COVID-19 The BALS employs live porcine hepatocytes (pig
liver cells) as its active agent and, since transfer of live biologic products across national borders is universally difficult, this will require separate validation of the company’s operations, and each of those countries to establish compliance with both international and local standards.
“From being unknown in the beginning of 2020, coronavirus – now known as SARS-CoV-2 – currently impinges upon virtually every aspect of life and topics of discussion. From eating out at a restaurant to conducting clinical trials.”
Operational biosecurity was elaborate prior
to the appearance of SARS-CoV-2 and, while in one sense EBIL has merely yet another pathogen to consider, the protections against SARS-CoV-2 impose no new qualitative restrictions. Personal hygiene, animal and facility cleanliness, and attention to detail will be more closely monitored, but will not introduce significantly new procedures. In biosecurity, as in cybersecurity, security breaches are most commonly the result of human error. We will address this continuing human frailty by rigorous, frequent training of our people, consistent monitoring and continual improvement of our processes.
A modular approach Our key starting material – pigs – are vulnerable to a wide variety of diseases, with many animate and passive vectors. Animal husbandry facilities are designed so that our specially raised, fed and bred pigs are isolated as much as possible from humans, other rodents, birds and, often, from other pigs. For example, African Swine Fever Virus (ASFV), although not yet present in the US, is currently largely uncontrolled in large parts of Asia. To this point, we have compiled a list of over 30 pathogens for which we must routinely and periodically test, and retest our pigs. It is unclear how susceptible pigs are to SARS-CoV-2, but we plan to treat it as a disease that is at least
102 | Outsourcing in Clinical Trials Handbook
as potentially hazardous to pigs and human health as ASFV is. We are designing our animal husbandry facilities with a modular approach, to simplify and standardise construction. These will include systems to control air, water, feed and waste disposal. People and vehicles will be thoroughly sanitised in a tiered approach prior to being allowed contact with our pigs. We design all systems, to the extent possible, so that the only way to perform a procedure is the right way. At EBIL, the QMS is the only management system controlling all operations, animal husbandry, bioreactor production, research and development, employee data and training, sales and marketing, clinical trials, patient data, finance and administration. When a cohort of pigs is ready for liver
harvesting, they are transported from the animal husbandry facility by careful handling in sanitised trucks, by sanitised employees, to the manufacturing facility for bioreactor manufacturing. As with the animal husbandry operations, no new, qualitatively different protections need to be imposed, but enhanced rigor on personal,
surgical room and bioreactor preparation hygiene and waste disposal will be enforced.
Also, for an unknown period of time, as it is unlikely that social distancing will
be workable in a manufacturing environment to prevent person-to-person infection, it is likely that personal protective equipment, such as N95 masks and protective gloves, will be required of all personnel at all times. This is not only to protect the pigs and pig tissues from contamination, but to protect workers against possible infection from each other as well.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120
