BioProcess Technology Group

• Provide day-to-day technical, quality, regulatory and project management support throughout all phases of product development 
• Offer technical and regulatory support to help you select the best expression system for your product and oversee cell line development and characterization 
• Support cell and gene therapy development and manufacturing options
• Develop or optimize upstream, downstream processes, incorporating current industry best practices
• Recommend, implement, qualify and validate analytical methods for in-process control, product testing, and characterization
• Prepare or review CMC development plans and strategies to de-risk your program and accelerate product development and assess any technical and regulatory gaps necessary to meet your critical CMC milestones 
• Identify, qualify, and manage contract manufacturers (CMOs) and other service providers for all modalities 
• Offer CMC program and project management 
• Develop and oversee process validation, characterization and comparability strategies 

• Establish Quality Systems and Quality Manual  
• Support and develop the Target Product Profile (TPP) and other key quality attributes 
• Develop CMC regulatory strategies and risk profiles 
• Write Module 3 and support FDA meetings relating to CMC 
• Negotiate BLA package, rolling submissions 
• Conduct cGXP compliance audits
• Review of IND and BLA applications and amendments 
• Offer PAI readiness, responses to FDA 483 “For Cause” audits and consent decrees

• Develop a short and long term supply chain strategy
• Assist CMO choice, clinical and commercial supply agreement negotiations
• Oversee CMO operations and compliance matters
• Improve delivery time to clinic and customer

• Make (in-house) vs buy (outsource) analysis
• Cost of Goods Sold (COGS)
• Technical due diligence
• Manufacturing network design

• Looking for a CMO or looking to build?  
• BPTG’s proprietary bioTRAK® database or bioTRAK® subscription can help you decide on the cost, time, and risks
• bioTRAK® uses public information on biopharma capacity 
• Provides detailed information and analysis on the balance of supply & demand of biomanufacturing capacity 
• Standard reports on macro/micro supply & demand 
• Custom reports on biomanufacturing capacity 

Our assessment professionals identify potential hurdles and risks. Using their industry knowledge, BPTG consultants provide the in-depth analyses you need to make sound strategic and financial investment decisions.

• Technology market assessments
• New product and supplier market assessments
• Technical and M&A due diligence
• Expert witness
• Process and economic modeling