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Viral Vectors, mRNA and Lipid Nanoparticle Manufacturing Course & Certification
Intermediate
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3 hours
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Viral Vectors, mRNA and Lipid Nanoparticle Manufacturing
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About
Viral vectors, messenger RNA (mRNA), and lipid nanoparticle (LNP) technologies are at the forefront of modern biologics, vaccines, and advanced therapies. Their manufacture requires highly controlled GMP processes, specialised facilities, robust analytical methods, and comprehensive Chemistry, Manufacturing and Controls (CMC) strategies to ensure product quality, safety, efficacy, and regulatory compliance throughout the product lifecycle.
This GMP – Viral Vectors, mRNA and Lipid Nanoparticle Manufacturing Training Course & Certification provides comprehensive knowledge of viral vector manufacturing platforms, upstream and downstream processing, mRNA drug substance production, lipid nanoparticle formulation, analytical testing, potency assays, contamination control, GMP facility design, biosafety, process validation, technology transfer, stability programmes, CMC documentation, regulatory expectations, and lifecycle management for advanced biologic products. Upon successful completion, learners receive a certification demonstrating their understanding of GMP manufacturing principles and regulatory best practices for viral vectors, mRNA, and lipid nanoparticle-based therapeutics.
Who Should Enrol?
- Biopharmaceutical Manufacturing and Operations Professionals
- Cell and Gene Therapy Manufacturing Personnel
- Process Development and Manufacturing Scientists
- Quality Assurance and Quality Management Professionals
- Analytical Development and Quality Control Scientists
- Regulatory Affairs and CMC Professionals
- Validation, Technology Transfer, and Engineering Teams
- Anyone involved in the development, manufacture, quality, or regulatory oversight of viral vector, mRNA, or lipid nanoparticle products
What you will learn
Understand the principles of GMP manufacturing for viral vectors, mRNA therapeutics, and lipid nanoparticle (LNP) drug products, including key regulatory and quality requirements.
Learn how viral vectors and mRNA are developed, manufactured, purified, formulated, and controlled, together with the critical quality attributes that ensure product safety and efficacy.
Develop knowledge of upstream and downstream processing, LNP formulation, analytical testing, potency assays, process validation, contamination control, and technology transfer.
Gain practical understanding of GMP facilities, biosafety, quality risk management, stability studies, CMC documentation, regulatory submissions, and lifecycle management for advanced biologic products.
Course Syllabus
- Three platforms, one manufacturing logic
- Viral vectors: shared design concepts
- Vector genome, capsid/envelope and payload
- In vivo versus ex vivo use
- mRNA platforms: conventional, self-amplifying and emerging designs
- Anatomy of an mRNA molecule
- LNP components and roles
- Encapsulation, cellular delivery and drug-product role
- Platform quality-risk comparison
- Drug substance versus drug product: worked classification
- Vectra's platform portfolio
- Production systems overview
- Suspension versus adherent; fixed-bed and bioreactor concepts
- Cell and virus seed systems
- AAV manufacturing: high-level upstream flow
- AAV harvest, lysis and clarification
- AAV purification principles and the empty/full challenge
- Lentiviral and retroviral manufacturing: producer cells and plasmid systems
- Lentiviral/retroviral: harvest, purification and safety testing
- Other vector platforms: adenoviral and oncolytic concepts
- Materials and controls across viral-vector platforms
- In-process controls
- Vectra: selecting a vector platform for a new programme
- Downstream objectives
- Removal of plasmid and process impurities; concentration and buffer exchange
- Yield, purity and infectivity trade-offs
- Purification technologies: filtration concepts
- Chromatography modes at a high level
- Ultrafiltration/diafiltration and nuclease treatment concepts
- Closed processing and single-use systems
- Formulation: stability, aggregation and excipient selection
- Container-closure considerations and freeze-thaw risk
- Aseptic processing: bioburden, sterile filtration and filling
- Contamination control strategy and container-closure integrity
- Vectra: fill-finish risk assessment for a second site
- DNA template: concepts and control
- In vitro transcription (IVT)
- Capping and poly(A) strategies
- Process consistency across capping approaches
- Purification: removing DNA template, enzymes and nucleotides
- Removal of double-stranded RNA and truncated species
- Chromatography and filtration principles for mRNA
- Concentration and buffer exchange
- mRNA critical quality attributes: identity through cap efficiency
- mRNA critical quality attributes: purity, activity, bioburden and endotoxin
- Scale-up, closed processing and RNase control
- Vectra: an mRNA target change using platform prior knowledge
- Lipid components and their roles
- Lipid quality and impurity control
- LNP formation principles
- Scale dependence and mixing consistency
- Post-formation processing
- Drug-product CQAs: particle and payload attributes
- Drug-product CQAs: potency, physicochemical and degradation attributes
- Fill-finish and storage
- Freeze-thaw, agitation sensitivity and device compatibility
- Vectra: lipid supplier change and an adduct stability signal
- Viral-vector analytics: titre and empty/full assessment
- Viral-vector analytics: identity, purity and safety
- mRNA analytics: identity, integrity, cap and poly(A)
- mRNA analytics: residual impurities, purity and functional activity
- LNP analytics: particle and encapsulation attributes
- LNP analytics: potency, free RNA and adducts
- Analytical lifecycle: development and reference materials
- Validation, transfer and stability-indicating methods
- Designing a release panel
- Potency strategy
- Vectra: investigating an out-of-trend analytical result
- Facility concepts: segregation and campaigning
- Personnel and material flows; air handling concepts
- Warehouse and cold storage
- Contamination control: microbial and RNase control
- Environmental monitoring, cleaning and single-use integrity
- Biosafety and GMO controls
- Waste, environmental assessment and occupational safety
- Data and automation: EBR, process control and data integrity
- Computerised system assurance
- Scale-up: mixing and mass-transfer considerations
- Manufacturing-site transfer, method transfer and raw-material changes
- Engineering and demonstration batches
- Comparability: predefined analytical plan and process-performance evidence
- Nonclinical/clinical bridging and platform knowledge limits
- Validation: process characterisation, PPQ and continued process verification
- Aseptic-process validation, shipping/hold-time studies and cleaning validation
- Stability: platform-specific degradation pathways
- Container-closure integrity, freeze-thaw and in-use stability
- Regulatory CMC: IND/IMPD expectations and CTD Module 3
- Specifications, viral safety and mRNA/RNA-medicine guidance
- Post-approval change management
- Vectra: mapping a technology transfer to the CTD
- 📘 Bonus:Viral Vectors, mRNA and Lipid Nanoparticle Manufacturing eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with developments in viral-vector, mRNA and lipid-nanoparticle manufacturing guidance, including FDA cellular and gene therapy guidance, EMA ATMP and mRNA quality guidelines, and ICH quality guidelines, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by specialists in viral-vector, mRNA and lipid-nanoparticle manufacturing and regulatory CMC to ensure that learners can apply platform-appropriate quality and manufacturing-strategy thinking in their own organisations.
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