for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse; MACI, the first FDA-approved product for repairing knee cartilage defects in adults that is grown from cells on scaffolds using healthy cartilage tissue from the patient’s own knee; Odactra, the first allergenic extract to be administered under the tongue for the treatment of house dust mite-induced nasal inflammation; and Haegarda, the first subcutaneous preventive treatment option for hereditary angioedema (HAE), which enables easier at-home self-injection by the patient or caregiver, to prevent HAE attacks in adolescent and adult patients. Dozens of other promising biologic therapeutics and treatments are in the pipeline. The race to profitable biologics is on!

Biopharma's Worst Nightmare: An FDA Recall.

Part II: The Bad

CONTAMINATION

Biologics have revolutionized the treatment of such chronic illnesses as rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease, and multiple sclerosis, and are widely used in treating a variety of cancers. To name just a few, these products include Enbrel, Humira, Remicade (infliximab), Avonex (inteferon beta-1a), Betaseron (interferon beta-1b), Tysabri, Cimzia (certolizumab pegol), Herceptin (trastuzumab), Rituxan (rituximab), Neupogen (filgrastim), Erythropoietin (EPO), Neulasta (pegfilgrastim) and Leukine (sargramostim). 

 A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process.

Biopharma's Worst Nightmare: An FDA Recall.

Part III: The Ugly

Detection is one way to avoid having a contaminated batch from being released. However, detection cannot eliminate bacteria as a potential contaminant. Burkholderia cepacia, a common cause of FDA recalls, could be eliminated, in principle, using micro-filtration, 0.2 - 0.4 micron filters. In practice, the pore size in micro filters are just an average value, not a guaranteed maximum pore size. Pore size distributions are statistical measures around a mean value. Smaller and larger pores are possible. The specified average pore size only assures the value of the average pore size, not the size of the largest available pore or the absence of pinhole imperfections in the manufactured of the industry standard cellulosic (paper) and nylon (polymeric) filters.  Note also that micro-filtration cannot eliminate mycoplasma, even if the stated pore size, say 0.2 microns, could be made within a very narrow distribution, say within a maximum deviation of 10% (0.18-0.22 microns). Scanning electron micrographs of most commonly used filters in bio-pharmaceutical production and R&D ...

Biopharma's Worst Nightmare: An FDA Recall.

Part IV: Gunfight at the OK Corral

Consider that a typical animal cell measures roughly 10 µm across. Bacterial cells are typically about 1 micron, 1000 nm, and viruses can be 10 times smaller than bacteria. Somewhere around 50 nm we can separate life threatening components from life sustaining ones. To illustrate this concept, we depict the typical size limits between life giving (biologics, nutrients, water) and life-threatening agents (viruses, bacteria, cancer cells). A clear demarcation, around 50-60 nanometers, exist between these two regimes, as illustrated in Fig. 4. We can think of this limit as a bio-safety GATEWAY that must be closely guarded to eliminate potential sources of contamination for both R&D practices as well as in biologics and pharmaceutical production streams….

The Age of Photonics: Beyond Electronics

Current electronics are prevalent in almost every aspect of day-to-day life. However, from fiber optics and telecommunications to medical imaging and cancer research, optics and photonics are advancing today’s critical technologies.