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BIOPROCESS TECHNOLOGY GROUP

Accelerating the biologics development process from clone to commercial

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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

CMC Product Development SupportQuality and RegulatoryManufacturing Strategy and
OperationsAsset and Pipeline Development
 * 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

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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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CASE STUDY

Case Study


PROCESS VALIDATION APPROACH FOR GENE EDITING CRITICAL MATERIALS

March 26, 2023

Learn how one company was able to develop and execute a risk and science-based
approach to validation for gene editing critical materials.

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LIFE SCIENCES INSIGHTS

Explore our most recent resources and thought leadership.

FEATURED

Article


A GUIDE TO DRUG MASTER FILES

October 16, 2022
Article


A GUIDE TO DRUG MASTER FILES

October 16, 2022

A master file is a confidential document that covers detailed information about
facilities, processes and articles used in the manufacturing, processing,
packaging, and storing of biologic, drug, and device products.

Read Morechevron_right

FEATURED

Article


PROCEDURAL REQUIREMENTS FOR INITIATING CLINICAL TRIALS IN THE EUROPEAN UNION

September 19, 2022
Article


PROCEDURAL REQUIREMENTS FOR INITIATING CLINICAL TRIALS IN THE EUROPEAN UNION

September 19, 2022

Prior to initiation of a first-in-human clinical trial, a sponsor must submit
scientific data to demonstrate that the drug product is safe for use in humans.

Read Morechevron_right

FEATURED

Article


THE STATE OF OUTSOURCED MAMMALIAN AND MICROBIAL CAPACITY

January 2, 2023
Article


THE STATE OF OUTSOURCED MAMMALIAN AND MICROBIAL CAPACITY

January 2, 2023

BDO’s bioTRAK database, which tracks supply and demand for biopharmaceutical
manufacturing capacity, is showing that outsourcing in the industry isn’t going
away anytime soon.

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Article


FIVE PRIVATE EQUITY TRENDS LIFE SCIENCES COMPANIES NEED TO KNOW

September 18, 2023
Article


FIVE PRIVATE EQUITY TRENDS LIFE SCIENCES COMPANIES NEED TO KNOW

September 18, 2023

Discover 5 private equity trends that your life sciences organization needs to
know about.

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Article


PLANNING A MANUFACTURING CHANGE TO YOUR CELL AND GENE THERAPY PROCESS? THE NEW
FDA DRAFT GUIDANCE HAS ANSWERS TO YOUR COMPARABILITY QUESTIONS

September 6, 2023
Article


PLANNING A MANUFACTURING CHANGE TO YOUR CELL AND GENE THERAPY PROCESS? THE NEW
FDA DRAFT GUIDANCE HAS ANSWERS TO YOUR COMPARABILITY QUESTIONS

September 6, 2023

The process defines the product. How then does a company approach making changes
to a CGT manufacturing process without altering the product? A new FDA draft
guidance, Manufacturing Changes and Comparability for Human Cellular and Gene
Therapy Products (July 2023), provides a road map.

Read Morechevron_right

Article


BDO BIOTECH BRIEF - SUMMER 2023

August 28, 2023
Article


BDO BIOTECH BRIEF - SUMMER 2023

August 28, 2023

As economic conditions shift, biotech companies are faced with a new normal as
biotech indices rebound from the lows seen in summer 2022.

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Article


MEDICAL TECHNOLOGY: ESTABLISHING PATIENT AND CONSUMER TRUST

July 5, 2023
Article


MEDICAL TECHNOLOGY: ESTABLISHING PATIENT AND CONSUMER TRUST

July 5, 2023

Medical devices have become increasingly complex, incorporating various sensors,
software, and connectivity features to improve health outcomes.

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Article


2023 BDO PRIVATE CAPITAL SURVEY

June 27, 2023
Article


2023 BDO PRIVATE CAPITAL SURVEY

June 27, 2023

Read our 2023 Private Capital Survey to learn how private equity fund managers
and CFOs are adapting to a slowing deal landscape.

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Article


CANADA RAMPS UP EFFORTS TO ELIMINATE FORCED AND CHILD LABOR IN SUPPLY CHAINS

May 25, 2023
Article


CANADA RAMPS UP EFFORTS TO ELIMINATE FORCED AND CHILD LABOR IN SUPPLY CHAINS

May 25, 2023

On May 3, 2023, the Canadian Parliament passed a bill (Bill S-211) focused on
environmental, social and government (ESG) policy, entitled “An Act to Enact the
Fighting Against Forced Labour and Child Labour in Supply Chains Act and to
Amend the Customs Tariff” (Act).

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Article


HOW HEALTHCARE AND BIOTECH CAN BENEFIT FROM NEW TAX CREDITS AND INCENTIVES

May 9, 2023
Article


HOW HEALTHCARE AND BIOTECH CAN BENEFIT FROM NEW TAX CREDITS AND INCENTIVES

May 9, 2023

Want to take your healthcare organization’s tax planning to the next level? Read
the insight insight to learn about available tax credits and incentives.

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Article


U.S. SENATE COMMITTEE EXPANDS ALLEGED FORCED LABOR PROBE INVOLVING MAJOR
AUTOMAKERS TO SUPPLIERS

April 12, 2023
Article


U.S. SENATE COMMITTEE EXPANDS ALLEGED FORCED LABOR PROBE INVOLVING MAJOR
AUTOMAKERS TO SUPPLIERS

April 12, 2023

The U.S. Senate Committee is expanding its probe into alleged forced labor
involving major automakers to their suppliers.

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Article


BDO BIOTECH BRIEF - Q1 2023

March 27, 2023
Article


BDO BIOTECH BRIEF - Q1 2023

March 27, 2023

2023 will be about finding balance as the biotech industry adjusts to its new
financial reality. Discover the latest updates in the industry in our Q1 Biotech
Brief.

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Case Study


PROCESS VALIDATION APPROACH FOR GENE EDITING CRITICAL MATERIALS

March 27, 2023
Case Study


PROCESS VALIDATION APPROACH FOR GENE EDITING CRITICAL MATERIALS

March 27, 2023

Learn how one company was able to develop and execute a risk and science-based
approach to validation for gene editing critical materials.

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Article


BLOCKCHAIN FOR YOUR LIFE SCIENCES & HEALTHCARE ORGANIZATION

March 3, 2023
Article


BLOCKCHAIN FOR YOUR LIFE SCIENCES & HEALTHCARE ORGANIZATION

March 3, 2023

Blockchain can be a game-changing technology for both life sciences and
healthcare, as it offers opportunities for efficient collaboration, transparent
data-sharing and enhanced security.

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Case Study


ENHANCE YOUR NETWORK STRATEGY WITH BDO

March 2, 2023
Case Study


ENHANCE YOUR NETWORK STRATEGY WITH BDO

March 2, 2023

Whether you want to reduce reliance on one location, optimize and move your
current locations, address shrinking operating margins, improve agility or
support growth, BDO can help you achieve those goals.

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Article


ANTIBIOTIC RESISTANCE – OPPORTUNITIES FOR LIFE SCIENCES COMPANIES TO PROVIDE
SOLUTIONS TO THIS PUBLIC HEALTH CONCERN

January 30, 2023
Article


ANTIBIOTIC RESISTANCE – OPPORTUNITIES FOR LIFE SCIENCES COMPANIES TO PROVIDE
SOLUTIONS TO THIS PUBLIC HEALTH CONCERN

January 30, 2023

Antimicrobial resistance (AMR) is a top threat to the public’s health and
remains a worldwide priority.

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