TECNICʻO ka hopena no ka hoʻololi ʻana i ka Cell Therapy

Ma ka ʻāina o ka biotechnology, ke hana ʻia nei nā hana nui i ka hanauna e hiki mai ana nā lāʻau lapaʻau a me nā genes (CGTs) ⇀, e hōʻike ana i kahi ala hoʻomaka no nā hana hoʻoponopono i loaʻa ʻole ma mua i nā poʻe maʻi me nā koho therapeutic liʻiliʻi no nā kūlana olakino kūikawā ma o ka hāʻawi ʻana i nā ala pilikino a kuhikuhi ʻia

ʻO kēia ʻenehana hou, i kapa ʻia ʻo ka cell therapy, e kālele ana i ka hoʻokomo ʻana i nā mea ola olakino hou i loko o ke kino me ka pahuhopu o pani i nā mea maʻi a poino paha, modulating the function of the patient’s cells through the expression of factors, or encompassing the removal of dysfunctional cells using immune cells. The potential of cell therapy to halt and reverse diseases, restore damaged organs, and ultimately cure life-threatening conditions is now a realistic goal for scientists who operate at the forefront of regenerative medicine. However, there are immediate and long-term challenges that can be a problem during the manufacturing processes of these medical therapeutics.

Ma ka pane, TECNIC upstream scalable cell expansion bioreactors a downstream ʻO ka hoʻoili ʻana o nā ʻenehana i kahi hana koʻikoʻi i ke kākoʻo ʻana i ka hoʻonui ʻana o ke kelepona, ʻohi, holoi, a me ka noʻonoʻo ʻana, e kōkua mau iā ʻoe e hoʻokō i ka hana i makemake ʻia mai nā unahi o ka ʻimi noiʻi maʻi i ka Pilot and Industrial Bioprocesses ⇀.

He aha ka cell therapy?

From the perspective of life development, diseases in a living body usually indicate problems in the basic unit of its life: cells. In this sense, cell therapy is a broad term that encompasses the hoʻohana a me ka hoʻokaʻawale ʻana o nā ʻano cell like ʻole, maʻamau nā pūnaewele multipotent, ma ke ʻano he lāʻau lapaʻau e hāʻawi ana i nā hopena kupaianaha no nā poʻe maʻi e pono ai nā koho lapaʻau hou. ʻO ka pahuhopu nui o kēia ʻano biotherapy ʻo ka hoʻomohala ʻana i nā huahana lāʻau lapaʻau a me nā hoʻolālā therapeutic i hoʻoponopono a hoʻoulu i ka ʻiʻo a me nā kino i pōʻino a i ʻole, ho'ōla i nā maʻi a me nā kūlana such as lung diseases, neurodegenerative disorders, autoimmune diseases and cancers like adult-onset leukaemia, Hodgkin's lymphoma, or acute myeloblastic leukaemia (AML)

ʻO kahi hiʻohiʻona nui o kāna noi ʻana ʻo ka hoʻohana ʻana i nā cell pluripotent stem cell (iPSC cell) e hāʻawi i kahi kumu kīwī T palena ʻole no ka hoʻomohala ʻana o ka cell T cell therapy, e pili ana i ka hoʻonohonoho hou ʻana i nā T-cell o ka mea maʻi e huli a luku i nā antigens maʻi maʻi. ʻO kēia hui pū ʻana o nā ʻenehana iPSC a me CAR e hāʻawi i kahi manawa kūʻokoʻa i ka oncology a hoʻolalelale nui i ka hoʻomohala ʻana o ka cell-based therapy no nā maʻi maʻi maʻi.

ʻO ka pōmaikaʻi o kēia biotherapy hiki ke loaʻa hoʻopilikino to cure specific individual pathologies. Also, following the principle “Primum non nocere” (first do no harm) and taking into consideration that cellular repair occurs naturally in the human body, cellular therapy is considered to be safe, with no or few adverse effects observed in numerous animal and human preclinical and clinical studies.

ʻO nā lāʻau lapaʻau a me ka ulu ʻana o ka lāʻau lapaʻau pilikino

Ke lāʻau lapaʻau pilikino He ala hou i ka pale ʻana a me ka mālama ʻana i ka maʻi e noʻonoʻo ana i nā ʻokoʻa i ka pane ʻana o kēlā me kēia kanaka i ka lāʻau lapaʻau i mea e hāʻawi ai i "ka lāʻau kūpono i ka nui kūpono i ka manawa kūpono". Ma hope o ka ʻae ʻia ʻana i nā hoʻokolohua lapaʻau, ua alakaʻi mua nā holomua i hana ʻia i ka lāʻau lapaʻau pilikino i nā ʻike hou ikaika a me nā lāʻau lapaʻau i ʻae ʻia i kūpono i nā ʻano kikoʻī o kēlā me kēia kanaka.

I loko o kēia paradigm, allogenic and autologous cell therapies e puka mai ma ke ʻano he ala hoʻohiki:

Autologous cell therapy

Allogenic cell therapy

Hoʻopili ʻia me ka hoʻonui ʻana

ʻO nā pilikia i ka lāʻau lapaʻau

Ke hoʻomohala ʻia nei nā lāʻau lapaʻau kelepona a paʻa i ka ʻōlelo hoʻohiki nui e mālama i ka nui o nā hōʻailona maʻi. Eia nō naʻe, aia nā paʻakikī koke a lōʻihi hoʻi e lanakila ai i mea e hana ai i nā pilikia i ka wā o ka hana ʻana o kēia mau lāʻau lapaʻau:

Nā pilikia hana

ʻO nā pilikia scalability

ʻO ke kumukūʻai o ka hana ʻana i nā pilikia

Nā Bioreactor kiʻekiʻe

I ka pane ʻana i kēia mau pilikia, TECNIC ua hoʻomohala i nā mea hana bioprocess ʻakomi no nā mea ʻelua upstream a downstream ulu ana. Hoʻomaopopo mākou, ʻaʻole e like me ka hana biotech kuʻuna (e like me mAbs a me nā mea olaola ʻē aʻe), ʻo ka hana ʻana a me ka hana ʻana o kēia mau lāʻau lapaʻau pono e mālama ka mea kelepona i nā ʻano koʻikoʻi koʻikoʻi (CQAs) i manaʻo ʻia ke kaʻina holoʻokoʻa.

No ia kumu, TECNIC eLAB® ⇀ , ePILOT® ⇀ a ePROD® ⇀ Hoʻolālā ʻia nā bioreactors e hōʻoia i nā hopena kiʻekiʻe a hiki ke hoʻopuka hou ʻia e lanakila ai i nā pilikia i ʻōlelo ʻia ma mua. Hāʻawi mākou i ka hopena bioprocess maikaʻi loa no nā lāʻau lapaʻau, as our equipment is meticulously designed to provide precise control over environmental parameters, optimizing cellular conditions for maximal yield while minimizing resources and time utilization. Furthermore, our equipment is designed with an automatic unit control that includes integrated data analytics systems, which enables you to fine-tune the culture conditions to develop a smooth bioprocess performance.

Nā Hoʻoponopono Bioreactor Kiʻekiʻe ⇀

ʻO ka kānana ʻo Tangential Flow i ka lāʻau lapaʻau

ʻO ka hapa nui o ka noiʻi a me ka hoʻomohala ʻana i nā bioprocesses o nā cell and gene therapies (CGTs) i kālele i ka hoʻoikaika ʻana o ka upstream Hana. ʻOiai e hoʻomau ka R&D i ka nānā ʻana i ka hoʻomaikaʻi ʻana i ka nui o nā cell a me nā pono hoʻonui kelepona ʻē aʻe, ke hilinaʻi nei ka bottleneck hana i ka downstream hana ʻana. No ka hoʻokō ʻana i kēia pono me ka kikoʻī kiʻekiʻe a me ka throughput kiʻekiʻe, kā mākou eLAB® TFF ⇀, eLAB® TFF SU ⇀, ePILOT® TFF ⇀ a ePROD® TFF ⇀ hāʻawi i kahi hoʻonā hiki ke scaled, automated, fully contained and amenable e hoʻoponopono i nā hana hoʻomohala. Inā ʻoe e hana nei i ka noiʻi paionia a i ʻole ka hoʻokele ʻana i ka hana ʻenehana, hiki iā mākou ke hoʻokō i kāu koi hope e hoʻomohala i kāu mau papahana lapaʻau cell.

E hōʻoia i ka holomua i loko upstream hoʻonui ʻia ka hana ʻana, TECNIC ʻo nā mea hana hoʻi e hōʻoia i ka maikaʻi downstream process development for volume reduction, wash and formulation of the final product. At the same time, the automation of our equipment recipes significantly minimizes the need for manual adjustments, hoʻonui i ka hana o ka mea hoʻohana a hoʻemi i nā koina hana. Eia kekahi, hiki iā mākou ke loaʻa iā ʻoe ka hoʻomaʻemaʻe protein kiʻekiʻe, hoʻihoʻi kiʻekiʻe o nā cell ola me ka liʻiliʻi o ka hopena i kona hiki.

ʻO nā mea hoʻonā hoʻoheheʻe ʻana i ke kahawai ʻo Tangential ⇀

Nā moʻolelo kūleʻa a me nā noi

Hāʻawi ʻia i ka paʻakikī o ka bioprocess, ʻaʻole ia he mea kupanaha ke kumukūʻai kaulana loa o kēia mau biotherapies. In TECNIC makemake mākou e kōkua i kā mākou mea kūʻai aku e hana ʻoi aku ka maʻalahi o ka cell therapy a, no laila, hiki ke loaʻa i nā maʻi. E like me kekahi ʻenehana hou, e iho ana ke kumukūʻai i ka manawa me ka mea hou maikaʻi loa a, ʻoiai ʻaʻole hiki iā mākou ke hāʻawi i nā kikoʻī kikoʻī ma muli o ka hūnā, ua nui nā manawa TECNICUa hoʻonui nui ʻia nā lako hana i ka hana ʻana i kēia mau lāʻau lapaʻau.

With our fully automatic bioreactor eLAB® Advanced and thanks to its multiple configuration (up to 12 fully independent vessels), one of our clients is doing groundbreaking development of autologous cell therapy for replace damaged bone marrow after decorative cancer treatments. Knowing that, as with any form of cell therapy, the end-product quality and quantity depend on the initial population of T cells activated and expanded ex vivo, this specific client had two big important requirements:

Ma muli o ka makemake nui o ka launa pū ʻana, ua hoʻāla ʻia kēlā me kēia maʻi T cell e hoʻomaka i ka hoʻonui ex vivo i koi ʻia mai kahi moʻomeheu bioreactor kū hoʻokahi.

Eia kekahi, no ka maʻi nui o kā lākou mea maʻi maʻamau, ʻo kā lākou T cell ke oʻo maʻamau, ʻokoʻa a hiki ke ʻoki i ka ulu ʻana, no laila pono kā mākou mea kūʻai aku e hiki e hoʻonui i ke kelepona ma nā kūlana moʻomeheu koʻikoʻi.

I mea e hoʻokō ai i kēia mau helu ʻelua, ua paipai mākou i kā mākou mea kūʻai aku i ka eLAB® Advanced ⇀. Thanks to this equipment, designed with versatility in mind, our bioreactor empowered them to development with high precision and control a large range of different T cells cultures of their patients, enabling them to fine-tune their culture conditions using an automatic control unit controlled with an industrial PLC. With it, they were able to have full control over crucial parameters – such as temperature, pH, dissolved oxygen, and agitation speed – of up to 12 fully independent patient cultures simultaneously with reliability and efficiency.

ʻO kēia mea kūʻai aku, ʻike i nā hopena maikaʻi ma mua me TECNIC nā mea hana a me ke kōkua, hoʻoholo e hoʻonui kekahi o kā lākou laina hana mua me nā allogenic therapies, i hana ʻia i loko o nā pūʻulu nui mai nā ʻiʻo hāʻawi pili ʻole e like me ka iwi iwi. I mea e hiki ai i nā maʻi ke loaʻa i ka allogenic cell therapy, pono kā lākou logistics a me nā haʻawina kālā automatic production in cultures of 50 L.

 

Hāʻawi ʻia i ka paʻakikī o ka bioprocess, ʻaʻole ia he mea kupanaha ke kumukūʻai kaulana loa o kēia mau biotherapies. In TECNIC makemake mākou e kōkua i kā mākou mea kūʻai aku e hana ʻoi aku ka maʻalahi o ka cell therapy a, no laila, hiki ke loaʻa i nā maʻi. E like me kekahi ʻenehana hou, e iho ana ke kumukūʻai i ka manawa me ka mea hou maikaʻi loa a, ʻoiai ʻaʻole hiki iā mākou ke hāʻawi i nā kikoʻī kikoʻī ma muli o ka hūnā, ua nui nā manawa TECNICUa hoʻonui nui ʻia nā lako hana i ka hana ʻana i kēia mau lāʻau lapaʻau.

With our fully automatic bioreactor eLAB® Advanced and thanks to its multiple configuration (up to 12 fully independent vessels), one of our clients is doing groundbreaking development of autologous cell therapy for replace damaged bone marrow after decorative cancer treatments. Knowing that, as with any form of cell therapy, the end-product quality and quantity depend on the initial population of T cells activated and expanded ex vivo, this specific client had two big important requirements:

  • Ma muli o ka makemake nui o ka launa pū ʻana, ua hoʻāla ʻia kēlā me kēia maʻi T cell e hoʻomaka i ka hoʻonui ex vivo i koi ʻia mai kahi moʻomeheu bioreactor kū hoʻokahi.
  • Eia kekahi, no ka maʻi nui o kā lākou mea maʻi maʻamau, ʻo kā lākou T cell ke oʻo maʻamau, ʻokoʻa a hiki ke ʻoki i ka ulu ʻana, no laila pono kā mākou mea kūʻai aku e hiki e hoʻonui i ke kelepona ma nā kūlana moʻomeheu koʻikoʻi.

I mea e hoʻokō ai i kēia mau helu ʻelua, ua paipai mākou i kā mākou mea kūʻai aku i ka eLAB® Advanced ⇀. Thanks to this equipment, designed with versatility in mind, our bioreactor empowered them to development with high precision and control a large range of different T cells cultures of their patients, enabling them to fine-tune their culture conditions using an automatic control unit controlled with an industrial PLC. With it, they were able to have full control over crucial parameters – such as temperature, pH, dissolved oxygen, and agitation speed – of up to 12 fully independent patient cultures simultaneously with reliability and efficiency.

ʻO kēia mea kūʻai aku, ʻike i nā hopena maikaʻi ma mua me TECNIC nā mea hana a me ke kōkua, hoʻoholo e hoʻonui kekahi o kā lākou laina hana mua me nā allogenic therapies, i hana ʻia i loko o nā pūʻulu nui mai nā ʻiʻo hāʻawi pili ʻole e like me ka iwi iwi. I mea e hiki ai i nā maʻi ke loaʻa i ka allogenic cell therapy, pono kā lākou logistics a me nā haʻawina kālā automatic production in cultures of 50 L.

 

E ʻimi i kā mākou ʻano lako lako

Hoʻolālā ʻia kā mākou bioreactors no nā noi like ʻole, e hōʻoia ana i ka pono a me ka maikaʻi. E ʻike i kā mākou piha piha o ka biotechnology solutions, me Bioreactors, Tangential Flow Filtration system, a me nā mea hou aku. E kipa i kā mākou ʻaoʻao no Bioreactors ⇀, Hoʻokaʻawale ʻia ke kahe ʻana ⇀, a Hoʻokaʻaʻike ⇀ no ka mea hou information a me na ninau.

ʻO kā mākou mea hana bioprocess kiʻekiʻe ⇀