Modalities

• Monoclonal Antibodies

• Antibody-Drug Conjugates

• Recombinant Proteins

 

Process Development

• Oversight of cell line development activities

• Provide guidance for process development and scale-up strategies

• Review of process development reports

• CMC Lead for client projects

• Representing CMC area on Project Core Teams

 

CDMO Management

• Evaluation of RFPs received from CDMOs

• Management and oversight of CDMOs

• Site visits to CMOs for project kick-off and review meetings

• Person-in-plant during GMP manufacturing operations

 

Regulatory Support

• Biologics regulatory strategy development and implementation

• Writing and review of Module 3 IND Sections

• Support of FDA Requests for Information

 

Due Diligence Review

• Due Diligence Evaluations of CMC areas for venture capital funding