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Biologics and Biotech Manufacturing Fundamentals Course & Certification
Intermediate
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4.7
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3 hours
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Biologics and Biotech Manufacturing Fundamentals
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About
Biologics and Biotech Manufacturing Fundamentals training provides a comprehensive introduction to the science, manufacturing processes, quality systems, and regulatory principles that support the development and production of biologic medicines. It helps learners understand how biologics are produced using living systems and how quality, safety, efficacy, and compliance are maintained throughout the product lifecycle.
This Biologics and Biotech Manufacturing Fundamentals Course & Certification provides essential knowledge on biologic product characteristics, cell banking, upstream and downstream processing, viral safety, formulation development, aseptic manufacturing, analytical testing, quality control, Quality by Design (QbD), technology transfer, contamination control, and GMP-compliant manufacturing practices. Upon successful completion, learners receive a certification demonstrating their understanding of biologics manufacturing fundamentals and industry best practices.
Who Should Enrol?
- Biopharmaceutical Manufacturing and Production Personnel
- Quality Assurance (QA) and Quality Control (QC) Professionals
- Process Development and Manufacturing Science Staff
- Validation, Technology Transfer, and Engineering Professionals
- Regulatory Affairs and Compliance Personnel
- Research Scientists and Laboratory Professionals
- Students and Graduates Entering the Biopharmaceutical Industry
- Anyone seeking a foundational understanding of biologics and biotech manufacturing
What you will learn
Understand the principles of anti-bribery and anti-corruption, key legal requirements, and the risks associated with unethical business practices.
Learn the roles and responsibilities of employees, managers, business partners, and organizations in preventing bribery and corruption.
Develop knowledge of gifts and hospitality, conflicts of interest, facilitation payments, third-party due diligence, and reporting mechanisms.
Gain understanding of compliance controls, investigations, whistleblowing procedures, and best practices for maintaining an ethical and transparent business environment.
Course Syllabus
- Context — Biologics vs small molecules
- Audience — Who this course is for
- Outcomes — What you'll be able to do
- Roadmap — The eight modules
- How you'll learn
- Case study — Northlake Biologics Ltd
- Biologics landscape — mAbs, recombinant proteins, vaccines, biosimilars
- Molecular and product complexity
- Post-translational modifications and glycosylation
- Quality attributes — identity, purity, potency, safety
- Case Study — Northlake's modality and CQA choices
- Small molecule vs biologic comparison
- Host cell systems — mammalian, microbial, yeast, insect
- Master and working cell banks
- Raw materials, media and single-use components
- Viral and microbial safety strategy
- Case Study — CHO cell-line and raw-material variability
- Cell-bank lifecycle map
- Seed train and inoculum concepts
- Batch, fed-batch and perfusion bioreactor operations
- Process monitoring and scale-up principles
- Harvest and clarification
- Case Study — Fed-batch development and scale-up risk
- CPP selection scenario
- Impurity landscape — HCP, HCD, viruses, aggregates
- Affinity capture and polishing chromatography
- Filtration, concentration and viral clearance
- Yield, purity and pool criteria
- Case Study — Affinity capture and a viral-clearance study
- Chromatography selection scenario
- Formulation principles and protein stability
- Aseptic fill-finish and lyophilisation concepts
- Container closure and extractables/leachables
- Administration and in-use stability
- Case Study — High-concentration formulation and prefilled syringes
- Container-closure selection exercise
- Analytical methods and quality attributes
- Specifications — release vs stability
- Method lifecycle and reference standards
- Stability, degradation and comparability
- Case Study — A host-cell-protein trend
- Specification justification exercise
- Facility design and personnel/material flow
- Contamination control and environmental monitoring
- Quality systems — deviations, CAPA, change control
- Process validation and continued verification
- Case Study — GMP and contamination-control response
- Deviation investigation exercise
- QTPP, CQAs, CMAs and CPPs
- Technology transfer and commercial readiness
- Regulatory CMC and CTD Module 3
- Continued process verification and continuous improvement
- Case Study — Technology transfer and comparability
- QTPP-to-CQA workshop
- Course Conclusion — Bringing It All Together
- Consolidating Biologics Modalities
- Cell Banks and Materials Recap
- Upstream Processing Recap
- Downstream Purification Recap
- Formulation and Fill-Finish Recap
- Analytics and Stability Recap
- GMP and Validation Recap
- QbD, Transfer and Lifecycle Recap
- Common Manufacturing Failures to Avoid
- Integrated Case Study Recap: The Full Northlake Biologics Ltd Journey
- Action Plan & Final Assessment Preparation Guidance
- Course completion
- 📘 Bonus:Biologics and Biotech Manufacturing Fundamentals 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 any changes to ICH quality guidelines (Q5A-Q5D, Q6B, Q8-Q12), EU GMP Annex 1 and Annex 2, and FDA/WHO biologics manufacturing guidance, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed to reflect current biologics manufacturing, quality and GMP practice, so learners can engage confidently with cell-bank, upstream, downstream, formulation, analytical, quality-system and lifecycle discussions in their own organisations.
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