Cutting edge process development insights and news from APC.
In the development of Biologics, a lack of proper process understanding and control often leads to an inability to adequately scale a process, product quality drift and costly delays arising from batch failures and concerns of the regulatory authorities which need to be addressed. APC has developed a unique approach designed to mitigate these issues.
Tech transfer of Advanced Therapy Medicinal Products (ATMPs) presents additional challenges above and beyond those faced when transferring more traditional biologic or small molecule products. Learn more about four essential overarching elements which should be included in the development plan for any ATMP.
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