Downstream Bioprocess Development Training Course

Name: Early Downstream Bioprocess Development Training Course
Availability: InStock

Design, screen, optimize, and prepare early biologics purification processes for scale-up and transfer.

At a glance

Duration: 1 Week
Format: Classroom
Cities: London, New York, Munich, Prague, Tbilisi, Porto and more
Next session: 9 – 13 November 2026, London
Average fee: 7,500 €

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Early Downstream Bioprocess Development Training Course

Overview

Early Downstream Bioprocess Development Training Course is a one-week intermediate course for downstream-development, purification, bioprocess, analytical, quality, and manufacturing-interface functions who leave with a Downstream Process Development Evidence Pack. Participants translate product and impurity attributes into a separation sequence, screen clarification, chromatography, membrane, and viral-clearance options, define scale-down studies, assess integration with upstream material, and prepare optimization and scale-up decisions. The course emphasizes evidence-led process selection rather than general biotechnology vocabulary. Agile Leaders Training Center presents early downstream bioprocess development.

Who Should Attend

Downstream-development functions responsible for purification routes and experimental plans
Bioprocess-engineering functions responsible for unit-operation integration and scale translation
Purification functions responsible for chromatography, filtration, recovery, and yield
Analytical-development functions responsible for product, impurity, and process evidence
Quality-development functions responsible for traceability, risk, and control rationale
Manufacturing-interface functions responsible for technology transfer and scale-up readiness

The course assumes participants already work with biologic materials, laboratory studies, or bioprocess data, and it leaves out introductory molecular biology, routine production operation, equipment certification, and product-specific validation protocols.

Departments and Industries

The course supports departments and industries that develop, transfer, or assure biologics purification processes.

Biopharmaceutical, vaccine, recombinant-protein, and biosimilar development
Process development, purification science, and bioprocess engineering
Analytical development, formulation interfaces, and quality development
Clinical and commercial manufacturing technology transfer
Contract development and manufacturing organizations
Life-science research, engineering services, and applied training laboratories

Learning Objectives

By the end of this course, participants will be able to:

Analyze product, impurity, and feedstream separation needs
Build an early downstream process-development strategy
Compare clarification, chromatography, and membrane options
Apply scale-down, screening, and optimization study designs
Evaluate viral-clearance, cleaning, and testing interfaces
Prioritize integration, scale-up, and transfer-readiness actions

Course Agenda

Day 1: Define the Separation Challenge

Target Product and Critical Impurity Profile
Upstream Feedstream Variability and Handover Register
Recovery, Purity, Yield, Throughput, and Quality Objectives
Downstream Unit-Operation Sequence and Decision Map
Development Risk, Assumption, and Evidence Register

Day 2: Develop Harvest and Capture

Cell Removal, Centrifugation, and Depth-Filtration Screen
Flocculation, Precipitation, and Crystallization Decision Factors
Primary Recovery Mass-Balance and Yield Calculation
Capture Chromatography Mode and Resin-Screening Plan
Feed Conditioning, Fouling, Capacity, and Cycle Assessment

Day 3: Build Purification and Viral Control

Ion-Exchange, Affinity, Hydrophobic, and Mixed-Mode Comparison
Polishing Step Selectivity and Impurity-Clearance Matrix
Ultrafiltration, Diafiltration, and Membrane-Selection Study
Viral Inactivation and Viral-Filtration Interface Map
Intermediate Hold, Pooling, Stability, and Compatibility Screen

Day 4: Optimize and Prepare Scale-Up

Scale-Down Model Purpose and Representativeness Criteria
Factor Screening, Experimental Range, and Response Matrix
Process Parameter, Performance, and Quality Relationship
Cleaning, Reuse, Testing, and Lifecycle Considerations
Scale-Up Basis, Equipment Fit, and Manufacturability Review

Day 5: Integrate the Development Package

Suggested Exercise: Define the Separation Strategy
Suggested Exercise: Compare Capture and Polishing Options
Suggested Exercise: Review Membrane and Viral-Control Interfaces
Suggested Exercise: Build a Scale-Down and Optimization Plan
Capstone Exercise: Complete the Downstream Process Development Evidence Pack

Practical Exercises

The course uses suggested activities to turn product, impurity, unit-operation, and scale evidence into a coherent development route.

Suggested activity: convert a feedstream description and quality target into a separation objective and unit-operation sequence.
Suggested activity: compare clarification, capture, polishing, membrane, and viral-control options against yield, purity, capacity, and risk.
Suggested activity: define scale-down acceptance criteria, experimental factors, responses, ranges, and evidence gaps.
Suggested activity: assemble process rationale, mass balance, study results, risks, controls, scale-up basis, and transfer actions.

FAQs

Who suits early downstream bioprocess development training, and what does it assume?

Early downstream bioprocess development training suits downstream scientists, purification specialists, bioprocess engineers, analytical and quality developers, and manufacturing-interface teams. It assumes familiarity with biologic materials, laboratory studies, or bioprocess data.

How does downstream process development differ from routine downstream manufacturing?

Process development selects and characterizes a purification route through experiments, models, and evidence. Routine manufacturing executes a defined process within approved instructions, controls, equipment, and operating ranges.

How are chromatography modes selected for a biologic?

Selection considers product and impurity properties, binding mechanism, selectivity, capacity, recovery, buffer conditions, fouling, cleaning, cycle time, scalability, and how capture and polishing steps work together.

Why are scale-down models used in downstream development?

Scale-down models reproduce the important behavior of a larger operation with less material and time. They support screening, optimization, characterization, troubleshooting, and risk assessment when their representativeness is defined and verified.

What belongs in a downstream process development evidence pack?

The pack contains product and impurity profiles, feedstream assumptions, separation rationale, unit-operation screens, mass balances, experimental plans and results, viral and cleaning interfaces, risks, scale-up basis, gaps, and transfer actions.

Conclusion

Participants take back a Downstream Process Development Evidence Pack containing the separation basis, feedstream profile, recovery sequence, screening studies, chromatography and membrane choices, viral-control interfaces, scale-down models, optimization evidence, scale-up rationale, risks, and transfer actions. The pack connects laboratory decisions to a traceable purification strategy. It supports clearer development reviews and more disciplined preparation for manufacturing.

credits: 5 credit per day

Course Mode: full-time

Provider: Agile Leaders Training Center

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Showing 1-20 of 58 events

Location	Dates	Duration	Mode	Price
London	Week 46, 2026 9 – 13 November 2026	1 Week	Onsite	€6,500
New York	Week 46, 2026 9 – 13 November 2026	1 Week	Onsite	€16,000
Munich	Week 47, 2026 16 – 20 November 2026	1 Week	Onsite	€6,500
Prague	Week 48, 2026 23 – 27 November 2026	1 Week	Onsite	€7,500
Tbilisi	Week 49, 2026 30 November – 4 December 2026	1 Week	Onsite	€5,700
Porto	Week 49, 2026 30 November – 4 December 2026	1 Week	Onsite	€6,500
Paris	Week 50, 2026 7 – 11 December 2026	1 Week	Onsite	€6,500
Accra	Week 51, 2026 20 – 24 December 2026	1 Week	Onsite	€6,000
Zanzibar	Week 51, 2026 20 – 24 December 2026	1 Week	Onsite	€6,000
Sharm El-Sheikh	Week 53, 2026 28 December 2026 – 1 January 2027	1 Week	Onsite	€5,200
Bali	Week 53, 2027 3 – 7 January 2027	1 Week	Onsite	€6,500
Kuala Lumpur	Week 01, 2027 4 – 8 January 2027	1 Week	Onsite	€6,500
Nairobi	Week 01, 2027 10 – 14 January 2027	1 Week	Onsite	€6,000
Toronto	Week 03, 2027 24 – 28 January 2027	1 Week	Onsite	€16,000
Bangkok	Week 04, 2027 31 January – 4 February 2027	1 Week	Onsite	€8,000
Addis Ababa	Week 05, 2027 1 – 5 February 2027	1 Week	Onsite	€6,000
Tashkent	Week 06, 2027 14 – 18 February 2027	1 Week	Onsite	€8,000
Zoom	Week 07, 2027 15 – 19 February 2027	1 Week	Online	€3,000
London	Week 08, 2027 22 – 26 February 2027	1 Week	Onsite	€6,500
Seoul	Week 08, 2027 22 – 26 February 2027	1 Week	Onsite	€12,000

Frequently asked questions

What does this course cover?

OverviewEarly Downstream Bioprocess Development Training Course is a one-week intermediate course for downstream-development, purification, bioprocess, analytical, quality, and manufacturing-interface functions who leave with a Downstream Process Development Evidence Pack. Participants translate product and impurity attributes into a separation sequence,…

Are training dates available?

Yes. Available dates and destinations are listed in the course dates section on this page.

How can I register?

Choose an available date on this page and complete the registration form, or send a programme enquiry.

Can I download the course brochure?

Yes. Use the brochure download link provided on this page.

Downstream Bioprocess Development Training Course