our services include
CMC Product Development Support
Quality
and Regulatory
Manufacturing Strategy and Operations
Asset and Pipeline Development
CMC Product Development Support
u
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, quality (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
u
u
u
u
u
u
u
u
Quality and Regulatory
u
u
u
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
u
u
u
u
u
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.
Manufacturing Strategy and Operations
u
u
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 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:
u
u
Our process economic modeling tools help to understand "total cost ownership":
u
u
u
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:
u
u
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
u
Asset and Pipeline Development
u
u
u
u
Technology market assessments
New product and supplier
market assessments
Technical and M&A due diligence
Expert witness
Process and economic modeling
u
u
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.
u
u
u