Variuos types of API Developed by CRO:-

What are the various types of ApI developed by CRO

CROs (Contract Research Organizations) develop various types of APIs (Active Pharmaceutical Ingredients) for pharmaceutical, biotechnology, and generic drug companies. Here are some examples:

*Small Molecule APIs:*

1. Chemical synthesis APIs

2. Fermentation-based APIs

3. Semi-synthetic APIs

4. Chiral APIs

5. High-potency APIs (HPAPIs)

*Biologic APIs (Large Molecules):*

1. Monoclonal antibodies (mAbs)

2. Recombinant proteins

3. Vaccines

4. Gene therapies

5. Cell therapies

*Peptide APIs:*

1. Solid-phase peptide synthesis (SPPS)

2. Solution-phase peptide synthesis

3. Hybrid peptide synthesis

4. Peptide conjugates

*Sterile APIs:*

1. Injectable APIs

2. Ophthalmic APIs

3. Inhalation APIs

4. Sterile lyophilized APIs

*Niche APIs:*

1. Highly potent APIs (HPAPIs)

2. Cytotoxic APIs

3. Radiolabeled APIs

4. Nanoparticle-based APIs

*Complex APIs:*

1. Prodrugs

2. Prodrug-soft drug combinations

3. Drug conjugates

4. Polymeric APIs

*Innovative APIs:*

1. Targeted therapies

2. Immunotherapies

3. Gene editing technologies (e.g., CRISPR)

4. RNA-based therapies

*Generic APIs:*

1. Patent-expired APIs

2. Biosimilar APIs

3. Generic versions of innovator APIs

*Other APIs:*

1. Veterinary APIs

2. Nutraceutical APIs

3. Cosmeceutical APIs

4. Pharmaceutical intermediates

CROs develop APIs using various technologies:

1. Chemical synthesis

2. Fermentation

3. Biotechnology (e.g., recombinant DNA)

4. Enzymatic synthesis

5. Crystallization

CROs also provide analytical and regulatory services:

1. API characterization

2. Method development and validation

3. Stability studies

4. Regulatory documentation (e.g., DMF, CMC)