Formulation and Stability of Advanced Biologics Training Course

Formulation and Stability of Advanced Biologics Training Course

Introduction

The Formulation and Stability of Advanced Biologics training course is designed to equip professionals in the biotechnology and pharmaceutical sectors with cutting-edge knowledge and practical expertise in biologic drug development. In todayΓÇÖs rapidly evolving biopharmaceutical landscape, ensuring the stability, efficacy, and safety of advanced biologics is crucial for both clinical success and regulatory approval. Formulation and Stability of Advanced Biologics Training Course offers an in-depth exploration of biologic formulation strategies, the critical role of stability testing, and the challenges in the long-term storage of biologics such as monoclonal antibodies, gene therapies, and protein-based therapeutics. Participants will gain a thorough understanding of the principles and techniques involved in biologic formulation, encompassing protein stability, excipient compatibility, and analytical methodologies.

With a focus on the latest scientific advancements, this course offers a combination of theoretical frameworks, case studies, and hands-on experience in biologics formulation and stability analysis. This unique training opportunity aims to provide participants with a comprehensive understanding of biologic drug development, ensuring they are equipped with the skills to address real-world challenges in the formulation and stabilization of biologics. Through this course, attendees will master essential concepts such as protein aggregation, cold-chain management, and formulation optimization, while enhancing their ability to navigate regulatory requirements and implement best practices in biologics development.

Course Duration

10 days

Course Objectives

1. Understand the key principles and science behind biologic formulation and stability.
2. Explore the significance of protein stability in biologic drug development.
3. Learn about monoclonal antibodies and their formulation challenges.
4. Master techniques for assessing protein aggregation and stabilization.
5. Grasp the role of excipient compatibility in biologic formulations.
6. Gain practical knowledge of lyophilization techniques for biologic drugs.
7. Understand cold-chain logistics and their impact on biologic stability.
8. Evaluate regulatory guidelines for biologics formulation and stability testing.
9. Examine the role of biologics stability studies in clinical trials and market release.
10. Learn the challenges and solutions for gene therapy formulations.
11. Develop skills for analytical characterization of biologic stability.
12. Understand the emerging technologies in biologic manufacturing and stabilization.
13. Apply case studies to simulate real-world formulation and stability scenarios.

Target Audience

1. Biopharmaceutical Scientists.
2. Regulatory Affairs Professionals.
3. Formulation Chemists.
4. Clinical Trial Managers.
5. Pharmaceutical Engineers.
6. Quality Control Analysts 
7. Research & Development Managers in biopharma.
8. Biotech Entrepreneurs.

Course Modules

Introduction to Advanced Biologics

• Types of biologics 
• The role of biologics in modern medicine
• Differences between biologics and small molecules
• Case studies on Applications in oncology and immunology
• Key challenges in biologic drug development

Protein Stability and Aggregation

• Factors affecting protein stability 
• Mechanisms of protein aggregation 
• Case studies on Techniques to measure aggregation 
• Analytical methods to assess stability 
• Stabilizing agents and their applications

 Formulation Strategies for Biologics

•  Components of biologic formulations
•  Role of excipients in stabilization
•  Compatibility of excipients with biologic molecules
•  Case studies on formulation optimization
•  New trends in biologic formulations

Cold-Chain and Storage Stability

• Importance of temperature control
• Cold-chain management best practices
•  Shipping and storage challenges
•  Long-term stability considerations
•  Case studies on cold-chain failures and solutions

Lyophilization in Biologics

•  Overview of lyophilization techniques
• Freeze-drying and spray drying
•  Lyophilization cycle optimization
•  Stability and shelf life post-lyophilization
•  Case studies on Challenges and solutions in lyophilization

Regulatory Considerations

• Key regulatory bodies and their guidelines
•  Requirements for biologic stability studies
•  Biologic formulation and regulatory submissions
•  Preparing for FDA and EMA evaluations
•  Case studies on Compliance challenges in biologics

Analytical Methods for Stability Testing

• Commonly used stability assays
•  Analytical techniques: HPLC, SEC, DLS
•  Accelerated stability testing
•  Case studies of stability failures
•  Designing stability studies for biologics

Emerging Technologies in Biologic Formulation

• Nanotechnology in biologics
•  Advancements in protein engineering
•  Advanced packaging solutions
•  Case studies on Biotechnology in formulation enhancements
•  Future trends in biologic formulation

Gene Therapy Formulation

• Challenges in gene therapy formulations
• Stability issues in gene delivery systems
• Formulation optimization for gene therapies
• Regulatory landscape for gene therapy
• Case studies in gene therapy formulation

Quality Control and Assurance in Biologics

• QC methods for biologics
• Stability testing in quality control
• Ensuring consistency in biologic formulations
• Case study: QC failures and troubleshooting
• Global quality standards for biologics

Protein Therapeutics and Their Challenges

• Case studies in monoclonal antibodies
• Protein engineering for stability
• Therapeutic protein aggregation issues
• Case studies on Stability of protein-based vaccines
• Solutions for improving protein therapeutic stability

Stability of Recombinant Proteins

• Techniques for assessing recombinant protein stability
• Case studies on Factors influencing recombinant protein quality
• Ensuring functionality of recombinant proteins
• Stability of biologic products during manufacturing
• Real-world case studies of recombinant proteins

Biologics in Clinical Trials

• Role of stability in clinical trials
• Stability study designs for clinical trials
• Impact of stability on clinical data
• Case study: Clinical trial formulation adjustments
• Analyzing clinical data for stability insights

Technological Innovations in Biologic Manufacturing

• Automation in biologic production
• Advances in cell culture and fermentation processes
• Continuous biomanufacturing
• Scale-up challenges in biologic production
• Case studies on New technologies in biologic drug delivery systems

Final Case Study and Review

• Comprehensive case study analysis
• Group discussion on formulation challenges
• Identifying key takeaways from case studies
• Evaluating strategies for overcoming biologic development issues
• Final review of all topics covered

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

• Interactive lectures and presentations.
• Group discussions and brainstorming sessions.
• Hands-on exercises using real-world datasets.
• Role-playing and scenario-based simulations.
• Analysis of case studies to bridge theory and practice.
• Peer-to-peer learning and networking.
• Expert-led Q&A sessions.
• Continuous feedback and personalized guidance.

 Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

 Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.