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Quality Learners - Dev Challenges - API 08dec2024

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25 views16 pages

Quality Learners - Dev Challenges - API 08dec2024

Uploaded by

raamesh4u
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Development Challenges of Active Pharmaceutical

Ingredient
Understanding of Development Complexities

Sanjay Gade
Director – Proexp Pharma Pvt. Ltd.
08-Dec-2024
Introduction

Definition of APIs
• Active Pharmaceutical Ingredients are the active components in a drug that
produce the intended therapeutic effects.
• Routes - Chemical synthesis, Biological, fermentation, recombinant DNA,
isolation from natural sources, and combinations of these processes.
Importance of APIs
• Ensures efficient, scalable, and reproducible production of APIs.
• Essential for improving efficiency and reducing costs.
• Core to drug formulation, quality, efficacy and safety.
Development Challenges

• Technical Challenges

• Economic Challenges

• Quality Control and Assurance

• Environmental, Health, Safety and Sustainability Issues

• Regulatory Challenges
Technical Challenges

Synthesis Complexity
• Multi-step synthesis with varying reaction, work up and isolation unit operations
often required.
Yield and Purity
• Achieving high yield while maintaining purity can be difficult.
Reaction Optimization
• Continuous optimization of CPP, CMAs and key RM quantities required for
efficient processes.
Scalability
• Laboratory-scale methods may not translate to large-scale production including
heat transfer and mixing inefficiencies.
Technical Challenges
Stability
• Ensuring API stability during production, storage, and distribution.
Innovative Technologies
• Need for continuous R&D in synthesis technologies and methods.
Economic Challenges
High Development Costs
• Significant investment in R&D and manufacturing.
Cost and Availability of Raw Materials
• Availability and fluctuating prices of raw materials can impact production costs.
Market Competition:
• Price pressures from generic manufacturers while maintaining quality affect
profitability.
Market Fluctuations
• Financial risks due to changes in demand and supply affecting feasibility
Time-to-Market:
• Delays in development can lead to lost market opportunities
Economic Challenges
Supply Chain Issues:
• Global disruptions can lead to increased costs and delays.
• Strategies to handle supply chain disruptions
Intellectual Property:
• Navigating existing patents while protecting innovations can be legally
challenging.
• Patent challenges and the need for strong IP protection.
Quality Control and Assurance
Quality Control Protocols:
• Establishing rigorous QC measures to ensure API quality.
Quality Standards:
• Air/Oxygen/Light sensitive raw materials, intermediates, etc., leading to precise control of
impurities
• Adherence to strict quality control measures to ensure API quality is mandatory.
Analytical Techniques:
• Need for advanced analytical methods to monitor process performance.
Testing and Validation:
• Comprehensive validation required for all critical steps.
• Extensive testing required for safety and efficacy.
Quality Control and Assurance
Batch Consistency:
• Maintaining consistency across production batches can be challenging.
Technological Integration:
• Need for advanced analytics and technologies in quality assurance.
Environmental, Health Safety and Sustainability Issues

Environmental Regulations:

• Increasingly stringent regulations on waste disposal and emissions.

Health and Safety Regulations:

• Safety concerns, use of thermally unstable, friction/shock sensitive, hazardous materials.

• Ensuring safety standards for personnel and assets during production.

Waste Management:

• Effective strategies for managing chemical waste and byproducts

Sustainable Practices:

• Need to adopt green chemistry and engineering principles in API development.


Environmental, Health Safety and Sustainability Issues

Resource Management:

• Efficient use of resources to minimize environmental impact.

Public Perception:

• Growing consumer demand and regulatory pressures for environmentally friendly and
sustainable practices.
Regulatory Challenges

Complex Regulations:
• Vary by region (FDA, EMA, ICH guidelines).
Documentation:
• Extensive documentation needed for all stages of process development.
Compliance:
• Continuous updates require constant vigilance and adaptation.
Approval Processes and Timelines:
• Lengthy and resource-intensive, delaying time to market.
Risk Management:
• Thorough risk assessments are necessary for process changes.
Risk of Non-compliance:
• Severe penalties, product recalls, or bans.
Path Forward

Innovative Technologies:

o Adoption of novel process technologies, QbD, design, simulation and modelling software,
automation, AI, and machine learning to enhance process development.

Collaboration:

o Partnerships between academia and industry for knowledge sharing.

Focus on Sustainability:

o Incorporating green chemistry, engineering and sustainable practices into development


processes.

Regulatory Adaptation:

o Staying ahead of regulatory changes to ensure compliance.


Closing Thoughts

Summary of Challenges:

• Technical, economic, quality, environmental and Regulatory challenges.

Importance of Addressing Challenges:

• Effective management of these challenges is essential for successful API development.

• Encourage collaborative approaches and efforts to address these challenges through cross
functional, industry and academia partnerships.
Questions and Discussion

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