Cell and Gene Therapy Manufacturing and Supply Corporate Training
Learn to run cell and gene therapy manufacturing and supply end to end, from donor qualification and cell processing to GMP compliance and vein-to-vein logistics, in live guided labs.
Edstellar, a corporate training company, delivers corporate training that helps your team learn to build reliable cell and gene therapy operations. Your employees develop practical manufacturing skills in instructor-led sessions, working through cell processing workflows, aseptic techniques, cryopreservation plans, and cold chain logistics your business can apply immediately.
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 audit-ready cell and gene therapy team
The Edstellar CELL & GENE THERAPY MANUFACTURING & SUPPLY Capability Model
Assess manufacturing capability
Skill checks map your team's CGT biology, processing, and GMP compliance baseline.
Set shared standards
One shared playbook for cell processing, aseptic operations, and batch documentation.
Practice in guided labs
Labs cover cell processing, transduction, aseptic technique, and cold chain workflows.
Measure the lift
Lab reviews benchmark each employee's CGT manufacturing and supply capability.
Scale across teams
One standard rolls out across manufacturing sites, labs, and supply partners.
Need more than one program?Get a group quote
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Program Overview: What is Cell and Gene Therapy Manufacturing and Supply?
Cell & Gene Therapy Manufacturing & Supply is Edstellar's instructor-led technical program for biopharma manufacturing, quality, and supply chain teams entering advanced therapies. Participants master the CGT production chain: starting materials, cell processing, aseptic manufacturing under GMP, and cryopreserved logistics. The program covers chain of identity, chain of custody, and the QA release that makes a lot shippable.
Training follows a lot from vein to vein. Participants work through donor qualification, cell processing and expansion, and aseptic manufacturing controls in scenario-driven sessions. Instructors coach on GMP documentation, deviation handling, and the cold-chain logistics where CGT products are most vulnerable. The capstone is an end-to-end lot build with QA release: teams manufacture on paper, document everything, and defend the release decision.
CGT manufacturing fails on control, not science: a chain-of-identity break, a temperature excursion nobody caught, documentation that can't support release. This program builds the discipline these therapies demand. Your teams learn that in CGT, the process is the product, and the paperwork proves it.
The lot build capstone takes each team from starting material through processing, fill, cryopreservation, and logistics to a documented QA release decision. Your manufacturing and quality teams return thinking in chains of identity and custody, the mindset that keeps patients safe and lots releasable.
Across instructor-led sessions, employees practice the workflows they own day to day. They review donor eligibility files and chain-of-identity records, simulate cell processing and transduction steps, rehearse aseptic gowning and cleanroom behavior, plan a cryopreserved shipment with validated packaging, and complete batch documentation for a QA release review. The program focuses on the day-to-day work of cell processing teams, quality groups, and supply chain staff, so skills transfer directly to your manufacturing floor, QC labs, and distribution network.
What's Included in this Workshop for Your Enterprise Teams
- 1
CGT foundations
Modalities, vectors, and autologous versus allogeneic workflows.
- 2
Starting material
Donor qualification, collection, and chain of identity.
- 3
Cell processing
Isolation, transduction, expansion, and in-process controls.
- 4
GMP compliance
Aseptic operations, environmental monitoring, deviations.
- 5
Supply and logistics
Cryopreservation, cold chain, and vein-to-vein coordination.
- 6
Capstone release
A full lot build with QA review and release documentation.
- Instructor-led sessions in hybrid, onsite, or live virtual format
- Guided hands-on labs with simulated CGT manufacturing datasets
- Chain-of-identity, batch record, and shipment templates
- Capstone lot build and QA release review with instructor feedback
- Course materials and lab workbooks for every participant
- Post-training support for rollout questions
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
Cell and Gene Therapy Manufacturing and Supply Course Topics and Program Outline
A hands-on learning path that moves from therapy foundations and starting material into cell processing, GMP manufacturing, cold chain logistics, and a full capstone lot release.
Built by Edstellar with cell and gene therapy manufacturing practitioners
Built by practitioners who run CGT manufacturing, QC, and supply operations in regulated facilities, shaped around your stack and use cases.
We benchmark your team's CGT manufacturing, GMP, and supply chain skills to tailor the labs to your reality.
Foundations: therapy modalities, vectors, donor qualification, and chain of identity across 6 hours.
Guided labs on cell processing, aseptic operations, batch records, and cold chain using real-world scenarios.
A 5-hour capstone lot build where your team manufactures, documents, and releases a full CGT lot.
Six guided labs and one capstone build real CGT manufacturing muscle across 24 hours of instructor-led practice.
Delivered as
Delivered in hybrid, onsite, or live virtual formats, with every module anchored in hands-on labs.
Map a CAR-T and an allogeneic product onto their end-to-end workflows, noting where manufacturing and supply risks differ.
learna)Cell therapy, gene therapy, and combination product modalities
b)Viral and non-viral vector systems: lentiviral, AAV, and plasmid platforms
c)Autologous versus allogeneic workflows and their supply implications
d)Product types: CAR-T, TIL, stem cell, and in vivo gene therapies
e)The regulatory landscape: FDA, EMA, and GMP expectations for CGT
Review a mock donor eligibility file and trace chain-of-identity records from collection to manufacturing receipt, flagging any gaps.
learna)Donor eligibility criteria and screening workflows
b)Apheresis collection: process overview and collection site roles
c)Chain of identity and chain of custody documentation
d)Infectious disease testing and donor test result interpretation
e)Starting material transport and receipt at manufacturing sites
Walk through a simulated transduction and expansion run, calculating vector doses and reviewing in-process control data for out-of-trend results.
practicea)Cell isolation and enrichment from apheresis material
b)Cell activation and culture initiation practices
c)Transduction with viral vectors and non-viral delivery methods
d)Expansion, harvest, and formulation operations
e)In-process controls, sampling, and process data review
Complete a simulated batch record section and write up a mock deviation, practicing the documentation detail QA expects.
practicea)GMP principles applied to CGT manufacturing facilities
b)Gowning, cleanroom behavior, and aseptic technique fundamentals
c)Environmental monitoring: viable and non-viable programs
d)Deviations, investigations, and CAPA workflows
e)Batch documentation practices that survive QA review and audit
Plan a cryopreserved shipment end to end, selecting packaging, mapping custody handoffs, and drafting the excursion response plan.
practicea)Cryopreservation principles and controlled-rate freezing
b)Cryogenic storage, inventory control, and temperature excursion response
c)Validated packaging and cold chain shipment qualification
d)Chain-of-custody during transport and customs handling
e)Clinical site coordination: scheduling, thawing, and infusion handoff
Execute the full capstone lot build and defend the lot in a QA release review with instructor feedback on every record.
applya)Integrated lot build: from starting material to formulated product
b)Batch record completion and data integrity checks
c)Release testing overview: sterility, identity, potency, and purity
d)QA review and the lot release decision process
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
Practical cell and gene therapy manufacturing competencies your employees build through guided labs and the capstone lot release, ready to apply in your facility.
Explain CGT modalities, vectors, and product types
Describe how cell and gene therapies differ by modality, vector, and manufacturing pathway.
Qualify donors and manage chain of identity
Screen donor eligibility, review collection records, and keep chain-of-identity documentation complete.
Operate cell processing and expansion steps
Run isolation, activation, transduction, and expansion workflows with in-process controls.
Work aseptically and document under GMP
Apply cleanroom discipline, environmental monitoring awareness, and audit-ready batch documentation.
Manage cryopreservation and cold chain logistics
Plan freezing, storage, validated shipping, and temperature excursion responses across the vein-to-vein chain.
Coordinate clinical site handoffs
Schedule deliveries, align with treatment sites, and support thawing and infusion handoffs.
Support batch review and lot release
Compile batch records and release data so QA can make the lot release decision confidently.
Teams that Benefit from this Cell and Gene Therapy Manufacturing and Supply Group Training
Cell processing teams, quality and GMP staff, supply chain groups, and clinical operations professionals who own manufacturing, compliance, or logistics for advanced therapies will gain the most. Content adapts to each cohort's roles, facilities, and experience level, so every team practices the workflows it owns.
Run cell processing lines with consistent quality
Cell processing teams learn isolation, transduction, expansion, and in-process controls so every lot runs to the same standard.
Workflow friction
- Inconsistent processing across shifts and sites
- Deviations found late in the batch record
- Knowledge gaps on vector handling and dosing
How the program helps
- Standardize cell processing and expansion steps
- Catch process deviations during the run, not after
- Build lots that pass QA review first time
Practice use cases
- Transduction labs
- Expansion runs
- In-process control reviews
Keep CGT operations audit-ready every day
QA and QC teams practice aseptic oversight, environmental monitoring, and deviation handling so records survive regulatory review.
Workflow friction
- Batch records returned for missing detail
- Deviation investigations that stall at root cause
- Environmental monitoring trends acted on late
How the program helps
- Strengthen batch documentation and data integrity
- Handle deviations and CAPA with GMP discipline
- Prepare sites for inspections with confidence
Practice use cases
- Deviation write-ups
- Batch record labs
- Audit readiness reviews
Protect every lot across the vein-to-vein chain
Supply teams plan cryopreservation, validated shipping, and custody handoffs so product integrity holds from facility to patient.
Workflow friction
- Excursion events with no clear response plan
- Shipment delays risking product viability
- Custody gaps between manufacturing and clinics
How the program helps
- Qualify cold chain packaging and shipping lanes
- Respond to temperature excursions by the book
- Coordinate clean handoffs with clinical sites
Practice use cases
- Shipment planning labs
- Excursion response drills
- Custody handoff mapping
Connect manufacturing output to patient treatment
Clinical operations and cell collection teams align on scheduling, collection quality, and site handoffs so treatments start on time.
Workflow friction
- Starting material rejected on quality grounds
- Collection and manufacturing schedules misaligned
- Site staff unclear on product handling needs
How the program helps
- Improve collection quality for manufacturing
- Align site schedules with manufacturing slots
- Smooth thawing and infusion handoffs
Practice use cases
- Collection quality labs
- Site scheduling practice
- Handoff coordination
Cohorts can mix functions or stay single-team; labs adapt to the products and workflows your team runs.
Prerequisites: This program benefits cell processing teams, quality and GMP staff, and supply chain groups most, whether they are new to advanced therapies or experienced operators. Comfort with regulated manufacturing documentation helps in the labs, but no prior CGT experience is needed. We adapt examples, datasets, and the capstone to your team's products, facilities, and workflows.
Process Associate to CGT Manufacturing Lead
New process associates build CGT literacy from the foundations up, while experienced operators and QA staff sharpen manufacturing, compliance, and supply skills through the capstone lot release.
One program that grows with advanced therapy careers, from CGT basics to confident, audit-ready manufacturing practice.
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
Choose the format that fits your manufacturing calendar and team locations. Every mode includes the same instructor-led labs and capstone lot build.
Hybrid Training
Blend onsite and live virtual sessions so distributed manufacturing and supply teams learn together without halting production for a full week.
- Live instructor with hands-on lab facilitation
- Same datasets and templates for all participants
- Capstone lot build presented to your stakeholders
- Scheduling around production and shipping windows
Onsite Training
Bring the instructor to your facility for intensive, focused sessions where teams work on your products and processes side by side.
- Instructor-led labs at your facility
- Workshops built around your products and SOPs
- Team-based capstone with peer review
- Direct coaching during every lab session
Live Virtual Training
Join live virtual sessions with a real instructor, shared screens, and breakout labs, ideal for teams across manufacturing sites.
- Live virtual instructor, not recorded videos
- Guided labs with screen sharing and feedback
- Digital templates for batch records and shipment plans
- Capstone presented in a virtual release review
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.
Frequently Asked Questions
Share your team size, preferred dates, and delivery format through the request form. A training advisor responds within one business day with a tailored plan and group quote.
Yes. A short discovery call helps us understand your products, team roles, and goals so we can tailor the labs and capstone to your operation.
Yes. Live virtual sessions run with a real instructor, shared screens, and breakout labs, so distributed CGT teams get the same hands-on practice.
Yes. Onsite delivery brings the instructor to your facility for intensive sessions built around your products, SOPs, and manufacturing calendar.
The program runs 24 hours of instructor-led training across 6 modules, including 6 guided labs and a 5-hour capstone lot build and release.
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.
Cell and gene therapy manufacturing builds on GMP and biologics experience, since these therapies add patient-specific processes on top of familiar biomanufacturing. Your team then manages the cold chain, which these products depend on from collection to infusion.
More related courses
Why Choose Edstellar as Your Cell and Gene Therapy Manufacturing and Supply Corporate Training Provider
Edstellar is a training provider for teams that builds healthcare manufacturing capability through instructor-led, hands-on programs. With 5,000+ certified trainers and 2,000+ courses, we help cell processing, quality, and supply chain teams run reliable, audit-ready advanced therapy operations.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Labs and the capstone use your therapy products and facility workflows, so every exercise mirrors your team's actual work.
Proven Methodology
Training follows GMP-aligned CGT manufacturing practice, from donor qualification and processing to batch documentation and release.
Practice-Based Learning
Six guided labs and a capstone lot build put transduction, aseptic technique, batch records, and shipment plans in your team's hands.
Expert Trainers
Instructors are CGT practitioners who have run manufacturing, QC, and supply operations in regulated facilities.
Global Scale
Multi-cohort rollouts across manufacturing sites keep content consistent while localizing to each facility's products and SOPs.
Measurable Outcomes
Lab reviews and the graded capstone show exactly how far each participant's CGT manufacturing capability has advanced.
Connect Cell and Gene Therapy Manufacturing with Identity and Supply Controls
Our cell and gene therapy training follows a lot through starting-material review, processing, documentation, and delivery. Participants compare product workflows, examine identity records, and plan a cryopreserved shipment before a simulated release review. The emphasis is on traceable records and justified quality questions, with exercises distinct from actual manufacturing authorization or clinical decisions.
- Step 01
Consult
We review your processing, quality, and supply responsibilities, identifying learning needs in product workflows, donor records, chain of identity, GMP documentation, and cold-chain handoffs.
- Step 02
Plan
We establish therapy modalities before starting-material review, simulated processing, aseptic documentation, and shipment planning, culminating in the mock lot and QA review.
- Step 03
Align
We connect cell-processing, quality, and logistics perspectives, adapting manufacturing foundations and confirming that biological operations and release decisions remain within supervised simulation.
- Step 04
Customize
We tailor fictional donor files, batch records, and shipment scenarios to representative autologous or allogeneic workflows, making identity and custody checkpoints explicit.
- Step 05
Execute
Participants trace identity records, review in-process trends, document a deviation, and plan excursion response with feedback on completeness and the consistency of handoff evidence.
- Step 06
Evaluate
We assess the mock lot for traceable identity, coherent process and deviation records, justified cold-chain decisions, and clearly documented questions for qualified release review.
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?
Cell & Gene Therapy Manufacturing & Supply Training 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 Cell and Gene Therapy Manufacturing and Supply Training for Your Team
Tell us about your team size, products, preferred dates, and delivery format. We will shape the labs and capstone around your manufacturing operation.