Inno Biologics, a Malaysian government-backed company, is in the process of assembling the country’s first cGMP modular biopharmaceutical production plant that was shipped from Pharmaplan International, Germany. The facility, which will be finished in mid-2006 and operational by end 2006, is funded by loans and government funds that amount to USD$26 million. The state-of-the art, modular, two-floor biopharmaceutical manufacturing plant will be located at Inno Biologics’ 6,000 m 2 site in Nilai, Negri Sembilan.
The manufacturing plant will enable Inno Biologics to explore new market opportunities in biopharmaceutical production. The plant represents investment of the Malaysian Government in the biotech industry, where it will be able to compete with global players in a field that is highly regulated, technical and requires compliance with international standards.
Inno Biologics Sdn. Bhd. is a subsidiary company of Inno Bio Ventures Sdn. Bhd., a Malaysian Ministry of Finance Incorporated Company with a close affiliation with Malaysian Ministry of Science, Technology and Innovation. Pharmaplan International is a technology service provider and has served pharmaceutical and GMP-oriented industries with plant engineering and implementation. The German company also provides planning for a new plant or optimization of existing production facilities or subsystems.
The modular facility was contracted to an internationally reputed company, Pharmaplan International, to minimize risk of non-compliance with international standards. The biopharmaceutical industry needs to adhere to strict international standards – FDA & EMEA – to be able to provide products and services globally. Inno Biologics’ project, which includes commissioning, construction and delivery of the cGMP plant, was completed in 24 months time including shipping.
The current Good Manufacturing Practice (cGMP) facility was constructed in Germany by a team of skilled specialists, in controlled environments. The various modules were test-run, pre-qualified and inspected before being packaged and shipped to Malaysia and are being reassembled on site at Nilai.
The biotech facility includes Inno Biologics’ headquarters, supporting facilities and laboratories. The new manufacturing plant comprises of 600 m 2 of space spread over two floors. One of the many advantages of the modular construction was that the installation of the new facility caused minimal disruption of the ongoing operations.
Modular design also presents other advantages to Inno Biologics including the flexibility of the facility to grow according to market and industry demands. The new plant is low maintenance, durable and can even be relocated with ease. The installation took just 6 days for the biotech plant with production suits, HVAC, water treatment and all technical features.
Since the focus of Inno Biologics is the production of clinical grade products, the facility is equipped with an adequate 1,000-litre bioreactor. The plant also has provisions for clean room systems, perfusion technology, Hybrid Expanded Bed Adsorption technology and Disposable technology.
The company will employ over 50 people to develop and manufacture biopharmaceuticals including therapeutic proteins and monoclonal antibodies. The plant will enable Malaysia to offer contract manufacturing facilities and other services to pharmaceutical companies, biopharmaceutical companies as well as research institutes for the production of novel biologics for clinical testing.
Inno Biologics’ services encompass gene cloning and expression using CHO cell expression system, bioprocess development and cGMP biopharmaceutical manufacturing. The new plant will facilitate the inclusion of further services from Inno Biologics including biopharmaceutical manufacturing services to local and international pharmaceutical companies. The plant has the capability of producing biosimilar versions of biopharmaceutical blockbuster including interferon-b and granulocyte-macrophage colony stimulating factor (GM-CSF).