Links to Other SOPs and Regulatory Documents

Association of Academic Biologics Manufacturers (AABM) is a cooperative network of non-profit academic based biologics manufacturers serving as a national resource to bring together clinical investigators with manufacturing capacity and expertise, develop and share facility operations expertise amongst members, provide quality, manufacturing and regulatory training opportunities, and hold annual meetings. AABM has assembled a library of SOPs that are available to registered members. The available SOPs cover such areas as facility operations, biological waste management, good documentation practices, document control, employee training policies, and gowning. Register to become a member or register your facility and receive access to these SOPs at www.aabmonline.org. There is no fee to register.

 

The Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) provides resources and expertise for development of investigational biological agents. The BDP supports feasibility through development and Phase I/II cGMP manufacturing plus regulatory documentation. The BDP has over 300 documents online that are available free for any investigator, company, or group developing biopharmaceuticals. These documents are useful to scientific, clinical manufacturing, quality control and quality assurance professionals.

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