Raw Material Assessment

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Many biopharmaceuticals, especially cell-based products, use an array of non-standard raw materials in their manufacture. We’ll help you meet your responsibility for assessing and assuring their quality and safety.

 

Our experts can help conduct reviews of raw materials to identify any weaknesses in associated controls and propose solutions. We’re experienced in assessing both the safety of raw materials and their residuals, and can work with you to combine published information with your team’s own data.

 

Giving you confidence in quality from the ground up

 

In the absence of pharmaceutical-grade materials, you’ll be responsible for ensuring the quality of your raw materials and those used in their production.

The assurance of product safety and consistency relies on an assessment of the potential for toxicology and transmission of adventitious agents, combined with the efficiency of clearance from the manufacturing process and–where necessary–the ability to measure the residuals. Our experienced and knowledgeable experts can help with all of this.

 

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29.11.21
Biopharma Excellence

Roadmap to commercialization success: Build agility into drug development plans

By Dr. Diane Seimetz

We know the lifechanging impact that gene, cell and tissue-based therapies..

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If you’re developing something truly ground-breaking, Biopharma Excellence is the nearest resource you’ll find to someone who’s been there before.

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