FAQs

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FAQs- General
FAQs- Technology Transfer Center (TTC)





FAQs - General

Who is Hovione?
Hovione is an international company dedicated to the manufacture of active pharmaceutical ingredients (APIs), used for medicines for human diseases. We serve the pharma industry exclusively, and specialize in the development and synthesis of new APIs using state-of-the-art technology and quality.

Hovione was founded in Portugal in 1959 by Ivan Villax, and remains today an independently owned company. Hovione has 2 FDA inspected plants in Europe (Portugal) and the Far East (Macao) and a Technology Transfer Center in New Jersey, USA. With sales of USD146m, the company exports all of its production and technical services to a total of 28 countries worldwide.


What is Hovione´s activity?
The company manufactures generic drug active ingredients with processes developed in-house, and offers custom synthesis of APIs and regulated intermediates for oral, topical, inhalation and injectable grade products, including sterile bulk.

With respect to generics, Hovione has 4 main lines of products: semi-synthetic antibiotics, anti-inflammatory corticosteroids, and imaging agents used in injectable formulations for X-ray visualization of organs, arteries and veins, and anti-hyperlipidemics. In custom synthesis, Hovione develops and manufactures "new generation" APIs on an exclusive basis for its customers; these include anti-AIDS drugs, cancer therapies, Alzheimer´s treatments, and other novel therapies currently under investigation.

Hovione’s capabilities include process chemistry, worldwide regulatory affairs, and kilo to multi-ton manufacture of APIs under FDA to cGMP (current Good Manufacturing Practices) standards. Being one of the largest investor in the Portuguese pharmaceutical industry, Hovione has developed more than 100 chemical processes and holds more than 400 patents worldwide.

What does Hovione sell?
Hovione sells:

• Active Pharmaceutical Ingredients
• Technical services, namely:
• Development, optimization and industrialization of API chemical processes;
• Small quantity APIs for clinical trials;
• Process validation;
• Analytical methods development;
• Worldwide registration with health authorities.
• Particle Design
• Formulation Development

What are Hovione sales and main markets?
With worldwide yearly revenues of about US$146m, Hovione´s main markets are North America, Europe and Japan.
Hovione supplies its products and technical services to both large pharmaceutical multinationals, and to small or medium sized biotech or drug discovery companies.

Where is Hovione present internationally?
• Loures, Portugal – R&D center and manufacturing
• Macau, South China - Manufacturing plant
• New Jersey, USA - Technology Transfer Center
• Lucerne, Switzerland – Licensing Office
• Hong Kong – Sales Office

Why did Hovione build a plant in Macao?
For its proximity to the People´s Republic of China which supplies almost 80% of the raw materials that the company uses, allowing for a competitive cost advantage. Built in 1987, this plant manufactures a third of Hovione´s total production and exports to Japan, the European Union, USA, Asia, Australia and New Zealand.

What are Hovione´s main differentiating factors?
Hovione distinguishes itself by its technological capacity and expertise, as well as by its superior customer service. Hovione's main asset consists of its highly specialized know how and its dedication to R&D, in which it invests annually 8% of its revenues.

How many people does Hovione employ?
Hovione employs 1100 professionals worldwide, of which more than 360 have a university degree and 40 have PhDs. The average age is between 38 years. Hovione employs more professionals in R&D and quality than it does in production.


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FAQs - Technology Transfer Center (TTC)
East Windsor, New Jersey

When and why did Hovione establish a presence in the USA?
Hovione LLC was incorporated in the USA in April 2001, naming Dave Hoffman President of US Operations. Since the USA is Hovione´s biggest market, the company´s presence in New Jersey allows for a greater proximity to its US customers offering them a better and more efficient service and technical support. Hovione´s presence in the US consists of a Technology Transfer Centre (TTC) in East Windsor, New Jersey.

Where is the TTC located and why?
The TTC is located on an 8 acre parcel of land just off exit 8 of the New Jersey Turnpike, in East Windsor. East Windsor Township is an ideal location for technology companies servicing the Pharmaceutical Industry due to its proximity to 9 of the world´s major pharmaceutical companies. The township also has an excellent professional community owing to its centralized location between New York and Philadelphia.

When did the TTC started its operations?
Groundbreaking took place on October 8, 2001 and initial occupancy occurred in August 2002. CUH2A, Inc. (Princeton, NJ), a world leader in the design and engineering of laboratory facilities was appointed the architectural engineering firm, and Engineered Technologies Corporation, (Providence, RI) the equipment manufacturer for the TTC. Turner Construction Company of Somerset, NJ managed the construction of the facility.

What does the TTC consist of?
The new TTC building has a total area of 26,000 sq.ft. The site consists of commercial offices as well as development laboratories, a GMP pilot plant and a GMP Spray Dryer for small scale preparation of novel APIs.

What is the TTC´s offer?
The TTC offers process development and scale up services, along with quality control/assurance and regulatory support to the pharmaceutical industry. The TTC can undertake the initial process development of new APIs and produce small quantities for clinical trials as well as validate and produce small volume commercial drug substances. The technical capability of the TTC mimics that of Hovione’s fully commercial facilities located in Europe and South China for seamless transition of the process to commercial scale production. The TTC is fully integrated into Hovione’s global quality network offering US customer’s real-time data and regulatory support for on-going production in Europe and China.

How many people does the TTC employ?
The TTC employs a total of 49 people, including research, production and supporting services.

What authorities will govern the TTC´s activities?
The TTC's activity is in compliance with FDA Regulations and Good Manufacturing Practices, as well as ICH (International Committee for Harmonization) Guidelines. The TTC was last inspected by the FDA in April 2011.
In terms of Safety and Environment, Hovione is a subscriber to the International Chamber of Commerce Charter for Sustainable Development. The facility is an OSHA VPP STAR worksite. The facility is run in accordance with a Responsible Care Program, which includes having an open relationship with the community. This includes the neighborhood, the fire department, emergency medical personnel and the East Windsor Municipal Utility Authority.
The TTC follows Department of Transportations (DOT) regulations (49CFR) implementing the Hazmat Security plan. The site is also under the New Jersey Environmental Protection (NJDEP) regulations (40CFR) for air, water and waste. The site has been successful inspected on a periodic basis.

How does the TTC address environmental concerns?
It is Hovione´s policy to responsibly address environmental as well as safety issues in all areas - at the design project level of any construction, at the R&D level of the API process development, and in its procedures and professional attitude. Details of our Environment and Safety at Work policy specific to the New Jersey site have been drawn up. No complaints have been received from neighbors or Township officials concerning the operation of the facility.

How does the TTC address air quality - atmospheric emissions?
All the vent lines from the reactors in either the large scale-up laboratory or pilot plant area are treated by use of a three stage control system. Each reactor is equipped with a vent condenser operating at -37 F, which is intended to remove any solvent contaminants from the exhaust. The exhaust passes through a "scrubber" unit to further remove any remaining contaminants from the exhaust stream and then prior to being exhausted through the exhaust stack it is filtered through a carbon absorption filter, which eliminates any remaining air born contaminants. The facility is currently permitted and regularly monitored by the NJ Department of Environmental Protection (NJDEP) for all air emissions from the site. No visible emissions or odors have been detected or reported by neighbors or Township officials.

How does the TTC address water quality - residual waters?
All cooling water used within the facility is provided by internal closed loop cooling system and is not interconnected to the municipal city water lines.
All the firewater is collected in a firewater containment system. This is to prevent contamination of the municipal treatment facility as well as the surrounding grounds of the TTC. Firewater is collected in a holding tank and is then sampled to determine if it is within the Township discharge limits. Collected water within limits is discharged to the municipal authority. Water which is not within discharge limits is collected by a licensed waste contractor and sent to a permitted wastewater treatment facility.
Discharges of wastewater to the municipal authority are monitored periodically by the Township to ensure all contaminants are within discharge limits.

How does the TTC address Safety?
The site was approved for participation in the OSHA Voluntary Protection Program (VPP) on 1 June 2007. Participation in this prestigious program is limited to facilities which have accident and injury rates below their industry average for at least three years and have a safety & health program that exceeds the current regulatory standards. The TTC is free from regulatory inspections by OSHA for a period of at least 3 years.
All chemical storage areas within the facility have separate spill containment. All areas of the facility, which use larger than laboratory quantities of products, are equipped with a foam suppression system. This is a total deluge sprinkler system, which is specifically designed to extinguish chemical related fires.
As part of our Responsible Care Program, the TTC has on record a copy of the Material Safety Data Sheet for all the products used within the facility and has provided a copy to the local fire and emergency response agencies for their records.
The facility is on the leading edge of the determination of occupational exposure limit estimations for new chemical entities and active pharmaceutical ingredients (API). Estimations involve set formulas which utilize known toxicological data and safety factors for human to animal interpolations or differences in exposure route or bioavailability. If data does not exist then a default categorization of "hazardous" is applied. Based on the OEL estimate, the associated engineering controls and work practices are implemented to ensure employee protection. Periodic air monitoring is conducted to ensure employee exposures are below design levels.
Each project is thoroughly evaluated from an HSE perspective prior to being accepted into the facility. A review is completed on all solvents and raw materials to determine health or environmental risk. Very hazardous chemicals are handled similar to the hazardous API with all associated controls. Environmental impact is also assessed to include air or water permit limitations as well as waste generation. Any chemicals which may not be utilized at the facility within regulatory limits are required to have a less hazardous substitute.

How does the TTC handle residual wastes?
All hazardous and chemical wastes are collected and transferred from the TTC via a licensed waste contractor to a State Approved Treatment Facility. Any wastes which contain API's or intermediates are treated by incineration.
Waste batteries and fluorescent lights are collected and sent for offsite recycling by a licensed waste contractor. Cardboard, office paper, glass and aluminum are collected and recycled by the Township.
The facility has a current Waste Minimization Program to try and reduce the quantity and hazards of the wastes generated.



Updated: October 2011

For further information, please contact:

In the US:

Toll free: 866 918 2601
Hovione LLC
40 Lake Drive
East Windsor
NJ 08520

Tel: + 1 609 918 2600 - Fax: +1 609 918 2615
Email: