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Strategic Attachment & Training (STRAT) Programme in Biomedical Science |
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The Strategic Attachment and Training (STRAT) programme is an initiative by the
Economic Development Board (EDB) to build up key manpower capabilities in Singapore’s workforce for emerging sectors and activities, through overseas attachment and training with leading companies.
Lonza Biologics Tuas Pte Ltd, in conjunction with EDB is offering 40 training places
for aspiring graduates who are interested in the field of Biopharmaceuticals. Here you can find further information about Lonza and the specific areas. |
About Lonza Biologics
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Lonza Biologics uses mammalian cell culture for biopharmaceutical manufacturing and has four facilities around the world – Slough (UK), Porriño (Spain), Portsmouth (New Hampshire, USA) and now Tuas in Singapore. All these sites manufacture recombinant proteins and monoclonal antibodies on behalf of our clients in the pharmaceutical industry.
Lonza Biologics Tuas is located in Tuas Biomedical Park and is a joint venture between Lonza and Singapore’s EDB’s biomedical sciences investment management arm Bio*One Capital. Currently building the facility for around US$300 million, this biopharmaceutical production facility will be one of Singapore’s largest commercial large scale mammalian biologics manufacturing facilities and will become operational in 2011. The design of the facility is based primarily upon that already built in Portsmouth, New Hampshire (USA) but assignments to any of the three overseas facilities as part of the STRAT program will be directly relevant to roles in Singapore. |
Manufacturing at Lonza
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The Manufacturing Team at Lonza is responsible for making and purifying the proteins and antibodies that are needed to treat patients who suffer from ailments such as asthma or psoriasis to breast cancer or non Hodgkin’s Lymphoma.
As a contract manufacturer, Lonza sees many different products from many different customers. Our plant design is there for geared to handling a multitude of different process types.
As a GMP manufacturing facility making commercially available products, we expect the highest level of attention to detail, communication skills, and teamwork aptitude from our employees. Much time goes in to technical training and use of process and operational improvement strategies to keep us at the forefront of our industry.
Lean Manufacturing, Operational Excellence, 5 S, Kaizan, are just a few of the methods we employ to continuously improve our practices. |
The Process
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Our production process is split up into to two activities; Cell Culture Fermentation and Down Stream Purification. The first is where the product is made, the latter is where the product is put in a state that is a safe formulation for patient use.
In the Cell Culture area, the process begins in the Inoculum area. Mammalian cells, genetically engineered to produce a target protein, are removed from cryogenic storage and thawed. These single cells are cultured with the aim of increasing their density to a sufficient amount in order so that the culture can be progressively performed at larger scale. The production scale at Lonza is 20,000L.
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Our production process is split up into to two activities; Cell Culture Fermentation and Down Stream Purification. The first is where the product is made, the latter is where the product is put in a state that is a safe formulation for patient use.
In the Cell Culture area, the process begins in the Inoculum area. Mammalian cells, genetically engineered to produce a target protein, are removed from cryogenic storage and thawed. These single cells are cultured with the aim of increasing their density to a sufficient amount in order so that the culture can be progressively performed at larger scale. The production scale at Lonza is 20,000L.
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The People
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The Manufacturing team functions 24 hrs, 7 days a week. The process rarely stops so neither do we! There are shifts to support operations in all areas where processing runs outside of normal working hours. Each shift it manned by a Supervisor, Biotechnologists, and Production Technicians.
A shift’s responsibilities include the following operations.
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Cell Culture
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• Inoculum operations including open aseptic manipulations in Biosafety cabinets and operation of S20 and S50 Wave® Bioreactors
• Operations on stirred tank Bioreactors 200L to 20,000L – Media equilibration, cell culture inoculation, process monitoring, batch feeds and transfers
• Harvest operations including the use of a disc stack centrifuge and depth filtration
• In process sampling and monitoring – off line tests for cell density and viability, nutrient levels, pH and osmolality
• CIP skid and SIP sequence execution and monitoring using the Delta V© distributed control system
• Preparation of media and feeds
• Operating using SOP’s and documentation of actions in GMP batch records
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Down Stream Purification
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• Operations on chromatography columns 1.4M to 2.0M in diameter including packing and unpacking of resin
• Ultrafiltration/diafiltration and viral reduction systems (tangential flow filtration), 100m² membrane surface area
• Product sampling and in process testing for protein concentration, pH and conductivity levels
• CIP skid and SIP sequence execution and monitoring using the Delta V© distributed control system
• Preparation and storage of buffers used in the purification process
• Operating using SOP’s and documentation of actions in GMP batch records
Training is given to employees on an ongoing basis to enhance their technical expertise, operate safely and help to further understand the GMP guideline set be various regulatory agencies from around the world e.g. FDA, EMEA.
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Quality Assurance at Lonza |
| Ever had second thoughts when taking a painkiller to help relieve a headache, worried that it might be another medicine intended for some other ailment? Or wonder if an injection administered into your body is safe and will not cause you any harm? Hopefully not! How would you be able to tell the difference anyway? It’s not that you could tell it’s wrong or unsafe by its taste or look!
Most, if not all of us, take medicines based on trust. We trust the doctor prescribing it and ultimately the pharmaceutical companies which manufacture and supply it. Because medicines have such a huge impact on people’s health and safety, it is therefore not surprising to find this industry of manufacturing medicines being governed by special laws and codes of practice. More commonly referred to as Good Manufacturing Practice (GMP), these laws are a series of rules and guidelines which ensure all medicinal products are manufactured in a consistent and controlled manner to be safe and effective.
In the context of pharmaceutical manufacturing, QA functions as the company's internal quality, auditing and compliance group. Here at Lonza, we in QA pride ourselves in ensuring every important aspect that contributes to getting a medicinal product produced in our facility is working to GMP, so that every batch of product being released from our facility is safe and effective, and will not place any life of a patient taking our medication at risk.
So how does QA achieve this? We work closely with the various departments to develop, establish and maintain quality systems necessary to ensure compliance with the various GMP regulations and that they are effective. On an ongoing basis, the QA department provides regulatory oversight and advises the various departments on the GMP requirements which affect them. Audits are also performed from time to time to help ascertain that quality systems are functioning as they should.
QA professionals in these capacities will often have to exercise sound judgment to make decisions that will meet business needs and yet not compromise product safety. In these situations, we draw on our and others technical knowledge and experience, logical reasoning and our understanding of GMP to arrive at the decisions. To be effective in this, we engage our colleagues on activities on the field – be it with QC in the laboratory, Manufacturing in the production area, or Engineering in an area under validation – for us to be close to and understand the operations in order to make the most appropriate decisions. Therefore our job is certainly not boring but more often stimulating and challenging! A keen and logical mind and a propensity to tend to details are certainly attributes needed to be a good QA professional.
In the training of a STRAT to become a future QA professional, the individual will be involved in managing and executing quality systems like Document Management, Audits, Training, Deviations Management, Change Management, Validation and Lot Release. As part of the training, he/she will also be exposed to tools and computerised systems associated with these quality systems, like SAP, Trackwise and Documentum.
In an industry where quality is spoken of in terms of curing illnesses and ensuring safety to patients, and in Lonza where quality is at the heart of everything we do, the QA team is at the forefront steering the way. Come join us today and be part of our high performance team, where quality is indeed our business! |
Quality Control at Lonza |
| Quality Control has the primary function to ensure that a quality product is produced within a controlled environment. To achieve this goal, Lonza QC performs a wide variety of tests to evaluate both the product, and the manufacturing facility’s environment. Lonza is engaged in different testing methodologies, ranging from microbiology and molecular biology to the latest analytical chemistry techniques. As a STRAT, you will be exposed to the areas below (EM, Micro, Analytical/Biochem), in which responsibilities span across several QC activities.
Typical Lonza QC activities include the following:
• Bulk Drug Substance
• In-Process Fermentation and Purification Testing
• Raw Material sampling, testing, and raw material qualification
• Environmental Monitoring of Water, Gas, Air and Surfaces samples
• Validation testing to support equipment/system validation and Process Validation
• Stability Program |
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Lonza Environmental Monitoring is used to test facility water, steam, gas, and environmental air and surface samples are collected and tested to ensure the facility’s environment is maintained in a controlled state. Lonza EM personnel are both exposed to the facility as a whole, as well as EM sampling and testing techniques. Data Analysis is performed on EM data to show environmental trends that occur over time. Investigations are conducted for all facility excursions or failing samples.
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Microbiology is used to ensure there is no bacterial or fungal contamination in the facility or products produced. When microbial contamination is discovered, the identification of the contaminant is found using genetic analysis, ensuring the most accurate results. Lonza QC staff utilizes both instrumentation as well as classical microbiology techniques to test samples.
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| At Lonza, a variety of analytical chemistry (UV, HPLC, CE), molecular biology (PCR), and immunology (ELISA, Potency) tests are employed to test the product’s attributes: Safety, Integrity, Strength, Purity, and Quality. QC staff is heavily involved in supporting manufacturing and the process by using tests that are taken in-process as well as the final bulk drug substance samples. These same tests are then used to determine a product’s stability or shelf-life in the market. Lonza QC staff periodically undergoes various trainings to enhance one’s skill set within the department or overall skill in performing a job in the biotech/pharmaceutical industry. |
Manufacturing Sciences and Technology (MSAT) group at Lonza
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As one of the world’s foremost contract manufacturing companies, Lonza Biologics produces a large number of different biopharmaceutical products for customers ranging from small biotech companies to large multinational pharmaceutical corporations. Every time a new product manufacturing process is introduced into the Lonza Singapore plant, members of the MSAT group play a key role in ensuring that this is done correctly. They work closely with the Customer’s process development and technical experts to thoroughly understand the process, write detailed instruction sheets (called Batch Records) that Manufacturing staff use to run the process in the plant, monitor how the process is being performed on the manufacturing floor, and help resolve technical issues that may arise during the production. They also provide technical input into the preparation of regulatory submissions and answer process related questions during customer/regulatory agency audits/inspections. The MSAT group also runs a state-of-the-art process laboratory, consisting of small-scale bioreactors, purification systems and analytical equipment, where the production process is reproduced at a small scale. Experiments are performed in this lab to demonstrate successful process transfer and resolve any technical process issues as they arise. They are also in touch with Process Development and MSAT groups at other Lonza sites (USA, UK, and Spain) as well as with the greater biotechnology scientific community to keep abreast of the latest advances in process technology.
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Members of the MSAT group need to have a strong scientific and/or engineering background and specialize in either the cell culture area or the downstream purification area. They need to have good interpersonal and communication skills since they work closely with Manufacturing, Quality Assurance, Quality Control, and Engineering groups to implement the process and resolve issues. They also need to have good technical writing and data analysis skills.
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As a trainee in the MSAT group, you will train with scientists and engineers in MSAT groups at other Lonza sites to hone the skills described above. You will develop your knowledge of the technology behind the biotech industry and will play a central role in ensuring that Lonza Biologics meets its business commitment and keeps its customers satisfied.
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