Biopharmaceutical Process Development and Scale-Up Corporate Training
Learn to develop, scale up, and transfer biopharmaceutical processes, in live guided labs.
Edstellar, a corporate training company, delivers corporate training that helps your team learn to design, characterize, and scale up biopharmaceutical manufacturing processes. Employees develop upstream and downstream expertise, apply Quality by Design, and build tech transfer discipline through guided labs led by practitioners. Each session is tuned to your molecules, platforms, and workflows.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a robust bioprocess development team
The Edstellar BIOPROCESS DEVELOPMENT Capability Model
Assess process capability
Skill checks map your team's upstream, downstream, and scale-up baseline.
Set shared development standards
One playbook for CPPs, CQAs, and stage-gate development work.
Practice in guided labs
Labs cover cell culture, purification, QbD, and scale-up calculations.
Measure the lift
Lab reviews benchmark each employee's bioprocess development capability.
Scale across teams
One standard rolls out across products, sites, and tech transfer teams.
Need more than one program?Get a group quote
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Program Overview: What is Biopharmaceutical Process Development and Scale-Up?
Biopharmaceutical Process Development & Scale-Up Corporate Training is Edstellar's instructor-led program for process scientists and engineers moving molecules toward manufacturing. Across six modules and 24 hours, participants study biopharmaceutical process science, upstream development, and downstream purification. The program covers viral clearance, Quality by Design, process validation, scale-up, and tech transfer.
Training works the scale-up problem directly. Participants design upstream and downstream steps, apply QbD principles to define design space, and plan validation and tech transfer in guided exercises with instructor feedback. Each module confronts the gap between lab success and manufacturing reality. The capstone delivers an end-to-end process development and scale-up plan. Risk review workshops surface the scale-up failure modes teams most often underestimate.
Processes that work at bench scale die at manufacturing scale: uncharacterized parameters, validation planned too late, and tech transfers that read like folklore. This program trains your scientists to develop processes with manufacturing in mind from day one, using QbD to build the understanding that scale-up requires.
The capstone plan takes a molecule from development through manufacturing readiness: process characterization, validation strategy, scale-up risk assessment, and tech transfer documentation, reviewed against regulatory expectations. Instructors probe it for the gaps that stall real filings. Your team returns developing processes that scale instead of processes that surprise.
Six modules and 24 hours: process fundamentals, upstream development, downstream purification, Quality by Design and validation, and scale-up with tech transfer. Every module pairs concepts with a guided lab, so each technique is practiced. It closes with a capstone development and scale-up plan the team builds, calculates, and defends.
Delivery is hybrid across virtual and onsite sessions, scheduled around your calendar. Cohorts train as one group or split into batches, with session materials and lab guides included for every participant.
What's Included in this Workshop for Your Enterprise Teams
- 1
Upstream development labs
Design media, feed, and bioreactor strategies for scale.
- 2
Downstream design exercises
Build purification trains with recovery and purity trade-offs.
- 3
QbD and DoE practice
Map critical attributes and run designed experiments.
- 4
Scale-up engineering
Calculate scale-up parameters and tech transfer packages.
- 5
Capstone plan
Deliver a defended end-to-end development and scale-up plan.
- Instructor-led delivery across virtual, onsite, and hybrid
- Guided labs in every module with instructor coaching
- Capstone development and scale-up plan, reviewed with your team
- Flexible scheduling around your calendar
- Lab guides and process calculation templates included
- Group size and batches set along with you
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
Request a Training Quote- Customized Training Delivery
- Scale Your Training: Small to Large Teams
- In-person Onsite, Live Virtual or Hybrid Training Modes
- Plan from 2000+ Industry-ready Training Programs
- Hands-On Labs on Live Infrastructure, Led by Industry Experts
Biopharmaceutical Process Development and Scale-Up Course Topics and Program Outline
A tailored 24-hour, six-module workshop: one learning journey from process fundamentals to a capstone scale-up plan. Sessions pair concepts with hands-on labs covering real-world use cases. Materials include lab guides and templates, plus a capstone assessment.
Built by Edstellar with bioprocess development engineers
Built by engineers who develop and scale biopharmaceutical processes in production, shaped around your stack and use cases.
Skill checks baseline your team's cell culture, purification, and scale-up fluency before training begins.
Live instruction covers bioprocess fundamentals, upstream and downstream science, and QbD across 6.5 focused hours.
Guided labs build development, characterization, and validation skill across 12 hours of supervised practice.
Your team delivers a capstone development and scale-up plan in 5 hours, defended against engineering and quality criteria.
From process fundamentals to a defended capstone scale-up plan, every technique is practiced in guided labs.
Delivered as
Delivered as a hybrid program of live instruction and guided labs, scheduled around your team's calendar in flexible batches.
Map CPPs and CQAs on a simplified process flow.
learna)How biologics differ from small-molecule drugs
b)Cell lines, media, and growth kinetics basics
c)Upstream operations at a glance: culture and harvest
d)Downstream purification stages at a glance
e)Critical process parameters and product quality attributes
Run a simulated bioreactor scenario and tune feed strategy.
practicea)Media and feed strategy design
b)Bioreactor principles: mixing, oxygen transfer, shear
c)Scale-down models and process characterization
d)High-cell-density and perfusion culture
e)Troubleshooting culture performance drops
Design a purification train with recovery and purity trade-offs.
practicea)Harvest and clarification at scale
b)Capture chromatography: Protein A and alternatives
c)Polishing chromatography sequences
d)Viral clearance filtration and inactivation
e)Designing an end-to-end purification train
Build a risk register and DoE plan for a process step.
practicea)Critical quality attributes, CPPs, and KPPs mapping
b)Risk assessment: FMEA and prior knowledge
c)Design of experiments for characterization
d)Control strategy and proven acceptable ranges
e)PPQ protocols and continued verification
Assemble a tech transfer package for a pilot process.
applya)Scale-up principles and engineering constraints
b)Tech transfer documentation packages
c)Equipment fit and facility readiness checks
d)Deviation, root cause, and CAPA workflows
e)Cost and capacity modeling for campaigns
Deliver and defend a complete process development and scale-up plan.
applya)Capstone brief: product, target yield, timeline
b)Upstream and downstream development plans
c)Scale-up engineering calculations
d)Tech transfer and validation roadmap
e)Final review with instructor panel
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Seven job-ready outcomes your team will demonstrate by the end of the program. Each competency is practiced in guided labs and reviewed in the capstone plan.
Design cell culture strategies
Develop media, feed, and bioreactor strategies that hold yield and quality from development to scale.
Build purification trains
Select and sequence capture and polishing steps with viral clearance to meet purity and recovery targets.
Apply Quality by Design
Map critical quality attributes and process parameters, run risk assessments, and defend a control strategy.
Run designed experiments
Design and interpret DoE studies to characterize processes and set proven acceptable ranges.
Calculate scale-up parameters
Translate lab and pilot data to commercial scale using engineering principles for mixing, oxygen transfer, and residence time.
Execute tech transfer packages
Assemble complete transfer documentation so receiving sites can adopt and run the process reliably.
Defend validation-ready work
Write protocols and evidence packages that withstand internal review and regulatory scrutiny.
Teams that Benefit from this Biopharmaceutical Process Development and Scale-Up Group Training
This group training is built for biopharma teams developing and manufacturing biologics who want robust scale-up discipline without slowing delivery. Content adapts to each cohort's roles, platforms, and experience, so every batch practices the workflows it owns, from characterization to tech transfer.
Develop scalable processes with confidence.
Process development scientists practice upstream and downstream design, DoE characterization, and scale-down modeling so processes perform at pilot and beyond.
Workflow friction
- Processes fail at pilot scale
- Late-stage design rework
- Limited characterization data
How the program helps
- Feed and bioreactor design labs
- DoE characterization workflows
- Scale-down model practice
Practice use cases
- Media design labs
- Purification train drills
- DoE exercises
Receive processes that run right the first time.
MSAT and manufacturing teams learn tech transfer discipline, equipment fit checks, and deviation workflows that keep campaigns on schedule.
Workflow friction
- Weak transfer documentation
- Unplanned deviations at scale
- Capacity planning gaps
How the program helps
- Clean tech transfer packages
- Equipment fit checklists
- Deviation and CAPA drills
Practice use cases
- Transfer package labs
- Fit review practice
- CAPA drills
Build validation-ready development work.
Quality and validation professionals map CQAs and CPPs, build control strategies, and review evidence packages that stand up to scrutiny.
Workflow friction
- Gaps in control strategies
- Inconsistent risk documentation
- Audit findings on validation
How the program helps
- Control strategy templates
- Risk assessment practice
- Evidence review checklists
Practice use cases
- FMEA workshops
- Control strategy labs
- Protocol review drills
Align development with filing and launch needs.
Regulatory and technology operations teams connect development choices to filing expectations and manufacturing readiness across sites.
Workflow friction
- Development out of sync with filings
- Multi-site alignment gaps
- Launch readiness unknowns
How the program helps
- Filing-aligned documentation
- Cross-site readiness reviews
- Timeline planning templates
Practice use cases
- Documentation labs
- Readiness reviews
- Timeline planning
Cohorts train as a cross-functional workforce, with each small group aligned on shared development and scale-up standards.
Prerequisites: Process development scientists, MSAT engineers, and validation professionals benefit most. Familiarity with biologics manufacturing helps but is not required; we refresh fundamentals before advanced work. No prior scale-up experience is needed, and labs adapt to each cohort's molecules, platforms, and tools.
Process Scientist to Bioprocess Development Lead
Tracks how process professionals progress from basic development practice to advanced scale-up ownership across the program's learn, practice, and apply phases.
A program that grows with bioprocess careers, from first development experiments to confident scale-up ownership.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Instructor-led delivery in the format that fits your sites and schedules, with guided labs in every mode.
Hybrid Training
Instructor-led sessions mix onsite and virtual delivery with guided labs throughout. Teams work bioprocess calculations and design exercises while the instructor coaches and reviews results. Hybrid keeps scheduling flexible without losing live interaction.
- Live instruction across onsite and virtual sessions
- Guided labs with instructor coaching and calculation reviews
- Real bioprocess development workflows throughout
- Flexible scheduling without losing live interaction
Onsite Training
Instructor-led training at your offices, with labs set up on your network and tooling. The instructor works with the team in person, reviews design exercises together, and tunes content to your platforms and workflows.
- Instructor-led training at your offices
- Labs set up on your network and tooling
- In-person design reviews and coaching
- Exercises tuned to your platforms and workflows
Live Virtual Training
Live virtual sessions on Zoom or Teams with screen-shared design exercises, breakout labs, and real-time reviews. Your team gets the same guided labs and instructor coaching as onsite, from anywhere.
- Live virtual sessions on Zoom or Teams
- Screen-shared exercises and breakout labs
- Real-time reviews with the instructor
- Same guided labs as onsite, from anywhere
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Learn from industry experts.
Every session is led by a practitioner who has run monitoring for models in production, not a generalist working from slides.
Marlikynti
Machine Learning Trainer in Bengaluru, India
12+ years of Experience
Ajai
Quality Management Systems Trainer in Dubai
12+ years of Experience
Chirag
Chartered Financial Analyst Trainer in Kalyan
5+ years of Experience
Neelam
Time Management Trainer in Pune
9+ years of Experience
Aparajitha
Business Communication Skills Trainer in Gurgaon
4+ years of Experience
Trainers are matched to your stack and delivery window at scheduling. We confirm your assigned trainer, with a full profile, before the program is booked.
Frequently Asked Questions
Share your team size, timelines, and delivery preference, and we will send a detailed per-group quote with batch options.
Yes. Book a discovery call and we will map your molecules, platforms, and goals to a tailored training plan before you commit.
Yes. Live virtual sessions run on Zoom or Teams with the same guided labs and instructor coaching as onsite delivery.
Yes. The instructor runs the full program at your offices, with labs set up on your network and tooling for realistic practice.
The program runs 24 hours of instructor-led training, usually across three to six days or weekly sessions on a flexible, mutually agreed schedule.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
Process development and scale-up follows GMP foundations, so development work is designed with compliant manufacturing in mind. A well-scaled process then moves into biologics production, and cell and gene therapy is the further step for teams working on advanced therapies.
Why Choose Edstellar as Your Biopharmaceutical Process Development and Scale-Up Corporate Training Provider
When comparing providers, Edstellar is the training provider teams choose for bioprocess development expertise and 5+ years of corporate training experience. Our methodology blends concise instruction with guided labs, and we share each trainer profile before booking. The result is development work your manufacturing teams can trust.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Every cohort's labs, calculations, and exercises are tuned to your molecules, platforms, and quality standards.
Proven Methodology
Concise instruction followed by guided labs and design reviews, a repeatable method that turns concepts into scale-ready processes.
Practice-Based Learning
Six modules of guided labs and a defended capstone keep your team calculating and designing, not just listening.
Expert Trainers
Practitioners who develop and scale biopharma processes lead every session and review your team's work.
Global Scale
One consistent program delivered across your sites worldwide, in 10+ languages.
Measurable Outcomes
Lab checkpoints and a capstone defense prove skill gains you can report internally.
Also from Edstellar
Talent assessments
Psychometric, behavioral, leadership and 360-degree assessment.
→Training needs analysis
Needs analysis, gap identification, and a training roadmap.
→L&D consulting
Learning strategy, content, technology and ROI measurement.
→OD consulting
Org design, succession planning and cultural change.
→Managed training services
Training outsourcing, vendor management, logistics and administration.
→Coaching solutions
Executive and manager coaching that keeps skills in use.
Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Biopharmaceutical Process Development & Scale-Up Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request Biopharmaceutical Process Development and Scale-Up Training for Your Team
Share your team size, molecules, platforms, and timelines to receive a tailored training plan and quote. Book a discovery call to discuss your goals; we confirm availability and respond with a proposal.