Avecia Deliverables. 6.1.3.1 [* *] report, including Avecia analysis of previous work:
Avecia Deliverables. 6.2.3.1 [* *] report, including Avecia analysis of previous work: • Master and executed batch records • [* *] • [* *]
6.2.3.2 [* *] API [* *]
6.2.3.3 Analysis of [* *] API
6.2.3.4 Plan for [* *] during [* *] stage
Avecia Deliverables. 6.3.3.1 [* *] transfer report, including Avecia review of previous work:
6.3.3.2 Plan for [* *] work during [* *] stage (in conjunction with Stressgen [* *])
6.3.3.3 Formulated [* *] API batches
Avecia Deliverables. 6.4.3.1 [* *] transfer report; including analysis of:
6.4.3.2 Plan for analytical work [* *]
Avecia Deliverables. Meeting minutes, action items, and completed transfer summary report [*] = CONFIDENTIAL TREATMENT REQUEST(ED).
Avecia Deliverables. Experiments to: • Characterize [* *] • Determine [* *] — Cell Paste storage data • Evaluate [* *] vs. [* *] phase • Characterize [* *] scales and steps • Determine [* *] strategy
Avecia Deliverables. Experiments to investigate: • Initial [* *] • [* *] • [* *] • [* *] HspE7 • [* *] • Final overall HspE7 [* *] • [* *] [*] = CONFIDENTIAL TREATMENT REQUEST(ED).
Avecia Deliverables. Experiments to: • [* *] • [* *] • [* *] of HspE7 • [* *] of the formulated API
Avecia Deliverables. Experiments to: • [* *] methods [* *] • [* *] assays as required, e.g., • [* *] need • [* *] • Review [* *] for entire process • [* *] batch release and stability assays
Avecia Deliverables. 7.6.3.1 Summary [* *] Report, including [* *] plans and goals for [* *] stage. Upon Stressgen’s approval to proceed with [* *], Avecia will execute the [* *] from the [* *] stage in order to develop [* *]. Avecia will parallel track its work to the extent possible, and will resource the work adequately to allow [* *], particularly on [* *]. This stage will [* *] the final [* *] for the pivotal clinical trial supply and commercial manufacture, and produce pilot batches at scale.
