API Manufacture

Our Services

Our full service approach, highly experienced team and the use of our world class facilities, enables IDT to efficiently take a product from development through to final production.

Each customer project, whether R&D or manufacturing, is assigned a dedicated qualified Project Leader to manage and coordinate all developmental, quality, regulatory, documentary, and manufacturing activities.

API Manufacture

IDT specialises in the development, scale-up, and cGMP manufacture of high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic APIs in compliance with international standards and regulations. We have completed many projects on behalf of multinational clients, demonstrating our expertise and skill in every stage of the process, including the development of HPAPIs for phase I and phase II clinical trials, and the provision of long-term full-scale commercial supply.

Our portfolio includes anti-cancer drugs (specialising in cytotoxics), anti-psychotics, antibiotics, narcotics and anti-inflammatory drugs, and we have built and validated new ‘state-of-the-art’ cGMP manufacturing facilities to accommodate this product range.

Our facilities are dedicated to manufacturing batches of APIs ranging in size from laboratory scale (grams) to multi kilogram commercial scale (up to 250 kg of API per batch) using multistep chemical synthesis. We utilise and maintain cleanrooms of Class 100,000 for product isolation and manufacture. Individual manufacturing plants are located in separate, stand alone suites with their own air handling, vacuum, and heat transfer systems; all activities for products such as manufacture, drying, packaging, and labelling are carried out within the same suites. As the plants have been designed to manufacture several different APIs, we have implemented stringent measures to ensure that cross-contamination is not possible. These measures place emphasis on validated cleaning procedures, including rinse and swabbing techniques.

All of our staff are highly qualified in appropriate scientific areas, and they understand the need to adhere to all relevant standards during drug development and manufacture. The manufacture of pharmaceutical products must comply with the current Good Manufacturing Practices (cGMPs), which ensure that quality is involved with every aspect of manufacture to ensure that the product will always meet defined quality standards.

Our quality systems have been designed to exceed all international regulatory requirements, and have passed scrutiny from various regulatory bodies. This was highlighted by the fact that IDT did not receive any 483 citations when inspected by the FDA in May 1998 and again in 2003. IDT is regularly inspected by the Therapeutic Goods Administration of Australia (TGA) and the US FDA.

As a specialist organisation that has a culture built on the importance of quality, we take pride in the fact that we work as a flexible team, meet tight deadlines and budgets, and continually deliver products and services of the highest standard.

Manufacturing Facilities Overview:

Facility A is a containment facility with a 100 Litre facility for small-scale production of API’s for human and veterinary use;
Facility B contains two plant rooms - an upstairs plant room containing 60 Litre reaction vessels and a downstairs plant room containing 250 Litre reactors. Facility B is a containment facility for the production of anticancer (cytotoxic) APIs. Facility B was commissioned in September 1996 and included as part of an FDA inspection in May 1998. It is used primarily for the manufacture of cytotoxic active ingredients for parenteral use and manufactures cytotoxic products on a scale of between 1 and 10kg. Products manufactured to date include those for the US market and for Phase I and II clinical trials.

Facility B is a containment facility for the production of anticancer (cytotoxic) APIs. It contains two plant rooms - an upstairs plant room containing 60L reaction vessels and a downstairs plant room containing 250L reactors . The facility is segregated into separate rooms for isolation of intermediates and separation of process streams. The plant is extremely versatile and additional vessels can be added depending on the process taking place. Reaction vessels are jacketed, glass-lined stainless steel or jacketed glass vessels. Process pipework, filters and pumps are made from inert materials, and intermediates and final products are isolated in either Nutsche-type filters or centrifuge.

Complex multistage chemical reactions are conducted. Manufacture can be confined to either the small scale plant room or the lower larger scale plant room, or both the upstairs and downstairs reactors can be used simultaneously with product being fed to downstairs from above.

The facility contains a number of additional rooms for product filtration, centrifuging, oven drying, dispensing, packaging and for operator decontamination. The facility is designed with a series of small rooms such that if there is a spillage, it is confined to a small area.
Facility C contains several 2,000 Litre reactors for large-scale production of non-cytotoxic APIs particularly those for parenteral use;
Facility D contains a cleanroom manufacturing area for the small scale production of finished dosage forms for clinical trial use;
Facilities E, K, L and R each contain cleanroom containment facilities designed for manufacture of highly toxic or active materials such as cytotoxics and cephalosporins on a small to medium scale with reactors ranging in size up to 400 Litres;
Facility F is an area dedicated for the manufacture of small scale non-toxic materials;
Facility V is a biological containment facility for the preparation of viral vaccines.
Facility P1 is a containment facility with two manufacturing suites and reactors ranging in size from 100 to 400 Litres.
Facility P2 is a recently-opened large-scale containment facility with reaction vessels at the 4,000 Litre scale.
Facility X is a containment facility currently nearing completion which will provide additional large-scale, high-potency and cytotoxic API manufacturing capability with reactors ranging in size from 800 to 1,250 Litres.

Containment Facilities
IDT currently maintains four specialised containment facilities for manufacturing cytotoxic or other highly potent, toxic materials.

Facility B
Facility B was commissioned in September 1996 and included as part of an FDA inspection in May 1998. It is used primarily for the manufacture of cytotoxic active ingredients for parenteral use and manufactures cytotoxic products on a scale of between 1 and 10kg. Products manufactured to date include those for the US market and for Phase I and II clinical trials.

Facility B is a containment facility for the production of anticancer (cytotoxic) APIs. It contains two plant rooms - an upstairs plant room containg 60L reaction vessels and a downstairs plant room containing 250L reactors . The facility is segregated into separate rooms for isolation of intermediates and separation of process streams. The plant is extremely versatile and additional vessels can be added depending on the process taking place. Reaction vessels are jacketed, glass-lined stainless steel or jacketed glass vessels. Process pipework, filters and pumps are made from inert materials, and intermediates and final products are isolated in either Nutsche-type filters or centrifuge.

Complex multistage chemical reactions are conducted. Manufacture can be confined to either the small scale plant room or the lower larger scale plant room, or both the upstairs and downstairs reactors can be used simultaneously with product being fed to downstairs from above.

The facility contains a number of additional rooms for product filtration, centrifuging, oven drying, dispensing, packaging and for operator decontamination. The facility is designed with a series of small rooms such that if there is a spillage, it is confined to a small area.