Report of Seminar 18th

September 2015

Name : Inggit Kresna Maharsih

Student ID : 104324602

Department : Chemical and Materials Engineering

Topic : API Chemcal Process and Scale-up

Speaker : Mr. Lien, ScinoPharm Taiwan, Ltd.

I. Purpose of Seminar

1. Recognize pharmaceutical industry

2. Recognize the process of pharmaceutical industry

3. Recognize ScinoPharm Ltd.

II. General Explanation about Medicine

In general, medicine is made from a mixture of API (Active Pharmaceutical Ingredients) and

excipient. API is an active compound or key intermediate in drug products, while excipient is

assisted agent for drug delivery.

API + excipient drug product

III. Typical API Process

For scaling-up the API process, there are several considerations that must be known to

reproducibly provide the same chemical outcome as that from lab bench scale. They are safety,

plant fit, material handling, waste treatment, heat transfer, mixing index and impeller design, and

also crystallization.

IV. Manufacturing of Drugs

Pharmaceutical industries mostly use batch reactor. In this reactor, time is an important factor.

Common processing steps for all three routes including feeding, blending and tableting. The dry

granulation routes involves roller compaction followed by milling of the produced ribbons while

the wet granulation route involves wet granulation followed by drying and then granule milling.

There is no granulation step in direct compaction and therefore milling is not required prior to

tableting (Rogers, Hashemi and Ierapetritou, 2013).

Manufacturing process of drug (Rogers, Hashemi and Ierapetritou, 2013)

V. Company Overview (ScinoPharm Taiwan, Ltd.)

1. ScinoPharm Missions

a. Maintain dominant position in specialty API for generic market.

b. Provide API custom synthesis services to new drug development and brand

companies.

c. Supplying small molecules, peptides, biopharmaceutical services.

2. ScinoPharm Overview

a. Established in 1997 in Taiwan by founders from Syntex, listed on TWSE (1789).

b. Major investors include Uni-President Group, Government’s Development Fund,

Taiwan Sugar, etc.

c. Facility and organization designed and built in Taiwan by experienced Syntex

team, received multiple regulatory inspections from US FDA, Australia, EU,

Japan, etc.

d. Specialized in high potency (steroid and cytotoxic) and injectable APIs.

e. Expanding in China with a new plant in Changshu, while sales and marketing

base in Shanghai

3. Global API Market Overview

a. API market is estimated around $ 130 billion in 2014 and expected to grow at

CAGR 7% from 2011 to 2016.

b. The global HPAPI market is valued at US$ 8.9 billion in 2011, growing at a

CAGR of 8.3% till 2016.

c. The global API market revenue was dominated by synthetic APIs (82.7%) in

2011 wherein the biotech API is expected to expand from 17.3% to 23.6% in

2015.

4. Global API Suppliers

a. Including starting materials, intermediates and APIs, there are >8000 suppliers

worldwide.

b. At about 300 independent suppliers/facilities have passed FDA inspection also

with active DMFs.

c. At about 30 capable of handling oncological injectable APIs.

d. Market is quite fragmented with the largest supplier occupying less than 4% of

the total market.

5. Generic Drugs

a. Drug approval- The Hatch-Waxman Act NDA (New Drug Application) vs

ANDA.

b. Generics-containing the same API as the ref drug. By definition, generics are

identical or bioequivalent to the brand drug with respect topharmacokinetic and

pharmacodynamics properties.

c. Generic applicant-ANDA-BA/BE studies.

d. API manufacturer-DMF filing.

VI. Related Reference

Amanda J. Rogers, Amir Hashemi and Marianthi G. Ierapetritou, Modeling of Particulate

Processes for the Continuous Manufacture of Solid-Based Pharmaceutical Dosage Forms,

Processes (2013) 1: 67-127.