Ensuring the Path to Compliant Analytical Methods

By |2020-11-10T15:23:54-05:0011/06/2020|

A gene therapy company spent over a decade developing their first-generation product, partnering for many early development capabilities. Then when the product was moving into the final stage clinical development, they bought out the rights and now owned 100% of the molecule. However, with a lean organization who had limited CMC and analytical [...]

Stage-Appropriate Quality Systems

By |2020-10-22T12:18:12-04:0010/22/2020|

Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon? We see some companies 'build for success' who [...]

Info Sheet: CMC Expertise

By |2020-11-06T15:00:05-05:0009/18/2020|

PDF Available > Development of advanced therapies requires innovative manufacturing and process engineering. CMC (Chemistry, Manufacturing, and Controls) activities expand, evolve, and refocus over time. Companies move from toxicology studies through IND-enabling activities, and from preclinical and clinical testing through commercialization. Tasks and objectives change, but the need for speed, precision, flexible thinking, and [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2020-10-02T10:05:28-04:0008/18/2020|

CMC QA/The Quality System Webinar on 9/30/2020 Request the Recording Request the Presentation Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place.  By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The [...]

Scaling Clinical while Preparing for Commercial Supply

By |2020-11-10T15:31:53-05:0009/17/2019|

Scaling Clinical while Preparing for Commercial Supply Introducing Demand & Operations Planning Service Areas: Supply Chain, CMC, Clinical Operations, Commercial Launch, Finance Lifecycle Stage: Clinical Assumptions and decisions built into clinical trial design have a major impact on emerging companies’ capacity planning and supply strategy. Protocol [...]

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