Bert Frohlich, Ph.D.

(Biopharm Designs LLC, aka BioFarm Designs) is a biochemical engineer and international consultant with more than 25 years of experience helping biotechnology and food companies translate scientific innovation into scalable, commercially successful manufacturing.

BIOPROCESS
QBD
PAT
CMC
REGULATORY
VALIDATION
CPV
DOE
MODELING
TEAS
Contact Details
EMAIL
bert@biopharmdesigns.com
PHONE
1 978 496 0182
Professional Profile
Bert Frohlich, Ph.D. is a biochemical engineer and international consultant with more than 25 years of experience helping biotechnology and food companies translate scientific innovation into scalable, commercially successful manufacturing. As founder of Biopharm Designs, LLC., he advises clients on commercialization strategy, bioprocess development, manufacturing scale-up, facility design, technology transfer, regulatory CMC strategy, and techno-economic analysis.
A Strong Background in Engineering & Design
Bert combines a strong theoretical background in cell culture, fermentation, and biochemical engineering with extensive hands-on experience designing, building, validating, and operating commercial manufacturing facilities. Throughout his career, he has successfully transferred numerous biologics and vaccines from development into manufacturing, contributed to FDA IND and BLA submissions, and led projects involving process validation, Quality by Design (QbD), Process Analytical Technology (PAT), and Continued Process Verification (CPV).
Before founding his consultancy in 2016, Bert held senior engineering and director-level leadership positions at Shire, Amgen, EMD, Sanofi (Acambis), Genzyme, Roche, and BioMetics, leading multidisciplinary teams responsible for process development, manufacturing support, facility design, and technology strategy. He later served as Vice President of Engineering and Commercialization at BlueNalu and Vice President of Engineering and Industrialization at Ivy Farm Technologies, where he directed engineering organizations, designed pilot and commercial manufacturing facilities, and developed commercialization strategies for cultivated meat products.
Today, Bert works with clients across the biotechnology and alternative protein industries, helping transform innovative science into scalable, commercially viable manufacturing processes. His expertise spans bioprocess engineering, manufacturing strategy, facility planning, regulatory support, organizational development, and economic modeling, enabling companies to reduce technical risk and accelerate successful commercialization.
Market Segments
Bioprocess Development
Process development for biopharma and chemicals
Media Development, DOE & Process Modeling
Media development and process modeling
Quality by Design (QbD)
QbD for process and analytical development
Chemistry, Manufacturing & Controls (CMC)
CMC regulatory documentation
Process Scale-Up & Tech Transfer
Process scale-up and technology transfer
Process Validation & CPV
Process validation and continued verification
Process Analytical Technology (PAT)
Real-time process monitoring and control
Management & Organizational Design
Organizational strategy and design
Biotech Facility Design & Cost Estimation
Biotech facility planning and costing.
Technoeconomic Assessments (TEA)
Technical and economic feasibility assessments.

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API Asia works with manufacturers, laboratories, and industrial operators seeking structured growth, execution, and reliable technical support across Asia-Pacific.

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