Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti

Xuri Cell Expansion System W25

Girgin Ltd — Tue, 13 Feb 2018 23:14:09 +0000

Xuri Hücre Genişletme Sistemi W25, araştırma, süreç geliştirme ve üretim operasyonları boyunca 25 L’ye kadar hacimlerde hücre tedavilerinin geliştirilmesi için otomatik, kontrollü bir genişleme ortamı sunar.

Kapalı sistem, hücre kontaminasyonu riskini en aza indirir.
Otomatik perfüzyon protokolleri yoluyla yüksek hücre yoğunlukları.
Süreçler gelişmiş kontrol yetenekleri ve UNICORN yazılımı aracılığıyla uzaktan çalıştırma / izleme vasıtasıyla kontrol altında kalır.
Düzenlenmiş bir ortamda kullanım için uygundur.
Düşük invaziv olmayan ortamda invaziv olmayan karıştırma, ortam perfüzyonu ve verimli oksijen transferi ile, 25 L hacimde> 10 x 106 hücre / mL elde edin.

Bu işlevsel olarak kapalı sistem, kontamine olma riskini en aza indirirken yüksek hücre yoğunluklarına neden olan, kültüre yumuşak bir karışım ve havalandırma sağlayan kurulu WAVE salınım teknolojisine dayalıdır.

Görmek inanmaktır

Xulan Hücre Genişletme Sistemi W25 ile hücre tedavisi üretim prosesinin en iyi hale getirilmesine ilişkin adım adım rehber için hücre terapisi üretimi için T hücrelerinin en iyi nasıl yetiştirileceği videoyu izleyin .

Elle aktarmalara elveda

Tekli biyolojik reaktörde tüm terapötik dozun sağlanmasını teminen 25 L’ye kadar çalışma hacimlerini barındırabilen tek kullanımlık Cellbag biyoreaktörler kullanılarak sıkıcı ardışık transferler olmaksızın ölçeklendirme. Bu sayede kontaminasyon ve operatör değişkenliği riskini azaltır, aynı zamanda zaman ve çalışma alanınızı da boşa çıkarır.

Proses parametrelerini kontrol altına alır

Salınım hızı, çözünmüş oksijen (DO), pH ve perfüzyon hızı gibi proses parametreleri ya yerel olarak ya da uzaktan kontrol edilir ve kontrol edilir. Önceden belirlenmiş koşullar yerine getirildiğinde veya tanımlanmış parametrelerden sapmalar olduğunda alarmlar yapılandırılabilirken yöntemler oluşturulabilir, düzenlenebilir ve kaydedilebilir.

Mevzuata uygunluğu destekler

Dahil edilmiş ve ek belgeler, opsiyonel kurulum ve işletim yeterlilik (IQ / OQ) hizmetleri artı 21 CFR Part 11 ve GAMP (Good Automated Manufacturing Practice) 5 uyumlu hazır UNICORN yazılımı, sisteminizin düzenlenen bir çevre şartlarını ve standartlarını karşıladığını garantiler.

Ürün Broşürü :

W25-Xuri-Cell Expansion-System

Orjinal Metin :

The Xuri Cell Expansion System W25 delivers an automated, controlled expansion environment for the growth of cell therapies in volumes up to 25 L across research, process development, and manufacturing operations.

Closed system minimizes risk of cell contamination.
High cell densities through automated perfusion protocols.
Processes stay in control through advanced control capabilities and remote operation/monitoring via UNICORN software.
Suitable for use in a regulated environment.
Achieve >10 x 106 cells/mL, in volumes up to 25 L, with non-invasive mixing, media perfusion, and efficient oxygen transfer in a low-sheer environment.

This functionally closed system is based on established WAVE rocking technology that provides gentle mixing and aeration to the culture, resulting in high cell densities whilst minimizing the risk of contamination.

Seeing is believing

Watch the video How to best culture T cells for cell therapy manufacturing for a step-by-step guide on how to optimize your cell therapy manufacturing process with Xuri Cell Expansion System W25.

Goodbye to manual transfers

Scale-up without tedious sequential transfers using single-use Cellbag bioreactors that can accommodate working volumes up to 25 L, ensuring an entire therapeutic dose can be obtained in a single bioreactor. This not only reduces the risk of contamination and operator variability but frees up your time and work space too.

Take control of process parameters

Process parameters such as rocking speed, dissolved oxygen (DO), pH, and perfusion rate are monitored and controlled either locally or remotely. Methods can be created, edited and saved while alarms can be configured to alert you when pre-set conditions are met or deviations from defined parameters occur.

Supports regulatory compliance

Included and supplemental documentation, optional installation and operational qualification (IQ/OQ) services, plus 21 CFR Part 11 and Good Automated Manufacturing Practice (GAMP) 5 compliant ready UNICORN software ensure your system meets the demands and standards of a regulated envfironment.

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Xuri T Cell Expansion

Girgin Ltd — Mon, 12 Feb 2018 23:53:23 +0000

İnsan T lenfositlerinin hücre genişlemesini sağlar. Hücre terapisi yardımcı materyali için USP <1043> takip eder.

Hızlı üretim için hızlı hücre çoğalması.
Entegre hortumlar ve işlevsel olarak kapalı sistem bağlantılarına izin veren portlar.
Toplu işler boyunca tutarlı performans.
Ex vivo ekim için USP <1043’ü takiben yardımcı hücre terapisi yardımcı ürünü.

Hızlı üretim için hızlı hücre çoğalması

Xuri T hücre genişleme ortamı, yaşayan insan T lenfositlerinin yüksek hücre yoğunluklarına artmış hızlanmasını sağlar. Yetiştirme zamanı daha esnek hale gelir ve donör değişkenliği nedeniyle zorlu hücrelerle çalışırken bile istenen hücre sayısının daha hızlı erişmesini sağlar.

İşlevsel olarak kapalı bir sistemle riski azaltın

Xuri T hücre genişleme ortamı, tıbbi sınıf PVC boru donanımlı torbalar ve erkek ve dişi Luer kilit bağlantı noktaları ile donatılmış olarak gönderilir ve torbanın Xuri cellbag biyoreaktörlerine steril olarak kaynak yapılabileceğinden emin olunur. Bu, işlevsel olarak kapalı bir sistem içerisinde çantaya takviyeleri ekleme esnekliği sağlar.

Tutarlı performans için değişkenliği en aza indirin

Xuri T hücre genişleme ortamı, sıkı bir kalite yönetim sistemi altında üretilir ve tamamen onaylanmış üretim süreci, toplu halde tutarlılık sağlar ve istenilen hücre sayılarına ulaşmada kontrolü geliştirir.

USP <1043> uyumluluğu

Hücre terapisi düzenleyici gerekliliklerle uğraşırken, düzgün bir gönderme süreci anahtardır. Kullanıcıların üretim süreçlerini değerlendirmesine ve belgelemelerine yardımcı olmak için Cytiva, USP <1043> ‘e ait hücre, gen ve doku mühendisliğindeki ürünler için yardımcı malzemeleri karşılayan kapsamlı bir dokümantasyon destek paketi ile Xuri T hücre genleşmesi ürününü tedarik eder ve bu ürünün sorumlulukları tedarikçisi.

Son kullanıcı sorumluluğu

USP <1043> ‘ün diğer yönleri de son kullanıcıya aittir. Cytiva, uygulama ve terapiye özgü yönleri (ör., Bitmiş terapötik kullanım, bitmiş terapötik ve muhtemelen biyouyumluluk, sitotoksisite veya yabancı maddelerin test edilmesinin değerlendirilmesi) açısından USP <1043> ‘yi yerine getiremez. Ürün kimyasal olarak tanımlanmıştır ve herhangi bir insan veya hayvan türevi bileşen içermez.

Ürün Broşürü :

Xuri-T-Cell-Expansion-Medium

Xuri-T-Cell-Expansion-Media-Protocol

Xuri-T-Cell Expansion-Media IM-

Orjinal Metin :

Enables cell expansion of human T lymphocytes. It follows USP <1043> for cell therapy ancillary material.

Rapid cell proliferation for faster manufacturing.
Integrated tubing and ports allowing functionally closed system connections.
Consistent performance across batches.
Dedicated cell therapy ancillary product following USP<1043> for ex vivo cultivation.

Rapid cell proliferation for faster manufacturing

Xuri T cell expansion medium enables elevated rates of proliferation of viable human T lymphocytes to high cell densities. Cultivation time becomes more flexible, enabling the reach of the desired cell number faster even when working with challenging cells due to donor variability.

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UCB-HES

Girgin Ltd — Tue, 23 Jan 2018 05:15:18 +0000

Product #14200

Our protocol software provides a fully-automated method to separate cellular product into its components in combination with our Sepax Cell Separation System. It enables a reproducible and user independent procedure.

UCB-HES is a protocol designed for concentrating the nucleated cell fraction from Umbilical Cord Blood (UCB) into a selectable final volume of 20-50 mL using Hydroxyethyl Starch (HES) sedimentation agent.

The sedimentation profile of the UCB-HES protocol has been designed to deliver high performances for a wide range of initial product characteristics, with reproducible final volumes.

Key features

UCB-HES features
Initial volume	35 to 320 mL
Selectable final volume	20 to 50 mL
Processing time	~ 35 minutes
Average TNC recovery	85 to 99 %
Average CD34+ recovery	90 to 99%

Workflow

Step	Details
1	Prepare a kit with the initial product.
2	Install the kit on the Sepax.
3	The Sepax automatically performs the procedure.
3	Collect the final product.

Product features

Use both mono stopcock (reduced) or three stopcock (standard) kits.
Separation profile customized to each cords’ unique characteristics.
Traceability IDs: Use the Sepax traceability kit (barcode reader + printer) to track specific identification criteria.
Summary print-out: Print reports at the end of procedures with the Sepax traceability kit (barcode reader + printer).
Main user interface available in: Chinese, English, French, German, Italian, and Spanish.

Kit / protocol compatibility matrix

Kit / protocol	CS-530.1	CS-530.4 /.4b	CS-540.4 /.4b	CS-570.4	CS-570.1m	CS-570.4mb	CS-570.3m	CS-430.1
UCB	x	x	x	x	x	x	x	x
UCB-HES	x	x	x	x	x	x	x	x

Ordering information

UCB-HES: Product #14200

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

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UCB

Girgin Ltd — Tue, 23 Jan 2018 05:14:37 +0000

Product #14201

UCB is a protocol designed for concentrating the nucleated cell fraction from Umbilical Cord Blood (UCB) into a selectable final volume of 10-50 mL without the use of a sedimentation agent.

The sedimentation profile of the UCB protocol has been designed to deliver high performances for a wide range of initial product characteristics, with reproducible final volumes.

Key features

UCB features
Initial volume	35 to 290 mL
Selectable final volume	10 to 50 mL
Processing time	~ 45 minutes
Average TNC recovery	80% – 99%
Average CD34+ recovery	85% – 99% (depending on initial cell count)

Workflow

Step	Details
1	Prepare a kit with the initial product.
2	Install the kit on the Sepax.
3	The Sepax automatically performs the procedure.
3	Collect the final product.

Product features

Use both mono stopcock (reduced) or three stopcock (standard) kits.
Separation profile customized to each cords’ unique characteristics.
Traceability IDs: Use the Sepax traceability kit (barcode reader + printer) to track specific identification criteria.
Summary print-out: Print reports at the end of procedures with the Sepax traceability kit (barcode reader + printer).
Main user interface available in: Chinese, English, French, German, Italian, and Spanish.

Kit / protocol compatibility matrix

Kit / protocol	CS-530.1	CS-530.4 /.4b	CS-540.4 /.4b	CS-570.4	CS-570.1m	CS-570.4mb	CS-570.3m	CS-430.1
UCB	x	x	x	x	x	x	x	x
UCB-HES	x	x	x	x	x	x	x	x

Ordering information

UCB: Product #14201

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post UCB first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

SmartRedux

Girgin Ltd — Tue, 23 Jan 2018 05:14:01 +0000

Product #14301

SmartRedux is a protocol designed for concentrating the nucleated cell fraction from various cellular products, processing an initial volume up to 3300 mL.

The SmartRedux protocol is particularly suitable for bone marrow volume reduction, due to the wide range of initial and final volumes.

Key features

SmartRedux features
Initial volume	30 to 3300 mL
Selectable final volume	up to 1500 mL
Average TNC recovery	> 75% (linked to applied concentration ratio)

Workflow

Step	Details
1	After bone marrow aspiration and filtration, connect initial product to the kit.
2	Install the kit on the Sepax.
3	The Sepax automatically performs the procedure.
4	Collect the concentrated cells from the final product bag.

Product features

Fixed or proportional option available for the final volume, to fit different needs.
Additional plasma parameter to optimize final buffy coat characteristics.
Traceability IDs: Use the Sepax traceability kit (barcode reader + printer) to track specific identification criteria.
Summary print-out: Print reports at the end of procedures with the Sepax traceability kit (barcode reader + printer).
Main user interface available in: English, French, German, Italian, and Spanish.

Kit / protocol compatibility matrix

Kit / protocol	CS-490.1	CS-470.1	CS-900.2	CS-430.1*
PeriCell	x	–	–	x
SmartRedux	x	–	–	–
ReadyCell	–	x	–	–
NeatCell	–	–	x	–
Adipose	–	–	x	–

*Maximum initial volume limited to 600 mL.

Ordering information

SmartRedux: Product #14301

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post SmartRedux first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

ReadyCell

Girgin Ltd — Tue, 23 Jan 2018 05:13:26 +0000

Product #14302

ReadyCell is a protocol designed for concentrating the nucleated cell fraction from various cellular products into a small final volumes of 7-20 mL. It is particularly suitable for bone marrow concentration in point of care scenarios.

Key features

ReadyCell features
Initial volume	30 to 220 mL
Selectable final volume	7 to 20 mL
Processing time	~ 15 minutes
TNC concentration factor	Between 3 and 10

Workflow

Step	Details
1	After bone marrow aspiration and filtration, connect initial product to the kit.
2	Install the kit on the Sepax.
3	The Sepax automatically performs the procedure.
4	Collect concentrated cells from the final product vial.

Product features

Simplified parameters and user actions for time-saving procedures.
Traceability IDs: Use the Sepax traceability kit (barcode reader + printer) to track specific identification criteria.
Summary print-out: Print reports at the end of procedures with the Sepax traceability kit (barcode reader + printer).
Main user interface available in: English, French, German, Italian, and Spanish.

Kit / protocol compatibility matrix

Kit / protocol	CS-490.1	CS-470.1	CS-900.2	CS-430.1*
PeriCell	x	–	–	x
SmartRedux	x	–	–	–
ReadyCell	–	x	–	–
NeatCell	–	–	x	–
Adipose	–	–	x	–

*Maximum initial volume limited to 600 mL.

Ordering information

ReadyCell: Product #14302

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post ReadyCell first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

PlasmaFree

Girgin Ltd — Tue, 23 Jan 2018 05:12:55 +0000

Product #14205

PlasmaFree is a protocol designed for routine processing of umbilical cord blood (UCB) to remove only plasma while conserving the nucleated cell component (buffy coat) fraction enriched in hematopoietic stem cells together with the red blood cells. This protocol does not require the addition of any sedimentation agent.

Key features

PlasmaFree features
Initial volume	35 to 440 mL
Selectable final volume	Flexible strategies available
Processing time	~ 20 minutes
Average TNC recovery	90 to 99 % (dependent on initial cell count)

Workflow

Step	Details
1	Prepare a kit with the initial product.
2	Install the kit on the Sepax.
3	The Sepax automatically performs the procedure.
3	Collect the final product.

Product features

User selectable multiple final volume strategies.
Traceability IDs: Use the Sepax traceability kit (barcode reader + printer) to track specific identification criteria.
Summary print-out: Print reports at the end of procedures with the Sepax traceability kit (barcode reader + printer).
Main user interface available in: English, French, German, Italian, and Spanish.

Kit / protocol compatibility matrix

Kit / protocol	CS-570.4	CS-570.1m	CS-570.4mb	CS-570.3m	CS-430.1	CS-470.0
FamCord	x	x	x	x	–	–
PlasmaFree	–	–	–	–	x	x

Ordering information

PlasmaFree: Product #14205

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post PlasmaFree first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

PeriCell

Girgin Ltd — Tue, 23 Jan 2018 05:12:19 +0000

Product #14203

PeriCell is a protocol designed for plasma depletion of apheresis products through a rapid procedure into a selectable final volume of 30-600 mL.

Key features

PeriCell features
Initial volume	100 to 840 mL
Selectable final volume	30 to 600 mL
Processing time	~ 20 minutes
Average TNC recovery	> 90%

Workflow

Step	Details
1	Prepare a kit with initial product.
2	Install the kit on the Sepax.
3	The Sepax automatically performs the procedure.
3	Collect concentrated cells from the final product bag.

Product features

Designed to maximize recovery and minimize processing time.
Traceability IDs: Use the Sepax traceability kit (barcode reader + printer) to track specific identification criteria.
Summary print-out: Print reports at the end of procedures with the Sepax traceability kit (barcode reader + printer).
Main user interface available in: Chinese, English, French, German, Italian, and Spanish.

Kit / protocol compatibility matrix

Kit / protocol	CS-490.1	CS-470.1	CS-900.2	CS-430.1*
PeriCell	x	–	–	x
SmartRedux	x	–	–	–
ReadyCell	–	x	–	–
NeatCell	–	–	x	–
Adipose	–	–	x	–

*Maximum initial volume limited to 600 mL.

Ordering information

PeriCell: Product #14203

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post PeriCell first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

NeatCell

Girgin Ltd — Tue, 23 Jan 2018 05:11:49 +0000

Product #14300

NeatCell is a protocol designed for isolation by means of a density gradient of the mononuclear cell (MNC) fraction from various cellular products into a small final volume of 8-20 mL. Alternatively, a fixed final volume of 45 mL can be chosen. In both cases, optimal granulocyte and Red Blood Cells (RBC) depletion is achieved.

Key features

NeatCell features
Initial volume	30 to 120 mL
Selectable final volume	8 to 20 mL, or 45 mL
Processing time	~1h15 minutes
MNC recovery	> 52%
RBC depletion	> 99%

Workflow

Step	Details
1	Prepare a kit with density gradient medium (via microbial filter), washing solution, and a syringe for collecting the final product (if applicable).
2	Connect initial product to the kit.
3	Install the kit on the Sepax.
4	The Sepax automatically performs the procedure including: • Priming • Isolation via a density gradient medium • Washing
5	Collect purified mononuclear cells from the final product bag or via a syringe.

Product features

Automated procedure comprising of all required steps.
Traceability IDs: Use the Sepax traceability kit (barcode reader + printer) to track specific identification criteria.
Summary print-out: Print reports at the end of procedures with the Sepax traceability kit (barcode reader + printer).
Main user interface available in: Chinese, English, French, German, Italian, and Spanish.

Accessory for small final volume option

Use the separation chamber holder for the last steps of the procedure when collecting the final cells in a pre-connected syringe.

Kit / protocol compatibility matrix

Kit / protocol	CS-490.1	CS-470.1	CS-900.2	CS-430.1*
PeriCell	x	–	–	x
SmartRedux	x	–	–	–
ReadyCell	–	x	–	–
NeatCell	–	–	x	–
Adipose	–	–	x	–

*Maximum initial volume limited to 600 mL.

Ordering information

NeatCell: Product #14300

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post NeatCell first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

FamCord

Girgin Ltd — Tue, 23 Jan 2018 05:11:21 +0000

Product #14310

FamCord is a protocol designed for family blood bank and routine processing of umbilical cord blood (UCB) to isolate the nucleated cell component fraction enriched in hematopoietic stem cells. This protocol allows processing of initial volumes above 30 mL and below 220 mL (anti-coagulant included).

Key features

FamCord features
Initial volume	30 to 220 mL
Selectable final volume	15 to 25 mL
Processing time	20 to 40 minutes
Average TNC recovery	> 80% (dependent on initial volume)

Workflow

Step	Details
1	Prepare a kit with the initial product.
2	Install the kit on the Sepax.
3	The Sepax automatically performs the procedure.
3	Collect the final volume of nucleated cell fraction.

Product features

For mono stopcock (reduced) kits.
User selectable sedimentation profiles.
Traceability: possibility to use the traceability kit of the Sepax (barcode reader + printer) in order to trace specific identification criteria and print a report at the end of each procedure.
Simplified user selectable parameters.
User interface available in English, French, German, Spanish, and Italian.

Kit / protocol compatibility matrix

Kit / protocol	CS-570.4	CS-570.1m	CS-570.4mb	CS-570.3m	CS-430.1	CS-470.0
FamCord	x	x	x	x	–	–
PlasmaFree	–	–	–	–	x	x

Ordering information

FamCord: Product #14310

Packaging: One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post FamCord first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.