Development Runs at Lonza Sample Clauses

Development Runs at Lonza. The ESS project at Lonza has included research and development for process improvements. Currently Lonza has performed 6 development experiments, 9 full engineering runs, and 22 partial engineering runs. Developmental research at Lonza has been focused on the reduction of animal origin materials, media optimization, improved cell yield from isolation, reduction of growth factors, and comparable or improved growth of keratinocytes and fibroblasts before and after inoculation of ESS. Engineering runs and experiments varied in size and remained small for training purposes. Expected yields can be based on the following results: Development Run Example A Biopsy size= 30 cm2 Number of days in culture: P1= 6 P2= 5 P3= 5 on ESS= 13 Total Number of days before release= 30 Total ESS made from 2E6 fibroblasts and 4E6 keratinocytes= 8 Potential total amount of ESS produced per lot= 2385 cm2 Total skin expansion = ESS area / biopsy area = 2385 / 30 = 80 fold Development Run Example B Biopsy size= 42 cm2 Number of days in culture: P1= 7 P2= 6 P3= 6 on ESS= 14 Total Number of days before release= 33 Total ESS made from 2E6 fibroblasts and 4E6 keratinocytes= 4 Potential total amount of ESS produced per lot= 4706 cm2 Total skin expansion = ESS area / biopsy area = 4706 / 30 = 157 fold Estimated Model for Clinical production lots Biopsy size= 30 cm2 Number of days in culture: P1= 6 P2= 6 P3= 6 on ESS= 13 Total Number of days before release= 31 Total ESS made from 2E6 fibroblasts and 4E6 keratinocytes= 20 Potential total amount of ESS produced per lot= 3600 cm2 Total skin expansion = ESS area / biopsy area = 3600 / 30 = 120 fold
Sample 1
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Related to Development Runs at Lonza

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  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

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