冻干工艺中交叉污染，纯度不够等问题解答案例
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冻干工艺中交叉污染，纯度不够等问题解答案例
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2313
更新日期：
2023-10-30
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About ProJect Pharmaceutics GmbH
ProJect Pharmaceutics GmbH (PJP) offers optimized formulation and process development for pioneering drug products to the international pharmaceutical and biotech industry.
PJP was founded in 2010 and is located in Martinsried / Munich. The company has become the leading European service provider for the pharmaceutical development of cancer drugs, especially of so-called Antibody Drug Conjugates (ADCs). With these innovative agents, a highly cytotoxic agent is linked to a monoclonal antibody, which is to direct the active substance to the cancer cells in a targeted manner. For this type of drugs, PJP does not only delevop formulations but also efficient and robust manufacturing processes, which are scaled up from in-house pilot installations to industrial sterile manufacturing. In the process, PJP pursues a consequent “Quality by Design” approach, so that the drugs can be processed smoothly and in consistent high quality in the production plant.
The PJP team approached Teclen GmbH, who offers different products for contamination-free lyophilization, with this problem.
Initial situation
Freeze-drying is an essential step in the development and manufacturing of many drugs in order to increase the stability of active ingredients and to get a storable finished drug product. Especially cancer drugs with highly sensitive active ingrediences often imperatively require freeze-drying to avoid degradation and reduction of the effectiveness during storage. So far, the products have been freeze-dried in open glass vials. In this process, the contamination of the freeze-drier by potential fly-out of toxic material from the vial or by glass breakage poses a risk for the staff, and the higher cleaning effort and frequent change of the vacuum pump oil leads to a considerable increase of production costs. Trials to seal the lyophilizate in sterilization bags and to perform lyophilization from within such more or less gaspermeable bags were not successful. The considerable obstruction of the sublimate downflow at the bag’s membrane leads to massive changes in the process quality – efficient lyophilization is no longer guaranteed.
The solution: Lyprotect® Bag
When Dr. Andreas Schütz of PJP explained their present approach to Rolf Lenhardt of Teclen GmbH, a joint solution was found within no time:
The freeze-drying process was to be identical to the lyophilization process in an open vial to the extent possible. At the same time, it was to ensure total protection of the product and the environment. The specific Lyoprotect® Bag offers this advantage:
The entire assembly (usually a metal tray) of the vials can be inserted into the bag, the open side is closed with a special clip system. Subsequently, lyophilization of the vials is possible with exactly the same drying parameters used for lyophilzation with open containers. It has been demonstrated that there is no obstruction of the sublimate downflow.
Depending on the requirements, the bag can be sterilized in an autoclave before it is filled.
For vials and bulk
The Lyoprotect® Bag is characterized by an excellent vapor permeability; at the same time it reliably prevents bacteria, germs or particles from passing through the membrane.
As the Lyoprotect® Bag is very flexible, the vials can also be closed directly in the bag with the lyo-plugs by lowering the shelves, thus securely closing the vials.
Thorough tests performed by PJP confirm the excellent suitability of the Lyoprotect® Bag for lyophilization. By means of extensive test series, it was possible to verify the particle tightness of the bags even under extreme conditions. The drying process of sample vials within the Lyoprotect ® Bag was completely equivalent to the drying process with open vials. PJP now uses Lyoprotect® Bags for all projects with toxic ingredients and for all batches for the production of sterile preclinical samples.
Dr. Andreas Schütz states:
“We’d already tried out several sterilizationbags, but always had to compromise on the drying parameters. With Lyoprotect® our drying philosophy of the Single-Step-Cycle can now be realized much better – we also consider the Lyoprotect system fit for GMP production of lyophilized drugs.”
ProJect Pharmaceutics GmbH (PJP) offers optimized formulation and process development for pioneering drug products to the international pharmaceutical and biotech industry.
PJP was founded in 2010 and is located in Martinsried / Munich. The company has become the leading European service provider for the pharmaceutical development of cancer drugs, especially of so-called Antibody Drug Conjugates (ADCs). With these innovative agents, a highly cytotoxic agent is linked to a monoclonal antibody, which is to direct the active substance to the cancer cells in a targeted manner. For this type of drugs, PJP does not only delevop formulations but also efficient and robust manufacturing processes, which are scaled up from in-house pilot installations to industrial sterile manufacturing. In the process, PJP pursues a consequent “Quality by Design” approach, so that the drugs can be processed smoothly and in consistent high quality in the production plant.
The PJP team approached Teclen GmbH, who offers different products for contamination-free lyophilization, with this problem.
Initial situation
Freeze-drying is an essential step in the development and manufacturing of many drugs in order to increase the stability of active ingredients and to get a storable finished drug product. Especially cancer drugs with highly sensitive active ingrediences often imperatively require freeze-drying to avoid degradation and reduction of the effectiveness during storage. So far, the products have been freeze-dried in open glass vials. In this process, the contamination of the freeze-drier by potential fly-out of toxic material from the vial or by glass breakage poses a risk for the staff, and the higher cleaning effort and frequent change of the vacuum pump oil leads to a considerable increase of production costs. Trials to seal the lyophilizate in sterilization bags and to perform lyophilization from within such more or less gaspermeable bags were not successful. The considerable obstruction of the sublimate downflow at the bag’s membrane leads to massive changes in the process quality – efficient lyophilization is no longer guaranteed.
The solution: Lyprotect® Bag
When Dr. Andreas Schütz of PJP explained their present approach to Rolf Lenhardt of Teclen GmbH, a joint solution was found within no time:
The freeze-drying process was to be identical to the lyophilization process in an open vial to the extent possible. At the same time, it was to ensure total protection of the product and the environment. The specific Lyoprotect® Bag offers this advantage:
The entire assembly (usually a metal tray) of the vials can be inserted into the bag, the open side is closed with a special clip system. Subsequently, lyophilization of the vials is possible with exactly the same drying parameters used for lyophilzation with open containers. It has been demonstrated that there is no obstruction of the sublimate downflow.
Depending on the requirements, the bag can be sterilized in an autoclave before it is filled.
For vials and bulk
The Lyoprotect® Bag is characterized by an excellent vapor permeability; at the same time it reliably prevents bacteria, germs or particles from passing through the membrane.
As the Lyoprotect® Bag is very flexible, the vials can also be closed directly in the bag with the lyo-plugs by lowering the shelves, thus securely closing the vials.
Thorough tests performed by PJP confirm the excellent suitability of the Lyoprotect® Bag for lyophilization. By means of extensive test series, it was possible to verify the particle tightness of the bags even under extreme conditions. The drying process of sample vials within the Lyoprotect ® Bag was completely equivalent to the drying process with open vials. PJP now uses Lyoprotect® Bags for all projects with toxic ingredients and for all batches for the production of sterile preclinical samples.
Dr. Andreas Schütz states:
“We’d already tried out several sterilizationbags, but always had to compromise on the drying parameters. With Lyoprotect® our drying philosophy of the Single-Step-Cycle can now be realized much better – we also consider the Lyoprotect system fit for GMP production of lyophilized drugs.”
公司简介
斯沃德公司是一家专业性的生命科学仪器供应商，自成立以来，在广大用户的帮助与支持下，经过不懈努力，已成为中国生命科学领域产品的供应商之一，代理欧美等地专业生产厂家、具有国际先进水平的高科技产地产品，其产品涵盖分子，细胞，免疫，诊断等多个研究及应用领域。公司的服务网络遍及全国各地，在各大中城市建立了联络处，拥有包括仪器，专项产品，市场与技术支持，售后服务，后勤等多个部门组成的完整服务体系。
公司的规模和产品种类在日益扩展，我们仍将一如既往地秉承“以德为先，以德为上”、“专注技术、科研服务”的宗旨，力求在代理国际领先专业仪器、产品的同时，将最新最先进的技术方法推荐到用户，为广大客户提供包括技术咨询、产品选配、售后培训及维护的专业服务体系。代理以下产品(针对项目可提供资质文件与授权)
西班牙 coolvacuum （客慕）冷冻干燥机
西班牙bionet engineering （比欧耐科） 生物反应器，发酵罐
意大利 Flli Della 低温冰箱/培养箱/动物实验培养箱/植物实验培养箱/光照培养箱
瑞典 Belach Bioteknik AB 发酵罐系统
意大利fiocchetti (菲奥凯帝）制冰机，超低温冰箱，培养箱等
西班牙Myr( 麦瑞）组织脱水机，组织包埋机/组织染色机
德国teclan泰勒冻干机耗材，冻干杯，冻干袋，冻干机盘
售后服务
bionet engineering 代表处
fiocchetti代表处
西班牙coolvcuum 服务中
麦瑞（Myr)服务中心
德国microm病理服务
我公司有自己服务团队，可以胜任冻干机、发酵罐、离心机、病理设备、蛋白工作站、基因扩增等维护
服务电话 010-62894911、手机：13910235149
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