BioProcess Technology Group

Accelerating the biologics development process from clone to commercial

Accelerating biopharmaceutical process development

BDO’s BioProcess Technology Group (BPTG) is a world leader in providing strategic, technical, regulatory and business consulting services to the biopharmaceutical industry. 

We understand firsthand the challenges of developing and commercializing new products and technologies. BPTG provides full-service, flexible and responsive biotech consulting services to help clients through complex technical and regulatory issues, allowing them to achieve key business milestones. 

The breadth of our experience is extensive, ranging across business strategy, due diligence, chemistry, manufacturing and controls (CMC) advisory, supply chain planning, make vs buy, Cost of Goods Manufactured (COGM) modeling, expert witness testimony and more. We can help you manage all elements of drug development either across the product life cycle or for targeted, short-term consultations on specific technical, quality, regulatory or operational issues. Our technology consultants have an average of 30 years of industry experience from big pharma to startups. We continually demonstrate our thought leadership across various disciplines and provide actionable insight, targeted analyses and practical strategies to help address the technical, quality and regulatory challenges of product development and commercialization. 

By applying our deep technical understanding and broad experience in biopharmaceuticals and bioprocess technologies, BPTG can play a key role in facilitating — and accelerating — your success. 

How BDO Can Help

  • 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 

BDO will advise and assist with the quality, regulatory, and compliance requirements for your product and organization at all stages of product development and commercialization. 
  • 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

Our CMC experts help you deliver quality drug material and the data required to support global regulatory filings throughout all stages of your product’s lifecycle:
  • 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
Our process economic modeling tools help to understand "total cost ownership":
  • Make (in-house) vs buy (outsource) analysis
  • Cost of Goods Sold (COGS)
  • Technical due diligence
  • Manufacturing network design
Our bioTRAK® Report - Bio-Manufacturing Capacity Database and Analyses:
  • 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

Who We Serve

Our team of bioprocess 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: 

Multinational Biopharmaceutical Companies

Early-Stage Biotechnology Companies 

Cell and Gene Therapy Companies

CDMOs, CMOs, Laboratories and Suppliers

Investment Firms and Service Providers


The BPTG Résumé Book

Ready to take the next step in improving your drug development process?  

Complete the short form to access our BPTG Résumé Book, which details our team’s professional experience, publications, presentations, patents and more.

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Together, we thrive.

Everything we do is rooted in our core purpose to help people thrive every day. It’s not only the right business thing to do; it’s the right human thing to do. This starts by putting our people at the center of our work and extends to how we treat and value our people, our clients and our communities. With a dedication to quality and a purpose-driven culture, BDO offers a powerful choice both for clients and those seeking rewarding professional careers.