• BioProcess Technology

Accelerating the biotherapeutic development process.  From clone to commercial. ®

At BDO, we help innovative companies become even more innovative, cost effective and viable. Our team of bio-process industry veterans with an average of 30+ years of experience offers a wide variety of support and services, helping our clients in all stages of the product development and commercialization  lifecycle.
 
BDO’s BioProcess Technology Group (BPTG) provides an integrated approach to de-risking the technical and regulatory challenges in the development and commercialization of biopharmaceutical products that improve patients’ lives.  We strive to exceed our clients’ expectations and to be recognized for our technical excellence, thought leadership, integrity and outstanding service.  Our services include:
 
Your manufacturing programs must deliver quality materials while providing the data required to support regulatory filings for clinical and market applications globally. Our CMC experts will help you strategize throughout all stages of your product’s lifecycle.
 
Whether you’re a late-stage development company approaching market approval, or a multi-national pharmaceutical company, BPTG’s advanceONE® services can help you address the quality, regulatory, and compliance needs of your product and organization at all stages of product development and commercialization.
 
Our extensive experience across product modalities (including nucleic acids, peptides, proteins, monoclonal antibodies, antibody drug conjugates, gene therapies, and cell therapies) helps to accelerate product development and minimizes technical and regulatory risks.
 
BPTG’s process economic modeling experience allows you to evaluate manufacturing costs, compare manufacturing options, and identify bottlenecks in your manufacturing processes.
 
BPTG provides objective analyses to inform critical business and investment decisions. Our assessment professionals identify potential hurdles and risks and use their industry knowledge to provide the in-depth analyses you need to make sound strategic and financial investment decisions.
 
Whether you are assessing the market potential for your product or determining if there is enough manufacturing capacity to meet a certain type of biopharmaceutical product demand considering an investment, BPTG’s proprietary bioTRAK® database can help.
 
  • Risk assessment and risk management
  • cGXP compliance assessments
  • IND and BLA filing and amendments
  • PAI readiness assessments and gap analysis
  • cGXP audits
  • Support with resolution of FDA 483s
  • Support with “For Cause” audits and FDA consent decrees
  • Project Management and execution of corrective action plans