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May 19, 2023 (posted viaProZ.com): Just completed a IPO-related translation+editing job, Chinese to English, 28,000 words, for a China company to be listed on HK stock exchange...more »
Editing/proofreading 作業量: 10000 words 記入日： Nov 2006 Languages: 英語 から 中国語
10,000 words proofreading of medical documents
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Translation 作業量: 3344 words 記入日： May 2006 Languages: 日本語 から 英語
10 pages translation of journal articles
Hi, Jianli Hou,
you (and your team?) did a really great job of the translation.
I personally am very, very pleased with your result.
After editing, a few minor corrections were made, but nothing
of concern.
Yes, you will receive a bonus payment (to be announced) for
completing a difficult assignment well and on time.
Word count is 3344, so please use this count for your invoice.
Best, for now
化学、化学工学
好意的 Blue Board outsourcer (20 to 50 entries): Excellent, prompt, reliable, accurate
Translation 作業量: 879 words 記入日： May 2006 Languages: 中国語 から 英語
2 pages translation of mathematics abstract
数学&統計学
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Translation 作業量: 200 words 記入日： May 2006 Languages: 中国語 から 英語
short medical translation
医療(一般), 医療: 製薬
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Translation 作業量: 1310 words 記入日： May 2006 Languages: 英語 から 中国語
7 pages of business translation
建設/土木工学, 保険, 不動産
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Translation 作業量: 6046 words 記入日： May 2006 Languages: 日本語 から 英語
Business translation
ビジネス/商業(一般), 人事, 経営
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Translation 作業量: 1500 words 記入日： May 2006 Languages: 英語 から 中国語
Chinese yuan (cny), Euro (eur), Pounds sterling (gbp), Hong Kong dollars (hkd), U. S. dollars (usd)
ポートフォリオ
翻訳サンプル提出済み: 4
英語 から 中国語: Nexium becomes no. 1 best-selling PPI worldwidea
原書のテキスト - 英語 Nexium has achieved world number one status in the Proton Pump Inhibitor market* - a remarkable success story in just five years since launch. But the story has just begun. Here we look at the advantages and future opportunities for Nexium.
Just a month ago, CEO Sir Tom McKillop commented: "The whole pharmaceutical industry is full of admiration for what has been achieved with Nexium. Many CEOs tell me what a fantastic job XXX has done with the product, and indeed how we have set the benchmark in developing a therapeutic area with Nexium."
CEO designate Dave Brennan added:"You take a look at what we've accomplished with this product, and I think it silences a lot of the critics. We¡¯ve been able to do it because it is a better product, and we¡¯ve been able to demonstrate that to patients and to customers in marketplaces around the world."
With 26.6 percent of the PPI market value worldwide, Nexium beat the closest competitor lansoprazole for the first time in October *, despite being launched in fewer markets. Eight years ago, XXX ¡¯s best-known product ¨C Losec ¨C was the biggest-selling prescription drug in the world. The company was very much a pioneer in the GI field and Losec was a first-in-class drug, the first proton pump inhibitor (PPI) for treating acid-related diseases. But despite its success, there were still unmet patient needs ¨C and there were still symptom breakthroughs." So the company was very much committed to finding a better product and we explored hundreds of different compounds to find an alternative," said Nexium VP Peter Wallich.
"In the end ¨C and completely unexpectedly ¨C we found that one of the isomers of Losec showed completely different characteristics to the other, demonstrating increased bioavailability, decreased inter-individual variability and better acid control, and a greater potential than Losec for patient benefits."
"We concentrated on areas of greatest need and there was a huge marketing effort with a very consistent brand position ¨C demonstrating better efficacy for many patients and meeting patient needs. A range of studies against our competitors ¨C and against Losec ¨C established that Nexium was the most effective PPI in the world, offering distinct clinical improvements for many patients over all other PPIs on the market," said Peter. "We had been looking for a drug that was better than Losec ¨C and we found it in Nexium. Nexium is now regarded as the gold standard in PPI therapy."
Said Sir Tom: "This isn't some kind of mirage, or a bit of mythology, or marketing skill alone. Success begins with the product. It begins with the quality of the clinical studies that we've conducted; the strength of evidence, and then followed, of course, by the professionalism of the sales and marketing. Becoming number one is a huge achievement and a tribute to everyone in the company who has been associated with the product. This is a $4.5billion a year product within five years of launch ¨C the most successfully launched product ever in the history of the industry ¨C still growing at 20% a year ¨C fantastic!"
Dave Brennan said: "It is important to remember how much of a difference this product makes for patients. It makes a difference to people¡¯s lives and allows them to return to doing things that they might not have been able to do in their lives for a long time."
Nexium was first launched in Sweden in August 2000 and is now available in over 100 markets. Gaining approval for its use in the healing and prevention of ulcers associated with NSAID (non-steroidal anti-inflammatory drug) therapy was particularly significant at a time when some COX-2 painkillers ¨C with their promise of reducing GI ulcers ¨C were questioned by regulatory authorities because of CV side-effects. ¡°It put Nexium in a good position,¡± said Peter. Many patients treated with COX-2s or NSAIDs have GI symptoms and risk of ulcer due to these medicines and consequently are prescribed Nexium.
The biggest success for Nexium has been its effectiveness in treating GERD ¨C gastroesophageal reflux disease. Some 20% of adults in the western world suffer from GERD and its associated heartburn pain.
For the future, to build on its current status as world number one PPI, the company is concentrating on developing the market for GERD treatment ¨C and investigating Nexium¡¯s use in other related areas.
"If you look at what we've accomplished with Nexium in the first five years, it really gives us an ambitious target for the future of this product. Getting to be number one is a tremendous accomplishment, and we now need to distance ourselves from number two. We want to be number one by a long shot and I think the sky¡¯s the limit. This is still a big market; there are still opportunities for us to grow within the market, and what we need to do is think about broadening our leadership position so that we can truly realise the full potential of this product in the marketplace." Said Dave Brennan.
翻訳 - 中国語 耐信成为全球最畅销的质子泵抑制剂
耐信已在质子泵抑制剂 (PPI) 市场上获得了全球第一的地位*，这是耐信自投放市场以来整整五年内一个极为成功的创举。 但是这只是一个开头，接下来让我们来看看耐信的优势和发展前景如何。
一个月前，XXX 公司首席执行官麦奇洛爵士 (Tom McKillop) 发表评论指出：“整个制药行业都对耐信所取得的成功羡慕不已， 许多CEO告诉我说XXX 在耐信方面所做的工作简直是太神奇了。的确，我们在开发耐信的治疗领域方面已建立了一个具有重要意义的里程碑。”
XXX 现任首席执行官 Dave Brennan 补充道：“大家都可以看到我们在这一产品上所取得的成功，我想它足以使许多批评销声匿迹。 我们之所以能取得这么好的成绩，是因为耐信是一款非常出色的产品，我们也已经向全球市场上的患者和客户证明了这一点。”
虽然耐信投放的市场不多，但是它却拥有26.6 %的全球 PPI 市场份额，并在十月份首次击败了最具竞争力的药物兰索拉唑 (lansoprazole)*。 八年前，XXX 最有名的产品――洛赛克是全球最畅销的处方药。 当时的阿斯利康公司在胃肠道治疗领域一直处于领先地位，洛赛克是一种极好的药物，是治疗酸性相关疾病的首选质子泵抑制剂（PPI）。 洛赛克虽然有其成功之处，但我们仍然未能满足某些患者的需求，而且仍然需要在改善患者的症状方面有所突破。耐信副总裁 Peter Wallich 表示：“所以我们一直致力于开发一种更好的产品，并通过研究上千种不同的化合物来寻求洛赛克的替代产品。”。
“完全出乎意料的是：最后我们在洛赛克的众多同分异构体中发现了一个特性与其它完全不同的药物。在患者受益方面与洛赛克相比，这种药物具有更高的生物利用度、更低的个体间变异度、更好的酸性控制能力和更高的潜力。”
Peter 补充道：“我们把重点放在需求最大的领域。虽然在一个巨大的市场上维持一个品牌的长久地位需要付出艰辛的努力，但我们所做的一切证明：对于许多患者来说，这种药物具有更好的疗效并能满足他们的需求。“针对我们的竞争对手和洛赛克所做的一系列研究表明：耐信是世界上最有效的质子泵抑制剂，与市场上的所有其它质子泵抑制剂相比，它能为许多患者带来特别明显的临床改善。我们一直在寻找一种比洛赛克更好的药物，现在我们终于有所发现，它就是耐信。目前，耐信被认为是质子泵抑制剂治疗的黄金标准。”
麦奇络爵士指出：“耐信的成功不是什么海市蜃楼，不是什么传奇神话，也不是单纯的市场技巧。 它的成功源自于产品本身， 源自于我们所进行临床研究的质量和证据的有力性，当然接下来就是销售和市场上的专业性。 成为世界第一是一项巨大的成就，而且对与该产品有关的公司里的每个人来说也是一种奖励。 该产品在投放市场的短短五年里就达到了每年 45 亿美元的销售业绩，成为了业界历史上最成功的产品。同时它仍然以每年 20% 的速度增长，简直是太不可思议了！”
Dave Brennan 指出：“需要重点指出的是，该产品为患者带来了极大的变化。 它使人们的生活产生了变化，使他们能够重新做以前在生活中很长时间都不能做的事情。”
耐信在 2000 年 7 月首次在瑞典投放市场，现在已在100多个市场上销售。 当一些声称可以减少胃肠道溃疡的 COX-2（环氧化酶 2）止痛药因为心血管 (CV) 副作用而受到监管部门的质疑时，耐信在治疗和预防NSAID（非甾体抗炎药）治疗所引起的溃疡方面的使用而得到了认可，因而立刻成为了人们关注的焦点。 Peter 接着说道：“这使得耐信处于一种十分有利的地位”。 许多使用 COX-2 或 NSAID 的患者都有胃肠道症状以及因使用这些药物而引起溃疡的危险性，因此人们都开始使用耐信。
耐信最大的成功是在治疗GERD――胃食管返流疾病方面特别有效，而西方国家有20%的成年人都患有胃食管返流疾病以及与之相关的胃灼热痛。
对于将来，为了巩固目前耐信作为世界一号 PPI 的地位，XXX 公司正集中于开发 GERD 治疗市场，并在调查耐信在其它相关领域的应用。
Dave Brennan 补充道：“如果你看到我们在过去五年所取得的成就，你肯定会对耐信的前景充满希望，同时它也确实给我们带来了极大的信心。 成为世界第一是一项巨大的成就，我们现在需要努力去永远保持第一。 我们希望能在长时间内保持这个第一，“海阔凭鱼跃，天高任鸟飞”，我想我们必定会大有作为。 这是一个巨大的市场，在这个市场里我们仍然有很多机会去发展，我们需要做的是思考如何扩大我们的领导地位，这样我们才能真正挖掘出该产品在市场上的所有潜力。”
英語 から 中国語: MassTrak™ Systems
原書のテキスト - 英語 XXX Corporation, incorporating XXX Technologies, has over 40 years history of developing innovative HPLC, mass spectrometry, software, chemistry and support services. XXX can now provide clinical research laboratories with complete solutions that can improve the accuracy and precision of your assays, and increase productivity.
MassTrak™ Systems bring the power of tandem mass spectrometry in a robust, easy-to-use, cost-effective package. These systems bring new levels of sample throughput, sensitivity, specificity and flexibility for therapeutic drug monitoring, toxicology and many other applications.
For clinical research laboratories, MassTrak™ Systems provide:
• Fast Speed of Analysis
Enable high sample throughput and rapid turnaround of time-sensitive samples
• Improved Specificity
Eliminate cross-reactivity problems associated with immunoassays, providing excellent accuracy and precision for therapeutic drug monitoring and clinical biomarker analysis
• Increased Sensitivity
Give reliable results at low ng/mL levels, especially important for emerging drug therapies
• Enhanced Flexibility
Provide the capability to analyze a wide range of compounds on the same system
• Robust Tandem MS Methods
Ensure the quality and reliability of analysis
MassTrak™ Systems for LC/MS/MS Set New
Standards for Clinical Research Applications
Many of the assays performed in research laboratories involve the identification and quantification of chemical species in complex biological matrices. Today¡¯s clinical chemists demand more accurate and cost-effective analytical tools that can be easily integrated into current laboratory practices.
LC/MS/MS is ideally suited to many clinical research applications as the selectivity of the technique enables individual analytes to be quantified confidently. MassTrak™ Systems integrate HPLC, chemistries, mass spectrometry, software and support services for clinical research facilities worldwide. Single vendor support is also available through XXX dedicated clinical team.
LC/MS/MS Applications
MassTrak™ Systems are offered for therapeutic drug monitoring and drugs of abuse analysis including both confirmation and systematic toxicological analysis. These systems include a HPLC, a mass spectrometer and a data application manager, and are routinely used in clinical research laboratories worldwide for the following applications:
Therapeutic Drug Monitoring
• Cyclosporin A
• Tacrolimus
• Sirolimus
• Everolimus
• Mycophenolic Acid
• Tobramycin
Inborn Errors of Metabolism
• Amino Acid Disorders
• Fatty Acid Oxidation Defects
• Organic Acidemias
Clinical Biomarkers
• Homocysteine
• Methylmalonic Acid
• Vitamin D
• Steroid analysis
• Catecholamines and Metanephrines
Clinical and Forensic Toxicology
• Amphetamines
• Opiates
• GHB
• Cannabis and Metabolites
• Cocaine
• Benzodiazepines
XXX MassTrak™ Systems
Applications Inlet Instrumentation MS Instrumentation Applications Managers
Therapeutic Drug Monitoring Alliance® HT 2795 Quattro micro™ QuanLynx™
Drugs of Abuse: Confirmation/Quantification Alliance® HT 2795 Quattro micro™ TargetLynx™
Drugs of Abuse: Systematic Toxicological Analysis Alliance® 2695 ZQ™ ChromaLynx™
翻訳 - 英語 ¢ñ. Overview of Production Methods of Rabies Vaccine for Human Use
This product is prepared for the use of rabies prevention by means of vaccinating the primary hamster kidney cell (PHKC) against the fixed strain of rabies virus, collecting the virus liquid after cell culture, diluting it with PBS (phosphate buffered saline) after inactivation, concentration and purification of virus and adding the human serum albumin.
1. Basic requirements
The facilities, raw & ancillary materials, water, appliances and animals etc used for production, examination and determination should comply with the requirements of Tripartite ¡°General Notes¡± of the 2005 Edition Pharmacopoeia of the People's Republic of China (abbreviated as the Chinese Pharmacopoeia 2005, Ch.P.2005).
2. Production
2.1 Cells used for production
The cells used for production are primary hamster kidney cells or hamster kidney cells with no more than five serial passages.
2.1.1 Cell management and assay
It should comply with relevant regulations of the Specifications for Preparation and Assay of Animal Cell Matrixes Used for the Manufacturing of Biological Products of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China.
2.1.2 Cell preparation
Select the healthy hamsters with 12~14 days of age to take kidneys from them with aseptic manipulation, shear the kidneys into pieces, disperse the cells after trypsinization and add 8%~10% inactivated calf serum with Earle's Balanced Salt Solution (EBSS) containing 0.4% lactoalbumin hydrolysate into the inoculated culture bottle. The stock solutions prepared with same production cycle, same batch of raw materials and same method are made as a batch.
2.2 Virus seed
2.2.1 Name and source
The virus seed used for production is the fixed strain (aG) of rabies virus.
2.2.2 Establishment of seed lot
It should comply with relevant regulations of the Specifications for Management of Bacterial Spawns and Viruses Used for the Manufacturing and Assay of Biological Products of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China.
The original seed lots are purchased from the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) with the generation number of 4aG2. The generation number of master seed lot is 4aG3 and that of working seed lot is 4aG4.
2.2.3 Assay of seed lot
The master seed lot should be given the following full assay and the working seed lot should be given the assay of 2.2.3.1~2.2.3.5 items at least.
2.2.3.1 Identification test
The specificity of virus seed should be identified with the intracerebral neutralization test of mice and the neutralization index should be no less than 500.
2.2.3.2 Titration of virus
The virus seed is given 10 times of serial dilution and the mice weighing 11~13g with intracerebral inoculation should be no less than 6 at each dilution. The virus titer should be 8.0 ~9.5LgLD50/ml.
2.2.3.3 Sterility test
It should be examined in compliance with relevant laws and regulations (Appendix ¢üA of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
2.2.3.4 Mycoplasma test
It should be examined in compliance with relevant laws and regulations (Appendix ¢üB of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
2.2.3.5 Test of exogenous factors of virus
It should be examined in compliance with relevant laws and regulations (Appendix ¢üC of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
2.2.3.6 Immunogenicity test
The virus seed of master seed lot is inactivated directly and made into original vaccine which is injected in the abdominal cavity of mice weighing 12~14g, 0.5ml for each. Each mouse is given a second inoculation after 1 week. In the 14th day after the first immunization, the mice are given the intracerebral attack with the CVS virus in the form of 10 times of serial dilution (10-5, 10-6, 10-7and 10-8), 0.3ml for each mouse and ten mice at each dilution. Meanwhile the non-immune mice with same weight, as a control, are given the intracerebral attack with the CVS virus in the form of 10 times of serial dilution (10-2, 10-3, 10-4and 10-5), 0.3ml for each mouse and ten mice at each dilution. The protection index should be no less than 200.
2.2.4 Storage of virus seed
The freeze-dried virus seed should be stored at the temperature of less than -20¡æ, and the virus seed of liquid working seed lot should stored in the temperature of less than -60¡æ for no more than 2 years.
2.3 Preparation of stock solution
2.3.1 Cell preparation
It should be carried out according to Item 2.1.2.
2.3.2 Culture solution
The Earle's Balanced Salt Solution (EBSS) containing 0.4% lactoalbumin hydrolysate is added into the 8%~10% inactivated calf serum and the PH value is adjusted to 7.0~7.2 to carry out the cell culture. The quality standard of calf serum should comply with the regulations of tripartite structure (Appendix ¢ú¢óD) of the 2005 Edition Pharmacopoeia of the People's Republic of China.
2.3.3 Test of exogenous factors of control cell
It should be examined in compliance with relevant laws and regulations (Appendix ¢üC of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
2.3.4 Inoculation and culture of virus
Mix the supernatant liquid and cell suspension of rabies virus seed in the cell culture bottle. Carry out the cell culture of rabies virus seed with the inoculum size of 0.01¡«0.1MOI (or 4.5¡«5.5 LgLD50/ml) for 68~76 hours at the temperature of 36.5¡æ¡À1¡æ to make the cultured cell form dense monolayer, then remove the culture solution and use the physiological saline to wash it to remove calf serum, add the ¡°199¡± main medium containing human serum albumin in it and continue to place it at the temperature of 34¡æ¡À1¡æ to carry out the cell culture for 6~7 days.
2.3.5 Virus harvest
The virus liquid should be harvested after the completion of culture.
2.3.6 Assay of single harvest fluid of virus
It should be carried out according to Item 3.1.
2.3.7 Inactivation of virus
Add the 1/5000 formaldehyde solution in the harvest liquid of virus, inactive it in the conditions of 26¡æ¡À1¡æ for 96¡À1 hours and shake it twice every day, thus it¡¯ll be inactivated virus liquid.
2.3.8 Verification test of virus inactivation
According to Item 3.1.4, the virus should be taken a sample immediately after inactivation to perform the verification test of virus inactivation.
2.3.9 Concentration and purification of inactivated virus liquid
2.3.9.1 Combination, ultra-filtration and concentration
The harvest liquid of virus produced in the same batch is concentrated by 60¡À10 times through the ultra-filtration of ultra-filtration membrane with the molecular of 300KD, and is taken a sample to measure the protein content which should be 25mg/ ml- 40mg/ ml. The removal rate of hybridprotein after concentration should be no less than 82%.
2.3.9.2 Purification
Carry out the purification for the concentrated virus liquid with the method of Sepharose 4FF gel column chromatography after the assay is approved. Notice that the quantity of sample should be 5~10% of the gel volume in column every time. Elute it with the PBS with the PH value of 7.6 and the concentration of 0.01M, perform the monitoring with the ultraviolet rays of OD280, collect the first peak and take a sample from it to measure the protein content which should be 150¦Ìg/ ml-300¦Ìg/ ml. The removal rate of hybridprotein after purification should be no less than 99%. Add the human serum albumin into it as stabilizing agent after purification and add the thimerosal into it as antiseptic at the same time, thus it¡¯ll be the stock solution of vaccine. The content of human serum albumin is 0.4% and the thimerosal content is 0.0025% in the purified stock solution.
2.4 Assay of stock solution
It should be carried out according to Item 3.2.
2.5 Preparation of semi-finished products
2.5.1 Preparation
According to the measured protein content and antigenic content, the semi-finished products are prepared by adopting the protein content in semi-finished products as 60¦Ìg/dose. The stock solution will be made into semi-finished product after added with human serum albumin and thimerosal again. The content of human serum albumin is 2% and the thimerosal content is 0.003% in the semi-finished product.
2.5.2 Assay of semi-finished products
It should be carried out according to Item 3.3.
2.6 Preparation of finished products
2.6.1 Batch separation
It should comply with relevant regulations of the Specifications for Batch Separation of Biological Products of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China.
2.6.2 Sub-package
It should comply with relevant regulations of the Specifications for Sub-package and Freeze-drying of Biological Products of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China.
2.6.3 Specifications
1.0ml each bottle and 1.0ml of dose for human use each time. The titer of rabies vaccine should be no less than 2.5IU.
2.6.4 Package
It should comply with relevant regulations of the Specifications for Package of Biological Products of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China.
3. Assay
3.1 Assay of single harvest liquid of virus
3.1.1 Titration of virus
It should be carried out according to Item 2.2.3.2 and the titer should be 6.0 ~8.0LgLD50/ml.
3.1.2 Sterility test
It should be examined in compliance with relevant laws and regulations (Appendix ¢üA of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.1.3 Mycoplasma test
It should be examined in compliance with relevant laws and regulations (Appendix ¢üB of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.1.4 Verification test of inactivation
Use animal methods to carry out the intracerebral inoculation in 20 mice weighing 11~13g with inactivated stock solution, 0.03ml for each mouse. All the mice should still exist after 14 days of observation (not include the mice died within 3 days).
3.2 Assay of stock solution
3.2.1 Sterility test
It should be examined in compliance with relevant laws and regulations (Appendix ¢üA of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.2.2 Measurement of protein content
Select the stock solution that is not added with human serum albumin after purification and carry out the measurement according to relevant laws and regulations. The protein content should be 50~82¦Ìg/dose, see tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China (Clause 2 of Appendix ¢öB).
3.2.3 Antigenic content
Select the stock solution that is not added with human serum albumin after purification and measure the antigenic content with the method of euzymelinked immunosorbent assay. The antigenic content should be no less than 10IU/ml.
3.2.4 Residual volume of bovine serum albumin
The residual volume of bovine serum albumin is measured with the method of euzymelinked immunosorbent assay, and it should be no more than 50ng/dose.
3.3 Assay of semi-finished products
Sterility test
It should be examined in compliance with relevant laws and regulations (Appendix ¢üA of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.4 Assay of finished products
3.4.1 Identification test
According to Item 3.4.4, it should be carried out in compliance with relevant regulations. The identification test will be untenable if the titer measurement is not qualified.
3.4.2 Appearance
Colorless and transparent liquid
3.4.3 Chemical assay
3.4.3.1 PH value
It should be 7.2~8.0 (Appendix ¢õA of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.4.3.2 Thiomersal content
It should be 0.01 ~0.06mg/ml (Appendix ¢÷B of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.4.3.3 Content of free formaldehyde
It should be no more than 0.05mg/ml (Appendix ¢öL of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.4.4 Titer measurement
According to released standards, the titer should be no less than 4.0IU/dose and the titer within validity period should be no less than 2.5IU/dose. Two groups of animals will be measured for the titer test and the calculated mean is made as its result (Appendix ¢ûA of tripartite structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.4.5 Thermal stability test
The product should be given the thermal stability test before delivery. It should be carried out the titer measurement according to Item 3.4.4 after being placed at the temperature of 37¡æ for two weeks, and its titer should be no less than 2.5IU/dose.
3.4.6 Sterility test
It should be examined in compliance with relevant laws and regulations (Appendix ¢üA of Tripartite Structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.4.7 Examination of abnormal toxicity
It should be examined in compliance with relevant laws and regulations (Appendix ¢üF of Tripartite Structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
3.4.8 Examination of bacterial endotoxin
The bacterial endotoxin should be no more than 100EU/dose (Gel Limit Test in the Appendix ¢üE of Tripartite Structure of the 2005 Edition Pharmacopoeia of the People's Republic of China).
4. Storage, transportation and validity duration
It should be stored and transported away from light at the temperature of 2~8¡æ. The validity duration is 12 months since the date that the titer measurement is qualified.
¢ò. There are totally 10 persons who are directly responsible for the technology and monitoring of drug production in our company, and their names are listed as the following:
No.
Name
Seniority
Position
Title
Yang Guanglin
Si Chuang University, University graduate in Biology.
14 years¡¯ experience in relevant work.
Chief Product Officer
Yu Shuping
Party School of the CPC Central
Committee, junior college graduate in Biological Products.38 years¡¯ experience in relevant work.
Department of Production Management
Manager
Li Peng
Munitions University of the PLA, junior college graduate in Biological Products. 16 years¡¯ experience in relevant work.
Vaccine workshop
Director
Wang Huijuan
Baoding Urban Health School, specialized secondary school graduate in Medical Assisstant.10 years¡¯ experience in relevant work.
Vaccine workshop
Team leader of liquor distribution group
Guo Shuhui
Hebei University of Economics and Trade, junior college graduate in Marketing & Sales. 8 years¡¯ experience in this field.
Vaccine workshop
Team leader of cell group
Wang Xiaolong
Baoding Urban School of Economic Management, specialized secondary school graduate in Mechanical and Electrical Engineering. 7 years¡¯ experience in this field.
Vaccine workshop
Assisstant team leader of concentration group
Ji Guanghui
Hebei University, junior college graduate in Biology.10 years¡¯ experience in relevant work.
Sub-package workshop
Director
Wang Zhengjiang
Regional Health School of Baoding City, specialized secondary school graduate in Medical Assistant. 8 years¡¯ experience in relevant work.
Sub-package workshop
Team leader of sub-package group
Wang Pengfei
Hebei Engineering Vocational College, junior college graduate in Finance & Economics. 5 years¡¯ experience in this field.
Sub-package workshop
Team leader of package group
Zhu Gena
Baoding Urban Qiushi Medical College, specialized secondary school graduate in Medical Assistant. 8 years¡¯ experience in relevant work.
Sub-package workshop
Team leader of product inspection group
¢ó. Instruments and Equipments
No.
Instruments and equipments used during the course of pharmaceutical production
Complains about GMP
Water purifier
Yes
No¡Ì
Multi-effect water distiller
Yes
No¡Ì
Pure steam generator
Ultraviolet sterilizer
Plate heat exchanger
Delivery window
Power-driven pulsing vacuum sterilizer
Electrothermal automatic sterilizing oven
Liquid mixing tanker
Waste liquid tank
Vaccum pump
Air compressor
Adsorption-type drying tower
Refrigerant type dryer
Superclean bench
Mobile 100-grade laminar flow device
Bottle washer
Scouring table
Blender
Cell culture table
Collumn type filter
Ultra-filtration system
Collumn type chromatographic system
Peristaltic pump
Centrifuge
Water-bath inactivation box
Oilless mobile air compressor
Intergrity detection apparatus
Electronic balance
Acidometer
Ultrasonic bottle washer
Sterilizing drier
Filling machine
Magnetic stirring apparatus
Capper
Light-examination table
Pressure-sensitive labeling machine
Code-printing Machine
Bag closing machine
Automatic hand blower
Non-touching induction hand sterilizer
Cold storage system
Thermostatic chamber system
¢ô. Production capacity of manufactory at each work shift:
¢Å Because the production cycle of semi-finished product is relatively long, it has no way to calculate the output at each work shift. If the output is calculated in terms of feeding quantity, 28000~30000 units per person can be produced at each batch.
(2) For sub-package and package, 18000~20000 units per person can be produced at each work shift.
¢õ. The persons responsible for quality control are listed as the following:
No.
Name
Seniority
Position
Title
Zhang Lingmin
Hebei University, university graduate in Microbiology. 16 years¡¯ experience in relevant work.
QA
Manager
Yu Hongyan
Hebei University of Science & Technology, university graduate in Fine Chemical Industry. 4 years¡¯ experience in relevant work.
QC Supervisor
Zhao Yixin
Hebei University of Science & Technology, junior college graduate in Microbiology & Pharmaceutical. 8 years¡¯ experience in relevant work.
Team leader of physics & chemistry group
Li Xiuyun
Chang¡¯an Medical College of Shi Jiazhuang City, junior college graduate in Medical Laboratory Science.10 years¡¯ experience in relevant work.
Team leader of animal experiment group
Qu Libin
Hebei University, university graduate in Biology. 1 year¡¯s experience in relevant work.
Wang Yongquan
China Medical University, junior college graduate in Experimental Zoology. 1 year¡¯s experience in relevant work.
Liu Hongwei
Langfang Urban Health School, specialized secondary school graduate in Community Medicine.2 years¡¯ experience in relevant work.
Lu Kailang
Hubei Junior College of Pharmaceutical Inspection, junior college graduate in Pharmaceutical Preparation. 5 years¡¯ experience in relevant work
QA Supervisor
Yang Guosong
Hebei University, university graduate in Biotechnology.2 years¡¯ experience in relevant work.
Huang Ling
Hebei Vocation-technical Teachers College, university graduate in Biotechnology. 1 year¡¯s experience in relevant work.
Sun Xuenan
Xibei University, junior college graduate in Microbiology. 5 years¡¯ experience in relevant work.
Zhu Lining
Hebei University of Science & Technology, university graduate in Bioengineering. 2 years¡¯ experience in relevant work.
¢ö. Equipments used in the quality control on activated raw materials and final productsNo.
Names of Equiments
Biochemical incubator
Electrothermal water-insulation incubator
CO2 incubator
Centrifuge
Electrothermal thermostatic waterbath box
Electrothermal thermostatic waterbath pan
Minitype shaker
Digital acidometer
Digital electric conductivity analyzer
Visible spectrophotometer
Dust particle counter
Ultraviolet-visible spectrophotometer
Intergrity detection apparatus
Electrothermal air-blasting drying cabinet
Circulating-water vacumm pump
Refrigerator
Liquid nitrogen container
Clean bench
Desktop sterilizer
Primary reverse osmosis (RO) equipment
Electrical distillating apparatus
¢÷. Instructions of water treatment equipments
The water treatment part is mainly consisted of purified water system and water-for-injection system. According to the requirements of production, each workshop is equipped with separate water treatment equipments.
1. Purified water system
According to the demand of production workshop for purified water, the water purifiers with the following specifications are used in main production workshops of our company, as is listed in the following table:
Workshop nmae
Type of water purifier
Water output
Structure
Functions
Vaccine workshop
4t/h Secondary reverse osmosis+EDI
Provide ingredient water for multi-effect water distiller and provide water for washing and swilling
Sub-package workshop
2t/h Secondary reverse osmosis
Provide ingredient water for multi-effect water distiller and provide water for washing and swilling
Experimental animal room
0.5t/h Secondary reverse osmosis
Provide water for washing and swilling, and provide drinking water for experimental animals
QA Department
100l/h Primary reverse osmosis
Provide water for washing and swilling in the laboratory
The water purifier is designed and manufactured based on the most advanced and matured separation process of reverse osmosis membrane in today¡¯s world in combination with the latest electro-deionization (EDI) desalination technology. The new water purification technology not only can produce high-quality purified water, but also can reduce operation cost. With the adoption of advanced automatic control technologies, this system further simplifies the operation of water treatment system and makes its running more stable, and there is no discharge of chemical wastewater during the course of running of the equipment, which also conforms to the requirements of environmental protection nowadays. The whole system provides higher security on the operation of equipments and water quality by adopting the advanced online instrumentation control and man-machine dialog interface.
Its working flow is shown as the following:
Raw water- Raw water box -Multi-media filter -Precise filter -Primary reverse osmosis
Secondary reverse osmosis- EDI deionizer- Purified water tank
The raw water pre-treatment system in it is consisted of raw water supply, raw water box, raw water pump, multi-media filter and precise filter, which can effectively filter off suspending and gelatinous substances in the water. The precise filter can filter off particles with the diameter of over 5¦Ìm, thus it can protect the high-pressure pump and membrane from mechanical damage under the effect of high-pressure water flow.
By adopting the ultra-low pressure RO membrane ESPA2 (primary) and low-pressure high-desalination compound membrane CPA3 (secondary) which are produced by American Hydranautics Company, the RO desalination system has the features of extremely low operating pressure (which is decreased by 25%-40% in comparison with common the operating pressure of low-pressure compound membrane), higher water flux (its desalinization ratio is same as that of other compound membranes in large water flux) and wider water quality range and pressure quality range etc.
The electro-deionization (EDI) technology adopts the deionization process of electro-regeneration ion exchange and takes the place of traditional deionization (DI) process of mixed ion-exchange resin which needs the regeneration of acid and base. The combination of EDI technology and RO membrane separation technology can continuously produce highly purified water.
In order to ensure the water quality, we also install ultraviolet sterilizing equipments on the purified-water pipeline. In addition, we also specify that the pipeline should be given regular online pure-steam sterilization so as to ensure the clean of pipeline.
All indexes of purified water produced in all of our purified water systems are much higher than the national requirements on the purified water quality after the inspection of quality supervision authorities.
2. Water-for-injection system
In order to satisfy the requirements of production workshops, all the main workshops are equipped with corresponding production equipments of water for injection. The main production equipments are listed as the following:
Workshop nmae
Equipment name
Type
Water output
Functions
Vaccine workshop
Multi-effect water distiller
2t/h Provide water for washing, swilling and liquid distribution
Sub-package workshop
Multi-effect water distiller
1t/h Provide water for washing, swilling and sub-package line
QA Department
Electrical distiller
30l/h Provide water for experiments in the laboratory
The water-for-injection system is consisted of multi-effect water distiller, water-for-injection tank and 316L pipeline. Our company adopts the five-effect water distiller produced by Jilin Watertown Pharmaceutical Equipment Co., Ltd, and this kind of equipment takes the leading position presently in China. The distilled water, which is produced by the equipment by means of taking the purified water produced by the above-mentioned water distiller as feeding water and heating with industrial steam, has the features of stable quality, high purity, pyrogen free and lus/cm of conductivity, so it can meet the requirements of ¡°water for injection" in the China Pharmacopeias 2000. The water-for-injection can ensure that the water for injection is stored at the temperature of 80¡æ and circulated at the temperature of 65¡æ and can ensure the quality of process water by adopting the intercalated-bed steam incubation. The qualified 316L stainless steel materials and diaphragm valve are adopted for the whole water-for-injection pipeline, so it can prevent the water for injection from direct contact with outer environment. In addition, the whole pipeline system can be given online steam sterilization according to relevant requirements, which can ensure the quality of water for injection.
¢ù. Certificate for the Release of Biological Products issued by State Food and Drug Administration
¢ú. Photos of our company and workshops of each department
1. Factory area of our company
2. Vaccine workshop
Clean passage/cell culture greenhouse
3. Sub-package workshop/sub-package line
4. Experimental animal room
5. Storehouse
¢û. The vaccine containing adjuvant (aluminum hydroxide) is unsuitable to be given subcutaneous injection because the adverse reactions such as induration or inflammation can take place in the injection sites sometimes. The two kinds of intramuscular and subcutaneous injection methods can be adopted for the vaccines not containing adjuvant (aluminum hydroxide). The ¡°Forewell Biophram¡± Rabies Vaccine for Human use doesn¡¯t contain adjuvant, and is still used with the method of intramuscular injection in order to keep in line with the 2005 Edition Pharmacopoeia of the People's Republic of China which continues to adopt the previous intramuscular injection method.
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