Part Three: Automation is Needed – for scale & safety

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EXPLORING THE POSSIBILITIES OF FLEXIBLE AUTOMATION

See our demonstration of the Signata CT-5 functionality with existing cell and gene therapy tools at the Phacilitate Automation...

SIGNATA CT-5: INCREASING THE PROBABILITY OF SUCCESSFUL CLINICAL OUTCOMES

In this animation, see how the Signata CT-5 allows your skilled workers to be more effective, creating a safe and efficient working environment that increases the probability of positive clinical...

FAST FACTS II WITH BIOINSIGHTS

Our second installment of a three-part series that examines the challenges in cell and gene manufacturing and how to overcome...

IMPROVED COGS WITH nLiven PR

Chimeric Antigen Receptor T cell (carT) Therapies have shown incredible efficacy against multiple hematological cancers. At present, the majority of both commercially available products and those in clinical trials are autologous by nature. Given the inherent...

SEXTON BIOTECHNOLOGIES TO BE ACQUIRED BY BIOLIFE SOLUTIONS

Sexton Biotechnologies, a provider of novel manufacturing solutions for the cell and gene therapy (CGT) industry, today announced that it has entered into a definitive agreement whereby BioLife Solutions (NASDAQ: BLFS) will acquire all outstanding shares of...

FAST FACTS WITH BIOINSIGHTS

Our first installment of a three-part series that examines the challenges in cell and gene manufacturing and how to overcome...

INTRODUCTION TO SIGNATA CT-5

Learn the inspiration behind the creation of the Signata...

SEXTON BIOTECHNOLOGIES AND BIOSPHERIX MEDICAL FOR CELL THERAPY FILL-FINISH

Sexton and Biospherix have developed a system ready for deployment to meet fill finish needs of the cell therapy...

HOW TO USE CELLSEAL VIALS

Instructional video for the use of CellSeal...

CELLSEAL ADAPTER ACCESS

See the functionality of the CellSeal Vial...

SIGNATA CT-5 CAD ANIMATION

See the flexibility in fill processes and multiple functionality of our automated fluid management...

SIGNATA CT-5 PROTOCOL SET-UP

How to set up a new fill protocol using the Signata CT-5...

SEXTON PANEL DISCUSSION AT CAR T GLOBAL WEEK

Advancements in Manufacturing, GMP and Global Supply Chain...

INSTALLING CT-5 TUBE SETS

Set up and installation of CT-5 tube sets raises the bar for simple and intuitive closed system fluid management. Ready to use in less than two...

FILL-RINSE-FORMULATE-STORE WITH SIGNATA CT-5

Control for fluid management has never been easier for Cell and Gene Therapy manufacturing. The Signata CT-5 allows closed connections to multiple unit operations from filling bioreactors to final...

SIGNATA CT-5 WITH CELLEXUS CELLMAKER

Signata CT-5 provides exceptional versatility in cell and gene therapy manufacturing. In this video we work with MED Institute to use the Cellexus CelMaker bioreactor with the CT-5....

BIODEFINED MEDIA: A NEW CATEGORY OF BIOLOGICAL SUPPLEMENTATION

Watch this webinar to learn more about how Sexton's platelet lysate provide reduced variability in growth...

SIGNATA CT-5 SIMPLIFYING CLOSED FLUID MANAGEMENT

Watch our first animation in a series discussing how the Signata CT-5 can close fluid handling processes in your lab while maintaining...

SEXTON BIOTECHNOLOGIES, HITECH HEALTH, AND MED INSTITUTE ANNOUNCE COLLABORATION TO DEMONSTATE THE BENEFITS OF FLEXIBLE AUTOMATION

Their collaboration will develop and publish workflows for integrating unit operations in cell therapy manufacturing using flexible automation...

VIAL ADAPTER PRODUCT INSTRUCTIONS

Product instructions for CellSeal Vial Adapter....

CELLSEAL CLEAR ACCESS USER GUIDE

User guide for CellSeal Clear Access...

hPL (STEMULATE) AND PRhPL (nLiven PR & T-LIVEN PR) PRODUCT INSTRUCTIONS

Product instructions for human platelet lysate (hPL) products....

hPL (STEMULATE) AND PRhPL (nLiven PR & T-LIVEN PR) SAFETY DATA SHEET (SDS)

Safety Data Sheet for Sexton human platelet lysate (hPL) products....

EU APPROVAL OF MESENCHYMAL STROMAL CELL THERAPY MANUFACTURING PROTOCOL USING nLiven HUMAN PLATELET LYSATE FOR A PHASE 1B CLINICAL TRIAL

Sexton Biotechnologies and CCMI Galway collaborative effort leads to approval by EU regulatory authorities for the use of nLiven PR in the expansion of an allogeneic MSC therapeutic product to address corneal transplant...

ISO CERTIFICATE

Holds certificate number FM631912 and operates a Quality Management System which complies with the requirements of ISO 9001:2015 for the following scope......

SEXTON BIOTECHNOLOGIES PARTNERS WITH BIOSPHERIX TO CREATE A FULLY-ENCLOSED, MODULAR FILL-FINISH SYSTEM WITH RAPID DEPLOYMENT FOR EMERGING CELL AND GENE THERAPY NEEDS

Sexton Biotechnologies has announced a new collaboration with BioSpherix Medical. As a tool and technologies partners of the Cell and Gene industry, Sexton and BioSpherix both recognize the need for cost-effective and flexible automation solutions during cell...

SEXTON BIOTECHNOLOGIES RELEASES FLEXIBLE AUTOMATION FILLING SYSTEM – SIGNATA CT-5

Sexton Biotechnologies looks to bring downstream automation for small-to-mid sized manufacturing companies to increase efficiency and...

SIGNATA CT-5 BROCHURE

Learn how our flexible automation fill and finish system can enhance your lab processes....

SEXTON BIOTECHNOLOGIES AND IKEDA SCIENTIFIC PROVIDE HUMAN PLATELET LYSATE TO JAPANESE REGENERATIVE MEDICINE PRODUCT MANUFACTURERS

Sexton Biotechnologies pathogen reduced hPL confirmed by PMDA as human derived raw material for regen med...

OPTIMIZING MSC PRODUCTION

Manufacturing of cell therapies is a time consuming and expensive proposition. Optimizing manufacturing processes involves establishing culture parameters to reduce time and expense while providing a phenotype that delivers the intended efficacy. One of the more critical elements of cell manufacturing remains the growth supplements required for optimal growth. Traditionally, fetal bovine serum (FBS) has been the work-horse of cell culture. Alternatively, human derived supplements from processed blood have been growing in usage across the field....

STRATEGIES FOR MSC EXPANSION AND MICROTISSUE FOR BONE REGENERATION (BUNPETCH ET AL)

Review and discussion of the optimization of MSC and microtissue expansion for bone regeneration in clinical applications....

PEAK SERUM: IMPLICATIONS OF SERUM SUPPLY FOR CELL THERAPY MANUFACTURING (BRINDLEY ET AL)

Commentary on the state of serum supply and demand in the cellular therapy industry....

HUMAN DERIVED ALTERNATIVES TO FBS (WITZENEDER ET AL)

Comparative analysis of hPL, human serum, and FBS showing hPL and human serum can be used as alternatives to FBS for the cultivation and expansion of MSCs....

hPL EXPANSION OF PERIPHERAL BLOOD DERIVED ENDOTHELIAL CFCS (TASEV ET AL)

Isolation and expansion of PB-ECFCs in hPL permits suitable large-scale expansion for therapeutic use....

PATHOGEN-FREE PLATELET LYSATE AND EXPANSION OF MSCS (IUDICONE ET AL)

Pathogen Inactivated hPL is shown to be a good candidate to replace FBS in a clinical scale culture system....

CRYOPRESERVED VS. REFRIGERATED LYOPHILIZED hPL FOR WOUND HEALING (NOTODIHARDJO ET AL)

Both refrigerated and cryopreserved lyophilized hPL showed similar levels of growth factors while promoting wound healing in mice....

PLATELET LYSATE FOR THE CULTURE OF EQUINE BM-MSCS (NASKOU ET AL)

Equine platelet lysate has the potential to be used for the expansion of MSCs for clinical application while avoiding the concerns associated with FBS....

NANOCALCIUM SULFATE AND hPL AS A GROWTH FACTOR DELIVERY SYSTEM (BARONE ET AL)

Results support the emerging potential for the development of functional scaffold/growth factor delivery systems that could be used in the treatment of craniofacial bone defects....

hPLS PROMOTE MSC EXPANSION: A SAFETY SUBSTITUTE FOR ANIMAL SERUM (DOUCET ET AL)

Compared to FBS, hPL was able to demonstrate increased MSC proliferation while maintaining differentiation and immunosuppressive activity....

ANALYSIS OF INDUSTRIAL SCALE hPL PREPARATIONS (PIERCE ET AL)

Comparative analysis shows use of a large-scale, standardized method results in hPL with performance as good as or better than FBS....

CHOICE OF XENO FREE MEDIA AND ITS INFLUENCE ON DIFFERENTIATION (BRUN ET AL)

Addition of hPL to media preparations increases proliferation of MSCs and their differentiation potential....

PRODUCTION OF hPL USING ULTRASOUND SONICATION (BERNARDI ET AL)

Sonication of platelets has shown to be a safe, efficient method for hPL production for use in ex vivo expansion of BM-MSCs....

SCALABLE EXPANSION OF MSCS IN XENO FREE MEDIA (RIORDAN ET AL)

Data supports hPL supplemented media as an alternative to FCS which may lead to safer MSC products for therapeutic uses....

DIFFERENTIATION OF PSCS INTO MSCS USING hPL (LUZZANI ET AL)

hPL is shown to generate significantly more MSCs than FBS with use of a lower cost, clinically applicable protocol....

FIBRINOGEN DEPLETED hPL AND FUNCTIONALITY OF MSCS IN IMMUNOTHERAPY (COPLAND ET AL)

Fibrinogen depleted hPL shows lower interference with immunomodulatory functions of MSCs compared to a non-depleted hPL....

hPL AS A SUITABLE REPLACEMENT FOR FBS IN MSC CULTURES (MOJICA-HENSHAW ET AL)

Human MSCs cultured with hPL yielded higher proliferation with similar surface markers/differentiation when compared to FBS....

hPL VS. FBS: ISOLATION METHODS OF HUMAN UC-MSCS (KANDOI ET AL)

MSC yield and immunomodulatory activity shows a 2-fold increase with hPL supplementation when compared to FBS....

SCALABLE PRODUCTION OF MSCS UNDER XENO-FREE CONDITIONS (RITA MARGARIDA DE SOUSA COSTA)

Results demonstrate the feasibility to optimize a xeno-free, hPL culture system for hMSC cultivation....

GROWTH AND OSTEOGENIC DIFFERENTIATION OF MSCS USING hPL (JONSDOTTIR-BUCH ET AL)

Findings suggest that hPL can be used as an alternative to FBS for MSC with no inherent difference between use of fresh or expired platelet units....

hPL AS A XENO FREE ALTERNATIVE TO FBS FOR EXPANSION OF MSCS (MOHAMMADI ET AL)

hPL shown to be a safe alternative source of growth factors for expansion of MSCs while maintaining similar growth potential and phenotype....

MECHANICAL FIBRINOGEN-DEPLETION FOR PRODUCTION OF hPL (LANER-PLAMBERGER ET AL)

Mechanical fibrinogen-depletion offers an efficient, reproducible, and economical method for the preparation of hPL used in the expansion of MSCs....

MSCS EXPANDED IN hPL DISPLAY DECREASED INHIBITORY CAPACITY ON IMMUNE CELLS (ABDELRAZIK ET AL)

Data shows that MSCs cultured in hPL demonstrate a decreased inhibitory capacity on T cell and NK cell proliferation and function....

hPL VS. PRP VS. FCS: EFFECTS ON MSCS (LYKOV ET AL)

A real-time study showed that platelet-rich plasma produces the most potent stimulatory effect, while both platelet-rich plasma and platelet lysate stimulated migration of cells....

PRODUCTION METHODS AND THEIR EFFECT ON PLATELET DERIVATIVES’ ABILITY TO EXPAND MSCS (BERNARDI ET AL)

hPL produced using CaCl2 activation of platelets yields higher concentrations of growth factors, as well as higher rates of expansion, when compared to hPL produce using a repeated freeze/thaw method....

MSC EXPANSION USING hPL PER A GMP GRADE PROTOCOL (BECHERUCCI ET AL)

Concludes that hPL can be considered a safe alternative to FBS for expansion of MSCs without affecting MSC immunophenotype, immunomodulatory potential, differentiation potential and relative telomere length...

USE OF hPL FOR PROPAGATION OF WHARTON’S JELLY MSCS (CHEN ET AL)

Data shows Wharton's Jelly MSCs expanded equally well, exhibited a typical fibroblast morphology, had short doubling times, maintained their immunophenotypes, and differentiated into chondrocyte, osteocyte, and adipocyte lineages in hPL-supplemented media....

hPL AS AN ALTERNATIVE TO FBS FOR LARGE-SCALE BM-MSC EXPANSION (GOTTIPAMULA ET AL)

BM-MSCs cultured in hPL had significantly higher immunosuppression compared to FBS, illustrating hPL as a sufficient alternative to FBS....

EVALUATION OF GMP COMPLIANT CELL CULTURE MEDIA (WUCHTER ET AL)

Comparison study of two commercially available hPL serums to determine efficiency and optimization potential....

ANIMAL SERUM-FREE CULTURE METHODS FOR BM-MSCS (LAITINEN ET AL)

Presented are robust and reproducible culture methods for BM-MSCs based on hPL, enabling an animal-free and large scale culture option....

PLATELET LYSATE OUTPERFORMS FCS AND HUMAN SERUM IN CULTURE OF HMSCS AND MACROPHAGES (TYLEK ET AL)

hPL is shown to maintain the phenotype and activity of both hMSCs and human macrophages compared to FCS and human serum. ...

PLATELET DERIVED BIOMATERIALS FOR THERAPEUTIC USE (ARORA ET AL)

Technical review of the evolution and types of platelet biomaterials available for clinical use....

PLATELET LYSATE RETAINS DIFFERENTIATION CAPABILITIES OF UMBILICAL VEIN ENDOTHELIAL CELLS (ROMALDINI ET AL)

Offers data to suggest a possible in vivo contribution of hPL to new vessel formation by activation of cells resident in wounded vessel walls....

PLATELET LYSATE-HYALURONIC ACID HYDROGEL FOR THE SUPPORT AND CHONDROGENESIS OF MSCS (JOOYBAR ET AL)

Platelet lysate is shown to have a vital role in supporting hMSCs activities, like cell attachment, viability and proliferation as well as induce cartilage generation in a 3D hydrogel....

UV LIGHT IRRADIATION OF hPL PLATELETS AS A VIABLE OPTION FOR PATHOGEN REDUCTION (VIAU ET AL)

UV light treated platelets used in the manufacture of hPL were able to show pathogen reduction while preserving quality and efficacy of the product....

CHARACTERIZATION OF hPL FOR EXPANSION OF BM-MSCS (VIAU ET AL)

Demonstration of the feasibility to use a standardized, efficient, and clinical grade hPL for research and cell therapy applications. ...

hPL BASED CULTURE PRESENTS SCALABLE PLATFORM FOR UC-MSCS ISOLATION AND EXPANSION (DE SOURE ET AL)

The present paper reports the establishment of an easily scalable integrated culture platform based on a human platelet lysate supplement for the effective isolation and expansion of UC-MSCs in a xenogeneic‐free microcarrier‐based system....

STEMULATE PRESERVES VIABILITY OF VARIOUS STEM CELLS DURING CRYOPRESERVATION (TAYLOR ET AL)

Stemulate based cryopreservation is shown to maintain high viability of adult and neonatal stem cells and primary cells post thaw....

STEMULATE SUPPORTS DIFFERENTIATION OF IPS CELL-DERIVED ENDOTHELIAL CFUS (SHELLEY ET AL)

Poster showing how Stemulate is an alternative to FBS for culture of endothelial CFUs derived from human PSCs using a directed differentiation approach....

PHENOTYPIC CHARACTERIZATION OF hPL EXPANDED MSCS VIA FLOW CYTOMETRY (REIS ET AL)

A look into differential cell surface protein expression between MSCs grown in hPL vs. FBS....

hPL VS. HPS VS. FBS: CORNEAL EPITHELIOTROPHIC ABILITIES (HUANG ET AL)

Comparative study of human platelet lysate, human peripheral serum, and FBS detailing how hPL showed comparable epitheliotrophic abilities and wound healing rates compared to hPS and FBS (in vivo and ex vivo)....

CHONDROGENIC EFFECT OF CANINE PLATELET LYSATE ON CANINE ADMSCS (LIMA ET AL)

Canine platelet lysate is shown to result in higher proliferation rates and induction of chondrogenic differentiation of canine ADMSCs when compared to FBS....

hPL SUPPORTS MSC PROLIFERATION AND CHROMOSOMAL STABILITY (CRESPO-DIAZ ET AL)

Study detailing how GMP-grade hPL shows to be a reliable source for BM-MSC and ADSC proliferation, compared to FBS, while protecting against chromosomal aberrancy....

hPL IS A FEASIBLE CANDIDATE TO REPLACE FCS (HOFBAUER ET AL)

Research shows that use of hPL on blood vascular and lymphatic endothelial cells did not reveal any substantial negative effects when compared to FCS....

MARKET ASSESSMENT OF PORCINE PLATELET LYSATE FOR ANIMAL CELL CULTURE (STALHOS ET AL)

Evidence shows there is a willingness in the research community to test porcine platelet lysate with the condition of a competitive price range compared to FBS and serum free medias....

SILK FIBROIN FIBERS FOR STORAGE AND RELEASE OF hPL (PIGNATELLI ET AL)

Analyzing the effects of enclosing hPL in a silk fibroin electrospun matrix to expand its utilization in wound healing....

hPL DONOR AGE AND ITS EFFECTS ON MSC PROLIFERATION AND DIFFERENTIATION (LOHMANN ET AL)

Study investigating how age of donors for platelet units used in the manufacture of hPL effects the proliferation and differentiation potential of BM-MSCs....

PLATELET MICRORNA-MRNA COEXPRESSION AND PLATELET ACTIVITY (NAGALLA ET AL)

Research into how platelet miRNA effects platelet proteins and platelet reactivity as well as how bioinformatic approaches can successfully identify functional miRNAs in platelets....

hPL AND MINOXIDIL FOR TREATMENT OF HAIR LOSS (DASTAN ET AL)

Research shows that hPL mixed with minoxidil can promote hair growth by activating the main anagen inducing signaling pathways....

PATHOGEN INACTIVATION AND ITS ROLE IN SAFEGUARDING THE SAFETY OF BLOOD TRANSFUSION (CHEN ET AL)

In addition to donor screening, pathogen inactivation has become one of the most important steps to ensure the safety of blood units for transfusion....

GAMMA IRRADIATION AS A METHOD FOR VIRAL INACTIVATION OF hPL (VIAU ET AL)

Viral inactivation of hPL by gamma irradiation is shown to preserve its optimal efficiency in the expansion of BM-MSCs....

DOUBLE VIRAL INACTIVATED hPL FOR EXPANSION OF MSCS (BARRO ET AL)

Findings reinforce the potential of virally inactived hPL as a safe alternative to FBS, or untreated hPL, for clinical grade MSC expansion...

HUMAN BLOOD PLATELET LYSATE SUPPLEMENTS FOR EX VIVO STEM CELL EXPANSION (SHIH ET AL)

A look into how preparation, quality criteria, and properties of hPLs such as Stemulate and nLiven PR can become the future "gold standard" supplement for ex vivo production of MSCs for clinical use....

BIOMOLECULAR CONSEQUENCES OF PLATELET PATHOGEN INACTIVATION METHODS (FEYES ET AL)

A review of biomolecular effects of pathogen inactivation treatments on platelets, and how it can help blood banks and transfusion specialists guide their choice in clinical use of PI treated platelets....

FBS: PAST – PRESENT – FUTURE (VALK ET AL)

Article detailing the background of FBS and how alternative serums and chemically defined medias are the ultimate goal for the majority of culture systems....

AN INTRODUCTION TO SERUM REPLACEMENTS AND SERUM FREE MEDIA (KARNIELI ET AL)

Due to a growing need and dwindling supply, there is a strong push for FBS replacements. This paper reviews the available serum replacements and strategies for replacement....

A CONTEMPORARY VIEW OF PLATELET RICH PLASMA THERAPIES (ANDIA ET AL)

A look into how serious diseases may benefit from PRP therapies in combination with cell products....

HUMAN PLATELET LYSATE: CURRENT STANDARDS AND FUTURE DEVELOPMENTS (HENSCHLER ET AL)

Report on the workshop organized by the Working Party on Cellular Therapies of the International Society of Blood Transfusion (ISBT) looking into the current standards surrounding hPL products and regulatory considerations in the field....

STEMULATE’S EFFECT ON STAGES OF SYNOVIAL MSC ACTIVITY (ALTAIE ET AL)

A study into how hPL serum such as Stemulate effects the adhesion, proliferation, migration, and chondrogenic differentiation of synovial MSCs....

IMPACT OF hPL ON EXPANSION AND CHONDROGENIC CAPACITY FOR CARTILAGE CELL THERAPY (SYKES ET AL)

A look into how Stemulate influences chondrocyte proliferation and differentiation potential....

CHARACTERIZATION OF nLiven PR (CHARLEBOIS ET AL)

E-Beam radiation shown to yield a pathogen reduced hPL product that is consistent, preserves cell growth functionality, and reduces risk of viral transmission....

T-LIVEN PR AS A SUCCESSFUL ALTERNATIVE FOR EXPANSION OF IMMUNE CELLS (CANESTRARI ET AL)

Human platelet lysate is show as a successful alternative to FBS and human AB serum to effectively propagate primary human lymphocytes....

SCALABLE PRODUCTION OF HUMAN MSCS IN A BIOREACTOR SYSTEM USING STEMULATE (MEIRING ET AL)

Results show that a bioreactor system using Stemulate has the potential for large scale expansion of hMSCs for clinical use....

BM-MSCS EXPANDED IN hPL VS. FBS (STENGER ET AL)

In pediatric patients with Sickle Cell Disease, BM-MSCs can be expanded ex vivo in hPL in a clinically relevant timeframe....

STEMULATE AND ITS ROLE IN THE CRYOPRESERVATION OF MSCS (WOODS ET AL)

Stemulate provides an animal component free option for cryopreservation media, with less risk and regulatory challenges as animal derived components. Stemulate was shown to improve cell recovery and functionality following thaw....

DEVELOPMENT OF LARGE-SCALE ADSC MANUFACTURING USING BIOREACTORS AND STEMULATE (HAACK-SøRENSEN ET AL)

The use of Stemulate as a growth supplement for ADSC expansion in the quantum cell expansion system provides an efficient expansion process compared to the use of FBS, while maintaining cell quality appropriate for clinical use....

SILK SERICIN AND PLATELET LYSATE FOR THE FORMULATION OF WOUND HEALING MEDICATIONS (BARI ET AL)

In clinical practice, both silk sericin and platelet lysate were employed for various reparative treatments and showed to sustain the wound repair process regulating fibroblast recruitment, migration, proliferation and differentiation. ...

POOLED HUMAN SERUM: A NEW CULTURE SUPPLEMENT FOR BIOREACTOR-BASED CELL THERAPIES (SAVELLI ET AL)

Study investigating the efficacy of pooled human serum to provide clinically relevant numbers of MSCs and MPCs for regenerative medicine applications through use of the Quantum System....

STEMULATE ENHANCES SYNOVIAL FLUID MSC FUNCTION (ALTAIE ET AL)

Study provides biological support that Stemulate may be capable of modulating multiple functional aspects of joint resident MSCs with direct access to injured cartilage....

MODULATION OF MINERALIZATION BY MSCS BASED ON hPL PREPARATIONS (BORALDI ET AL)

Data demonstrates that hPL variously influences mineral deposition depending on cell line and possibly on platelet product preparation methods....

METHYLCELLULOSE AS A SCAFFOLD FOR THE POTENTIAL OF TREATING ACUTE LIVER FAILURE (CHANDRASHEKRAN ET AL)

A look into methylcellulose as a scaffold in the culture of liver-organoids, with the aid of Stemulate cultured MSCs, for the potential of treating acute liver failure....