Refers to outsourcing drug production to third-party manufacturers. Pharma companies (sponsors) hire CMOs to handle part or all of the manufacturing process, allowing them to focus on R&D, marketing, and distribution.
Advantages of CMOs
Cost Savings – No need to build/maintain factories.
Scalability – Rapid production scaling during demand surges (e.g., pandemics).
Regulatory Expertise – CMOs handle FDA/EMA/GMP compliance.
Advanced Technology – Access to specialized equipment (e.g., lyophilizers for biologics).
Contract Manufacturing
API (Active Pharmaceutical Ingredient) manufacturing involves the synthesis or extraction of the biologically active component in a drug. APIs are the core ingredients that determine a medication’s therapeutic effect (e.g., ibuprofen in painkillers, insulin in diabetes injections).
Key Stages:
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Chemical Synthesis (Small molecules)
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Fermentation/Biotech (Biologics, e.g., antibodies)
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Purification & Isolation
API Manufacturing
Formulation development is the process of designing and optimizing a drug's dosage form (e.g., tablets, injections, creams) to ensure:
Stability Shelf life
Bioavailability How well the drug is absorbed
Patient Compliance Ease of use
Manufacturability Cost-effective production
Formulation Development
The final stage of drug production where Active Pharmaceutical Ingredients (APIs) are converted into market-ready dosage forms (tablets, injections, capsules, etc.). This ensures drugs are safe, effective, and convenient for patients.
Key Objectives:
Ensure accurate dosing
Maintain sterility for injectables
Optimize patient compliance easy-to-use forms
Meet GMP (Good Manufacturing Practice) standards