Datasheet
Primary Description: | Sheep Anti-c-Fos |
Target Antigen: | c-Fos |
Catalogue Number: | IQ589 |
Quantity: | 0.1ml |
Concentration: | 1mg/ml |
Host: | Sheep |
Immunogen: | Synthetic peptide conjugated to KLH, peptide sequence corresponds to the C-terminus of human c-Fos |
Species Reactivity: | Rat. Predicted to work with Human Mouse and Pig |
Purification: | Crude antiserum was purified by Thiopropyl Sepharose affinity chromatography |
Format: | Supplied in PBS containing 0.01% sodium azide and 1% trehalose |
Applications: | ELISA & Western blot |
Dilutions: | Optimal antibody dilution should be determined by titration, however as a guideline try;WB: 2ug/ml. Recognises a single band migrating at approximately 50 kDa |
Also Known As: | Activator protein 1 antibody;AP 1 antibody;Cellular oncogene c fos antibody;Cellular oncogene fos antibody;FBJ murine osteosarcoma viral (v fos) oncogene homolog (oncogene FOS) antibody;FBJ murine osteosarcoma viral v fos oncogene homolog antibody;FBJ Osteosarcoma Virus antibody;FOS antibody;FOS protein antibody;FOS_HUMAN antibody;G0 G1 switch regulatory protein 7 antibody;G0/G1 switch regulatory protein 7 antibody;G0S7 antibody;Oncogene FOS antibody;p55 antibody;proto oncogene c Fos antibody;Proto oncogene protein c fos antibody;Proto-oncogene c-Fos antibody;v fos FBJ murine osteosarcoma viral oncogene homolog antibody |
Protocols
Immunofluorescence protocol - Formaldehyde fixation
- Collect cells from T.c.unit and remove media from petri dish using suction.
- Wash with 1x PBS and remove.
- Incubate cells in pre-warm (37°C) Para-Formaldehyde for 12 minutes at room temperature on an orbital shaker.
- Remove PFA and incubate in 0.5% Triton X-IOO in 1x PBS for 5 minutes at room temperature.
- Prepare blocking reagent, this is also the antibody diluent.
- Wash cells 2x with 1x PBS at room temperature, for 4 minutes/wash on an orbital shaker.
- Block with 1 % NCS and 1x PBS for 30 minutes at room temperature.
- Prepare primary antibodies (50?l/coverslip) and moist staining chambers.
- Wash cells 2x with lx PBS at room temperature and air dry briefly.
- Incubate with primary antibody for 1 hr at room temperature in the dark in staining chambers. During this time prepare the secondary antibody.
- Wash cells 5x with 1x PBS (5 beaker changes/5 counts in each beaker)
- Incubate with secondary antibody for 1 hour at room temperature in the dark in staining chambers.
- Wash cells 5x with 1x PBS.
- Mount in Dapi.
Solutions (prepare fresh the same day of staining).
- * 1x Phosphate buffered saline.
- * Blocking reagent: 1% NCS in 1x PBS (use fresh l0x PBS).
- * Fixation solution: 3.5% Para formaldehyde.
1.75g PFA in 20 ml d.H20 plus 5 drops 1M NaOH. Stir on a hot plate at 50-60°C until dissolved. Add 4 drops IN HCI and check pH indicator strip. PH should be 7.4. Complete volume with d.H20 to 25ml and add 25ml 2xPBS. Check pH before adding to cover slips.
Immunofluorescence protocol - Methanol/acetone fixation
- Collect cells from T.C.unit and remove media from petri dish using suction.
- Wash with 1x PBS and remove.
- Fix cells with cold methanol: acetone 1: 1 for 10 minutes on ice.
- Prepare blocking reagent, this is also the diluent for the antibodies.
- Remove fixative and wash cells 3x with Ix PBS at RT, for 4 minutes/wash on orbital shaker.
- Block with 1% NCS and Ix PBS for 30 minutes at RT.
- Prepare primary antibodies (50?l/coverslip) and moist staining chambers.
- Wash cells 2x with 1 x PBS at RT and air dry for approximately 7 minutes.
- Incubate with primary antibody for 1 hr at RT in the dark in staining chambers.During this time prepare secondary antibody.
- Wash cells 5x with 1x PBS (5 beaker changes/5 counts in each beaker)
- Incubate with secondary antibody for 1 hr at R T in the dark in staining chambers.
- Wash cells 5x with 1x PBS.
- Mount in Dapi.
Solutions (prepare fresh the same day of staining)
- * 1x Phosphate buffered saline.
- * Blocking reagent: 1% NCS in 1x PBS (use fresh 10x PBS).
- * Fixation solution: methanol:acetone 1: 1 ice cold.
Western Blotting Protocol
- Transfer gel to PDVF or nitrocellulose membrane
- Place membrane in plastic tray in blocking buffer for one hour with agitation
- Rinse in wash buffer
- Incubate in wash buffer plus primary antibody for one hour
- Wash 6 X 5 minutes with wash buffer
- Incubate in wash buffer plus secondary antibody for one hour
- Wash 6X 5 minutes with wash buffer
- Detect (e.g. ECL, Amersham according to manufacturers instructions)
Wash buffer
PBS + 0.1% Tween 20
Blocking buffer
Wash buffer + 5% dried milk powder
The concentration of antibodies used depends on each antibody, the amount of antigen and the detection method used. Generally, dilution is in the range of a few hundred times dilution to a few thousand times dilution, but usually has to be determined empirically.
FAQ"s
How do I place an order?
When placing an order we require a purchase order number, plus name and contact details of the purchaser, and the person who will be using the product. We will add VAT for every order received from an EU country, unless you are VAT exempt. For such VAT exempt customers we will need to receive a copy of the exemption certificate with the order.Orders can be placed either by our website, via email or by mail. Please see our contact us page for more detailsAll orders are subject to availability. Prices of products do not include shipping, VAT or import duties, where these are applicable.Price and other information provided are subject to change without notice. While every effort is made to keep information provided Up to date, ImmuQuest will not be liable if errors should occur in such information.Formal acceptance of an order will take place when the goods are dispatched. If prices should be changed between the time of receipt of an order and dispatch, ImmuQuest will contact you in advance.
Ordering via the website
To order via the website you will need to find the product(s) you are looking for by either using our search, browsing our categories or using our full antibody catalogue.Once you have found the antibodies you are looking for you can view more detailed information about a specific antibody by clicking the product or the "View" button. Once you are sure it is the antibody you are looking for you can add it to your order by clicking the "Add To Order" button.This places the antibody in your order basket, you can add as many antibodies as you wish. Once you have selected all of the antibodies you wish to order then click the checkout button. If you are not logged in you will be asked to login or to register, if you are logged in you will be taken to the checkout page.On the checkout page you are able to double check your order and enter a purchase order number if you have one.Once you are happy your order is correct you can purchase the order with debit/credit card details and your order will be submitted. Once we have received and checked your order we will contact you to arrange payment and delivery.
How long does delivery take?
Delivery usually takes no more than one week from reciept of an order.
Do you guarantee your antibodies?
Yes. Should any product not perform as described in the product literature, it will be replaced or a full refund will be given. The customer must notify ImmuQuest within 30 days after the goods have been received to request a replacement, forwarding complete test data as requested by ImmuQuest.If items are ordered incorrectly by the customer, ImmuQuest will consider taking them back as long as they have been stored correctly and have not been opened or tampered with. Such orders may be subject to a 15% restocking charge on the items plus any shipping costs.Requests for returns must have prior authorization from ImmuQuest, and must be made within 7 days of receipt of the items. Items must be returned in the same or equivalent packaging as originally dispatched, and by an equivalent method of delivery.
Do you charge VAT?
If you are in the EU and you are no exempt from paying VAT then we must charge VAT (charged at the prevailing UK rate).Customers that are exempt need to fax an exemption form showing their vat exemption number.
What if I don"t have a purchase order number?
You can still place an order without providing a purchase order number but we must recieve payment before your order is despatched.
Non-website orders
Non-website orders can be placed directly with Immuquest at sales@immuquest.com or click on the "contact us" tab for address details
Delivery
Offline Orders
For offline orders please call +44 (0) 1642 713533 or click here to email us.
Delivery & returns
We use federal Express for UK & international shipments, andfor standard shipments the cost is £30 UK & £55 international. If the customer uses their account, we charge a £20 handling fee (UK & international)We are strongly committed to providing the best quality products, and the best service possible.Should any product not perform as described in the product literature, it will be replaced or a full refund will be given. The customer must notify ImmuQuest within 30 days after the goods have been received to request a replacement, forwarding complete test data as requested by ImmuQuest.If items are ordered incorrectly by the customer, ImmuQuest will consider taking them back as long as they have been stored correctly and have not been opened or tampered with. Such orders may be subject to a 15% restocking charge on the items plus any shipping costs.Requests for returns must have prior authorization from ImmuQuest, and must be made within 7 days of receipt of the items. Items must be returned in the same or equivalent packaging as originally dispatched, and by an equivalent method of delivery.
Product Garantee
We are strongly committed to providing the best quality products, and the best service possible. In order to do this we depend on your feedback.Should any product not perform as described in the product literature, it will be replaced or a full refund will be given. The customer must notify ImmuQuest within 30 days after the goods have been received to request a replacement, forwarding complete test data as requested by ImmuQuest.If items are ordered incorrectly by the customer, ImmuQuest will consider taking them back as long as they have been stored correctly and have not been opened or tampered with. Such orders may be subject to a 15% restocking charge on the items plus any shipping costs.Requests for returns must have prior authorization from ImmuQuest, and must be made within 7 days of receipt of the items. Items must be returned in the same or equivalent packaging as originally dispatched, and by an equivalent method of delivery.If you have any questions please contact us using the following details:ImmuQuest Ltd26 The GreenSeamerNorth YorkshireTS9 5LPUKTel: 01642 713533Fax: 01642 713988International Tel: +44 1642 713533International Fax: +44 1642 713988When placing an order ImmuQuest require a purchase order number, plus name and contact details of the purchaser, and the person who will be using the product. ImmuQuest will also need a VAT number for customers in the European Union.UK customers that are VAT exempt need to fax an exemption certificate.Orders can be placed either by our website, via email or by mail. Please see our contact us page for more details. All orders are subject to availability. Prices of products do not include shipping, VAT or import duties where these are applicable.Price and other information provided are subject to change without notice. While every effort is made to keep information provided Up to date, ImmuQuest will not be liable if errors should occur in such information. Formal acceptance of an order will take place when the goods are dispatched. If prices should be changed between the time of receipt of an order and dispatch, ImmuQuest will contact you in advance.
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华北制药完成重组人源抗狂犬病毒单克隆抗体注射液I期临床
2013-10-25
近日,由华北制药集团新药研究开发有限责任公司(以下简称华北制药新药公司)开发研制的国家一类新药重组人源抗狂犬病毒单克隆抗体(rhRIG),完成I期人体临床试验,即将启动II期临床试验。
作为我国第一个具有自主知识产权的重组人源抗体,I期临床试验结果表明,健康受试者对重组人源抗狂犬病毒单抗注射液的耐受性良好,药物在人体的安全性得到了初步确证。
与当前市售的狂犬病毒免疫球蛋白相比,重组人源狂犬病毒单克隆抗体以其对人体无免疫原性、无污染源、可连续规模生产等优势将逐渐成为预防狂犬病的具有良好应用前景的新产品。华北制药新药公司依托抗体药物研制国家重点实验室,经过多年研发,2009年,重组人源抗狂犬病毒单抗注射液获国家食品药品监督管理局新药人体临床试验批件,成为我国第一个具有自主知识产权的重组人源抗体的临床试验批件。
高健/文
详细原因细胞生物学产品专家齐氏生物整理如下:
目前,多种表达系统均可实现重组抗体的异源表达,但是抗体药物的产业化制备,始终以动物细胞大规模培养工艺为主。1986年首个治疗性抗体OKT3TM上市之初,动物细胞表达水平普遍不足100mg/L。经过近三十年间发展,业内用于重组抗体生产的动物细胞培养工艺,无论细胞培养密度,还是抗体表达水平均提高五十倍以上。流加培养工艺中细胞密度可达1~2×107 cell/mL,日均产量200mg/L/day以上(最高可达700mg/L/D),最终收液的容积产率可达3-5g/L(最高达13g/L),培养体积可至20,000L(Lonza, Portsmouth/NH—facility);灌注培养工艺中细胞密度可达2×108cell/ml,抗体容积产率最高达25~40g/L(Percivia公司XD?灌注系统)。以上行业技术水平的飞速提升,既源于上游细胞系构建技术的突破,也得益于细胞大规模培养工艺的日臻成熟。尤其是后者综合培养基开发,工艺优化,结合新型生物反应器的使用,实现了动物细胞的高密度、高表达培养,满足了临床上对于抗体药物“公斤级”产能的需求。
动物细胞的体外培养,涉及生物反应器的物理参数(温度、pH、DO、DCO2等)、培养基的营养成分(葡萄糖、谷氨酰胺、氨基酸、维生素等)的消耗,以及自身代谢产物(乳酸、氨、重组蛋白等)的积累与生理生化参数(细胞密度、活性,能荷等)的变化。作为重组抗体生产的“细胞工厂”,上述过程参数的改变会直接影响生产细胞系的活性与重组抗体的收率。比如:当乳酸(58 mM)、渗透压(382 mOsm/kg)、氨(5.1 mM)参数超过其相应的阈值,细胞活性和抗体产量均会明显下降。目前,业内已经对于细胞培养过程参数进行了深入的研究,在动物细胞大规模培养中下述参数的控制也已成定式
随着组学技术的发展与应用,目前的细胞培养工艺开发,已经从简单的工艺参数优化,进入系统的组学研究深度,生产细胞的代谢网络与重组抗体合成机制日益清晰。对于生产细胞系在不同工艺条件下抗体产量的差异,已经能够从基因组、蛋白组、代谢组等不同层次进行分析、解释。这就为今后大规模细胞培养工艺开发提供了新的线索。同时,业内随着“QbD”理念的深入,越来越多的“过程分析技术”(Process analytical technologies)开始应用于细胞培养过程,旨在通过加强关键过程参数的监控来确保蛋白药物的最终质量。如:培养基检测、培养过程监控、多批次数据分析等。未来基于重组抗体表达的细胞大规模培养工艺开发,将朝着稳定产能,提高质量的方向发展。
分子式:C6428H9976N1720O2018S42 (仅多肽部分)
分子量:144 985 Da (仅多肽部分)
辅料包括:蔗糖、聚山梨酯80、十二水合磷酸氢二钠、二水合磷酸二氢钠和注射用水。
【性状】:澄清至半透明的无色至淡黄色液体。
参考资料:http://baike.baidu.com/view/10489361.htm
无论是保存还是运输,请避免反复冻融。反复冻融,冰晶会破坏抗体和重组蛋白的空间结构,导致蛋白变性形成多聚体和重组蛋白构象改变,从而降低抗体的结合能力,也加快了抗体球蛋白和重组蛋白的降解速度。抗体和重组蛋白保存得当与否,直接决定了抗体和重组蛋白的活性使用效果,如果保存得当,Immunetech(苏州杰恩生物)的抗体和重组蛋白活性大部分都可以维持数年。
1.收到抗体和重组蛋白后的操作
收到抗体和重组蛋白后(大部分抗体和重组蛋白是溶液态),请务必在4℃,12000rpm,离心3分钟,再打开管盖进行分装、溶解和保存(如果抗体和重组蛋白体积小于50µl,请延长离心时间至5分钟,以保证全部抗体和重组蛋白均离心下来,干粉状态的同样适用)。Immunetech的抗体和重组蛋白使用特制的储存管,只有在12000rpm离心3分钟,才能将附着在管壁或盖内的抗体和重组蛋白全部离心下来(即使是在10000rpm离心也会离心不完全,导致出现抗体和重组蛋白的量不足的现象)。请详细阅读说明书,并按照推荐的保存条件正确保存和使用抗体和重组蛋白。
2.抗体和重组蛋白的长期保存
对于Immunetech(苏州杰恩生物)大部分抗体和重组蛋白,比较合适的保存方式是:抗体分装后保存在-20℃,重组蛋白分装后保存在-80℃。
(1)分装可以最大程度的降低反复冻融对抗体和重组蛋白活性的损害,同时也降低了由于多次从同一管中吸取抗体和重组蛋白造成的污染可能性。
(2)分装的量以一次实验用完为好,最少不能少于10µl每份。因为分装体积越小,抗体和重组蛋白的浓度越可能会受到蒸发以及管壁吸附的影响。
(3)复融后的分装抗体和重组蛋白如果一次用不完,将剩余母液保存在4℃,避免再冻起来。
(4)抗体和重组蛋白工作液应该当天配制当天用完,4℃保存尽量不要超过1天。
(5)绝对避免将抗体和重组蛋白保存在自动除霜冰箱中,将抗体和重组蛋白保存在冰箱里层,避免温度变化造成反复冻融。
3.抗体和重组蛋白的短期保存
大部分Immunetech(苏州杰恩生物)的抗体和重组蛋白收到后4℃短暂保存1~2周,对抗体和重组蛋白活性没有影响。如果抗体和重组蛋白很快会使用(1~2周内),推荐在4℃保存,这是为了避免反复冻融对抗体和重组蛋白活性的损害。最关键的一点是要根据说明书推荐的方式来正确的保存抗体和重组蛋白。
4.抗体和重组蛋白的运输条件
一般的运输过程需要1~2周的时间,所以是在低温4℃的条件下来完成的。4℃运输最主要的目的是为了避免反复冻融对抗体和重组蛋白活性的损害(如果使用干冰运输,那么收到时抗体和重组蛋白是冻起来的,为了分装就需要解冻,这就多了一次冻融的过程),所以运输过程中一般避免干冰运输。
5.抗体和重组蛋白的稳定性
(1)抗体的稳定性是自然界长期进化的结果,抗体是免疫系统中最重要的分子之一,其稳定性是自然进化筛选的结果,在众多物种中,抗体分子形成了保守而稳定的结构。
(2)抗体的高Tm值,在室温下,甚至短时间温度达到50~60℃,抗体分子都能维持正确折叠,保持其应有的活性。
(3)抗体和重组蛋白的纯度。Immunetech采用先进的抗体和重组蛋白纯化技术,确保抗体和重组蛋白产品的高纯度,保障其抗体和重组蛋白产品的稳定性。
(4)抗体和重组蛋白的浓度。高浓度的抗体和重组蛋白产品可减少容器表面吸附造成的物质损失,高浓度的抗体和重组蛋白稳定性更好。Immunetech大部分抗体和重组蛋白浓度为1mg/ml,抗体和重组蛋白纯度高,特异性好,效价更高。
6.重组蛋白的特性
Immunetech(苏州杰恩生物)的重组蛋白分为冻干粉和溶液态两种保存形式,原核细胞表达的重组蛋白为冻干粉状态,真核细胞表达的重组蛋白为溶液态保存,这样使得重组蛋白非常稳定,在-80℃条件下可保存数年。冻干粉在使用前需进行溶解,其中溶解的方法非常关键,因为溶解不好会降低蛋白的效用。溶液态保存的重组蛋白在冻融稀释使用过程中也需要仔细注意,这些都是用户在实际应用中经常遇到的问题。
(1)原核细胞表达的重组蛋白。Immunetech大肠杆菌表达的冻干重组蛋白,已经从包涵体中提纯,添加了蛋白保护剂,使用过滤后的无菌水作为复溶剂即可,复溶冻干蛋白100µg,用86µl的超纯水,轻轻摇晃使蛋白溶解,再用移液枪的枪头轻吹几下即可完全溶解,一定不能使用涡旋仪进行快速振荡或剧烈摇晃。
(2)真核细胞表达的重组蛋白。有活性的蛋白质不仅要转录和翻译,还要进行翻译后的加工,使得蛋白质的空间折叠方式维持正常,所以重组蛋白必须在真核细胞中进行,如哺乳动物细胞能够识别和去除基因中的内含子,对翻译后的蛋白质进行加工,这样表达的蛋白质具有生物活性。我们用溶液态来保存,保持了其良好的活性和稳定性。
(3)重组蛋白的保护剂。在冻干和储存过程中常用的保护剂或稳定剂有糖类,多元醇,聚合物,表面活性剂,某些蛋白和氨基酸等。我们通常加8%(质量比体积)的海藻糖和甘露醇作为冻干保护剂。海藻糖可明显阻止蛋白质二级结构改变以及冻干过程中蛋白质的伸展和聚集,甘露醇也是一种普遍应用的冻干保护剂和填充剂。
2012-07-20
狂犬病,以100%的病死率令人谈之色变。如今,随着华北制药重组人源抗狂犬病毒抗体的研制成功,狂犬病的高发状况将得到有效缓解。
基因序列全部来源于人,依靠基因重组技术生产,抗体注入人体后有效降低排异反应,达到应急预防目的,弥补了被狗咬伤与注射狂犬疫苗后产生主动性抗体之间时段无抗体的空白。由世界500强企业冀中能源[15.08
-2.46%股吧
研报]集团旗下华北制药抗体药物研制国家重点实验室主导,我国第一个拥有自主知识产权的重组人源抗狂犬病毒抗体,已经获得国家药监局临床批文并顺利进入临床研究阶段。
“基因重组人源抗体这一**性的技术突破,将使成功防治病毒性和细菌性感染疾病成为可能。”冀中能源集团董事长、党委书记,华北制药集团董事长、党委书记王社平颇感自豪地讲到:“我们科技创新正由投入驱动向创新驱动转变,正以自主研发的技术平台体系,为华药产业升级、迈向高端提供重要科技支撑和强有力推动。”
从人血清到重组人源抗体消除人体免疫系统的排异反应,最大限度地提高药效,用药量仅为原来的千分之一重组人源抗体一直是我国抗体技术攻关的主要方向。目前,就狂犬病而言,常用的抗狂犬病毒抗体是来源于人血的抗狂犬病毒血清,从人血浆中提取制备,不但存在异源蛋白的免疫反应,而且市场供应量受血浆来源限制,并具有潜在血源污染等问题,严重影响了狂犬病的防治需求。而重组人源抗体的基因序列全部来源于人体,可以最大程度消除人体免疫系统对异源性蛋白的排异反应。根据狂犬病控制联盟和美国疾病控制与预防中心报告,全球每年因狂犬病死亡的人数高达5.5万人,即平均每10分钟有1人死于狂犬病。我国属于狂犬病的高发国家之一,近十年来每年病例数在2000-3000例,仅次于印度,居世界第二。按照标准的免疫程序(五针)注射狂犬疫苗后,80%的人群在14天左右才能产生足够量的抗体抵制狂犬病毒的侵袭,还有20%左右的人群即便打过疫苗也无法产生抗体。据悉,在主动免疫抗体产生的空当,病毒会以每小时5毫米的速度向中枢神经转移,一旦进入脑部就会最终致人发病死亡,这对于头面部、颈部或手部多处被狗咬伤的严重病人及儿童更具有杀伤力。因此,在人体没有建立起自身抗体防御系统之前,寻找到一种能马上起效且作用强大的被动性外源抗体,阻断狂犬病毒感染尤显得尤为重要。但是,由于血源来源量的限制,目前市场上抗狂犬病毒免疫球蛋白药物不能大量生产,不足50万人份的市场供应量,远远不能满足每年800万人份的需求。而且使用这种抗体,以一个60公斤的成年人计算,一次注射至少要1500元,价格比较昂贵。这些制约因素,使重组人源抗体的研发显得更为迫切。华北制药从2003年进入重组人源抗体研究领域到如今重组人源抗狂犬病毒抗体的成功研制,打破了少数国家的封锁和垄断,使我国在这一技术上达到国际领先水平。“重组人源抗体基因序列全部来源于人,就像给抗体装上了一把****,很容易获取人体的信任,与病毒主动结合,诱导我们的免疫系统把这些外来侵略者杀掉。”华北制药抗体药物研制国家重点实验室主任高健尽可能浅显地解释这项新技术:重组人源抗体的结构和人自身的抗体结构一模一样,从而能消除人体免疫系统的排异反应,最大限度地提高药效。“原来需要注射1g血源抗狂犬病免疫球蛋白,现在1mg重组人源抗狂犬病毒抗体就已足够,剂量是原来的千分之一。”
生产老百姓用得起的抗体售价可降低三分之二,带来上亿元效益“我们要生产中国老百姓都用得起的抗体”。高健称,狂犬抗体用重组方式生产将不再需要从人血中提取,从而解决了血源来源稀少的问题,价格也大幅度降低,使大批量生产成为可能。“可别小看这小小一支药,投产后初期产量预计100万人份,每人份售价即使按血源免疫球蛋白制品售价三分之一计算,每年就将给华药带来上亿元实实在在的效益。”华北制药新药研发公司总经理段宝玲说,我们希望通过重组人源抗狂犬病毒抗体的研制带动华药产业升级。技术虽然得到突破,但生产工艺一直受制于人。“如今我们在新型生物反应器技术研发上已有很大进展,正在代替过去的细胞转瓶生产工艺。”高健解释,以前疫苗生产过程中需要集中许多小转瓶培养细胞,而现在,一个50升的反应器就可以替代上千个转瓶的工作量,不仅提高了产品质量的均一性,而且能大幅提高生产能力,降低综合成本。“该技术已在多个疫苗产品的生产中进行了应用试验,成熟后可以实现国产化替代,为新抗体的大批量生产提供保障。”“重组人源抗狂犬病毒抗体的研发成功,将打开一个更广阔的产业空间,可以促进其他蛋白药物的研制及后续新抗体药物的研发。”高健透露,重组全人源抗体技术的突破将为病毒感染类疾病提供**性的治疗手段。“这有利于引领国内生物制药的技术升级与改造,实现我国在抗体药物开发技术领域的跨越式发展,改变我国生物技术药物低水平重复的局面。”创新没有终点,目前在华药抗体药物研制国家重点实验室,识别病毒能力更强的狂犬病毒抗体第二代产品正在紧张地研发中。
(凤凰网2012年7月20日)