To apply the principles of Quality Assurance to all activities and systems with continuous evaluation and improvement, with a view to achieving consistent standards of quality.
To ensure that all personnel in the organization are committed to maintaining corporate quality requirements in every aspect of the business.
To comply with all statutory regulations of local authorities as well as those applicable to the overseas markets to which the products are being supplied.
QUALITY METRICS
Kemwell has created a culture of high quality and continuous improvement over the last 40 years.
No product recall or critical market complaint
100% Lot acceptance rate for DP manufacturing
>97% Lot acceptance rate for DS manufacturing
RFT for manufacturing operations >98%
Deviation rate per DP batch- < 1 deviation (No critical deviation)
Deviation rate per DS batch- < 3 deviations (No critical deviation)
VISION
To be a global leader and first-choice Biologics CDMO.
Become India’s first biologics CMO with USFDA approval.
Provide customized solutions to clients that accelerate their research and be their most trust-worthy go-to partner.
VALUES
Responsibility is first towards the patients.
Integrity in everything we do
Trust and Transparency – we have built this business over 40 years with a handful of customers, and we believe in being transparent and with that building trust with our partners.
Excellence – in everything we do from scientific research to efficient operations.
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Kemwell Services Overview
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Scale-up of Fed-batch Mammalian Cell Culture Processes
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cGMP Manufacturing
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Approach to Scale-up of Fed-batch Cell Culture Processes.
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High throughput screening for optimization of purification process
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Kemwell Analytical Development
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Stability Studies
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Process & Formulation Development
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Biologics Development
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Quality Control and Quality Assurance
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Analytical & Stability Testing Services Brochure
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Integrated Services
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