Swedish companies by ATMP type AstraZeneca Tissue
Description: Swedish companies by ATMP type AstraZeneca Tissue Engineered Products VERIGRAFT Delivery of modified therapeutic cells Therapeutic human protein expressing bacteria Delivery of virus for expression of therapeutic proteins (in vivo GTMP)
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slide1. Swedish companies by ATMP type AstraZeneca Tissue Engineered Products VERIGRAFT Delivery of modified therapeutic cells Therapeutic human protein expressing bacteria Delivery of virus for expression of therapeutic proteins (in vivo GTMP) Delivery of genetically modified cells (ex vivo GTMP) Delivery of in vitro produced mRNAs GTMP sCTMP TEP CellSeed Mendus Xintela Procella Therapeutics Amniotics NextCell Pharma Idogen XNK Therapeutics Anocca Novartis Celgene/BMS AstraZeneca Ilya Pharma CombiGene/Spark Therapeutics CSL Behring Pfizer Lokon Pharma Sarepta/Roche Asgard Therapeutics NEOGAP Sinfonia Biotherapeutics Chiesi Pharma Lipigon Pharmaceuticals Gilead Sciences Sweden/Kite Elicera Therapeutics Elicera Therapeutics Orchard Therapeutics Delivery of pluripotent derived therapeutic cells Cline Scientific Swedish StromaBio Start Materials North X Biologics Takara Bio Amniotics Alder Therapeutics Delivery of synthetic chromosome CarryGenes SeqCure cATMP Encapsulated genetically modified cells Pierre Fabre Pharma AstraZeneca Janssen<br>
slide2. Swedish ATMP service providers QMS plasmid DNA PCR ELISA Microbiology/sterility Analytics/
CRO Manufacture/
CMO Quality Quality Management Stockholm Cellcolabs Mikrolab Tataa Biocenter NorthX Biologics Pluripotent stem cells Takara Bio MSC manufacture Logistics YSDS Logistics Regulatory Affairs NDA group ClinStorage Storage Key2Compliance Key2Compliance Key2Compliance Stability Business AWA Nucleic acid quantification Flow cytometry Truly Labs Truly Labs Patent Pre-clinical Truly Labs Truly Labs Nordic BioAnalysis Nordic BioAnalysis Nordic BioAnalysis Nordic BioAnalysis Container closure Nordic BioAnalysis CMC ProPharma group ProPharma group ProPharma group PEA Olink Tataa Biocenter Micans Bioburden Micans Viscosity Unchained labs LNP quantification and sizing Unchained labs MABTECH Cleanup, formulation, concentration Unchained labs Viral titre/
empty:full ratio/
capsid stability Unchained labs Unchained labs Pharm Assist Pharmacovigilance Pharm Assist Medical Writing Pharm Assist GDP Pharm Assist Production
planning/Management/
automation PlantVision PlantVision Data Integrity PlantVision PlantVision SDS Life Science Clinical SDS Life Science Preparing clinical studies Clinical operations TFS HealthScience CellTherEx CellTherEx Pre-clinical CellTherEx Key2Compliance REFORM society Public Affairs Scaling up clinical trials Cellcolabs ELISpot/
FluoroSpot Ström & Gulliksson Sequencing NorthX Biologics Pyrogen/endotoxin MABTECH Mikrolab Nordic BioAnalysis Micans Strategy and business development MSC Nordics LNP manufacture Biotage<br>
slide3. Swedish ATMP product providers Microcarriers Cell growth Cell sort Freeze CELLINK AcouSort Cellevate Magnetic beads MAGic Bioprocessing 3D BioLamina Growth matrix Bioreactor Cytiva Xuri Miltenyi Biotec Acoustic Antibodies Bags Flow sorter Media 3D printer STEMCELL technologies Cryopreservation media STEMCELL technologies Passage reagent STEMCELL technologies bioMérieux Microbiology/
sterility/
endotoxin Saveen & Werner Start Material Assays LNP Biotage Plasmid DNA NorthX Biologics Takara Bio Pluripotent cells Cellcolabs MSC Bioprocess Cytiva Getinge MABTECH ELISA Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec BioLamina<br>
slide4. Biologics Medicinal Products (2001/83/EC) Medical Devices
(93/42/EEC) Advanced Therapy Medicinal Products (ATMP) (1394/2007) Medical Devices Tissue Therapy Cell Therapy Gene Therapy Biotech Chemicals Type of treatment/product modality By EMA legal classification all gene therapies are GTMPs Combined ATMP
medical device plus a TEP, sCTMP or GTMP Tissue Engineered Product (TEP)
eg. Spherox, lab grown skin for burns treatment, P-TEV (VERIGRAFT) Somatic cell therapy medicinal product (sCTMP)
eg. Holoclar, Alofisel, exp. CD34+, MSC for arthritis, hPSC derived Tissues and Cells (2004/23/EC),
Blood (2002/98/EC) eg. Insulin, antibodies, EV with transgenic protein ATMPs NOT ATMPs eg. Aspirin, Spinraza Synthetic oligonucleotide, legally speaking, are not gene therapies Vaccines eg. DNA vaccines or recombinant virus AGAINST infectious disease eg. medical device only, deceullarised scaffold eg. bone marrow transplant, blood transfusions eg. skin transplant for burns treatment What are ATMPs? (atmpsweden.se) Ex Vivo GTMP
eg. Strimvelis (rec. CD34+), Yescarta (CAR T), emilimogene sigulactibac (rec. bacteria) In Vivo GTMP
eg. Imlygic (onc. Virus), EV with rec. mRNA, rec. trans. mRNA, Zolgenzma (AAV), NTLA-2001 (CRISPR/Cas9) Cell/Gene Therapy Gene Therapy Medicinal Product (GTMP)<br>
slide5. 8 AM 1 PM Tuesday June 27th Morning Wednesday
June 28th 5 PM 1
PM Afternoon Thursday
June 29th 2 PM Filimon Haile
Implementation in public healthcare
Host: Gustaf Befrits 1 PM 2 PM 3 PM 3 PM Stockholm, Sweden (CEST) time Local time for presenter Online atmpsweden.se Sharon Sagnella
Clinical trials in public hospitals
Host: Gisela Helenius Stephan Krause
Quality challenges
Host: Paula Salmikangas Kaz Furuishi
Cell Fiber industrial manufacture
Host: Evren Alici 5 PM 6 PM 12 PM 10 AM 9 AM 6 AM 11 AM Leszek Lisowski
AAV serotype development
Host: Johan Rockberg Setsuko Hashimoto
APACRM reg harmonisation
Host: Axel Ståhlbom EU Life Science conference
(EU Swedish presidency)
Lunch to lunch
Aula Medica
Stockholm, Sweden 6 PM Katherine High
Gene Therapy
Host: Jan Nilsson 9 AM Steve Oh
Industrial adherent manufacture
Host: Ricardo Baptista Monday June 26th ’ATMP world tour’ June 28-30, 2023 4 PM 4 PM 1 PM 2 PM 3 PM 4 PM Morning Friday
June 30th 8 AM 10 AM 9 AM 11 AM 4 PM 5 PM 4 PM 11 AM Steffen Thirstrup
Transforming patient care
Host: Peter Hovstadius Véronique Hédo
Early access model
Host: Fredrik Gerstoft ATMP2030 and ARM co-host a session on needs for EU to be globally competitive in ATMPs Aimei Lee
Clinical trials nurse functions
Host: Jenny Gustafsson Essi Kariaho
Healthcare data - TamroLINK
Host: Pekka Ihalmo<br>
slide7. Get in touch Jim Lund
ATMP 2023 Innovations Milieu
jim.lund@ri.se https://atmpsweden.se/ Heather Main
Project manager ATMP Sweden
heather.main@regionstockholm.se<br>
slide2. Swedish ATMP service providers QMS plasmid DNA PCR ELISA Microbiology/sterility Analytics/
CRO Manufacture/
CMO Quality Quality Management Stockholm Cellcolabs Mikrolab Tataa Biocenter NorthX Biologics Pluripotent stem cells Takara Bio MSC manufacture Logistics YSDS Logistics Regulatory Affairs NDA group ClinStorage Storage Key2Compliance Key2Compliance Key2Compliance Stability Business AWA Nucleic acid quantification Flow cytometry Truly Labs Truly Labs Patent Pre-clinical Truly Labs Truly Labs Nordic BioAnalysis Nordic BioAnalysis Nordic BioAnalysis Nordic BioAnalysis Container closure Nordic BioAnalysis CMC ProPharma group ProPharma group ProPharma group PEA Olink Tataa Biocenter Micans Bioburden Micans Viscosity Unchained labs LNP quantification and sizing Unchained labs MABTECH Cleanup, formulation, concentration Unchained labs Viral titre/
empty:full ratio/
capsid stability Unchained labs Unchained labs Pharm Assist Pharmacovigilance Pharm Assist Medical Writing Pharm Assist GDP Pharm Assist Production
planning/Management/
automation PlantVision PlantVision Data Integrity PlantVision PlantVision SDS Life Science Clinical SDS Life Science Preparing clinical studies Clinical operations TFS HealthScience CellTherEx CellTherEx Pre-clinical CellTherEx Key2Compliance REFORM society Public Affairs Scaling up clinical trials Cellcolabs ELISpot/
FluoroSpot Ström & Gulliksson Sequencing NorthX Biologics Pyrogen/endotoxin MABTECH Mikrolab Nordic BioAnalysis Micans Strategy and business development MSC Nordics LNP manufacture Biotage<br>
slide3. Swedish ATMP product providers Microcarriers Cell growth Cell sort Freeze CELLINK AcouSort Cellevate Magnetic beads MAGic Bioprocessing 3D BioLamina Growth matrix Bioreactor Cytiva Xuri Miltenyi Biotec Acoustic Antibodies Bags Flow sorter Media 3D printer STEMCELL technologies Cryopreservation media STEMCELL technologies Passage reagent STEMCELL technologies bioMérieux Microbiology/
sterility/
endotoxin Saveen & Werner Start Material Assays LNP Biotage Plasmid DNA NorthX Biologics Takara Bio Pluripotent cells Cellcolabs MSC Bioprocess Cytiva Getinge MABTECH ELISA Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec BioLamina<br>
slide4. Biologics Medicinal Products (2001/83/EC) Medical Devices
(93/42/EEC) Advanced Therapy Medicinal Products (ATMP) (1394/2007) Medical Devices Tissue Therapy Cell Therapy Gene Therapy Biotech Chemicals Type of treatment/product modality By EMA legal classification all gene therapies are GTMPs Combined ATMP
medical device plus a TEP, sCTMP or GTMP Tissue Engineered Product (TEP)
eg. Spherox, lab grown skin for burns treatment, P-TEV (VERIGRAFT) Somatic cell therapy medicinal product (sCTMP)
eg. Holoclar, Alofisel, exp. CD34+, MSC for arthritis, hPSC derived Tissues and Cells (2004/23/EC),
Blood (2002/98/EC) eg. Insulin, antibodies, EV with transgenic protein ATMPs NOT ATMPs eg. Aspirin, Spinraza Synthetic oligonucleotide, legally speaking, are not gene therapies Vaccines eg. DNA vaccines or recombinant virus AGAINST infectious disease eg. medical device only, deceullarised scaffold eg. bone marrow transplant, blood transfusions eg. skin transplant for burns treatment What are ATMPs? (atmpsweden.se) Ex Vivo GTMP
eg. Strimvelis (rec. CD34+), Yescarta (CAR T), emilimogene sigulactibac (rec. bacteria) In Vivo GTMP
eg. Imlygic (onc. Virus), EV with rec. mRNA, rec. trans. mRNA, Zolgenzma (AAV), NTLA-2001 (CRISPR/Cas9) Cell/Gene Therapy Gene Therapy Medicinal Product (GTMP)<br>
slide5. 8 AM 1 PM Tuesday June 27th Morning Wednesday
June 28th 5 PM 1
PM Afternoon Thursday
June 29th 2 PM Filimon Haile
Implementation in public healthcare
Host: Gustaf Befrits 1 PM 2 PM 3 PM 3 PM Stockholm, Sweden (CEST) time Local time for presenter Online atmpsweden.se Sharon Sagnella
Clinical trials in public hospitals
Host: Gisela Helenius Stephan Krause
Quality challenges
Host: Paula Salmikangas Kaz Furuishi
Cell Fiber industrial manufacture
Host: Evren Alici 5 PM 6 PM 12 PM 10 AM 9 AM 6 AM 11 AM Leszek Lisowski
AAV serotype development
Host: Johan Rockberg Setsuko Hashimoto
APACRM reg harmonisation
Host: Axel Ståhlbom EU Life Science conference
(EU Swedish presidency)
Lunch to lunch
Aula Medica
Stockholm, Sweden 6 PM Katherine High
Gene Therapy
Host: Jan Nilsson 9 AM Steve Oh
Industrial adherent manufacture
Host: Ricardo Baptista Monday June 26th ’ATMP world tour’ June 28-30, 2023 4 PM 4 PM 1 PM 2 PM 3 PM 4 PM Morning Friday
June 30th 8 AM 10 AM 9 AM 11 AM 4 PM 5 PM 4 PM 11 AM Steffen Thirstrup
Transforming patient care
Host: Peter Hovstadius Véronique Hédo
Early access model
Host: Fredrik Gerstoft ATMP2030 and ARM co-host a session on needs for EU to be globally competitive in ATMPs Aimei Lee
Clinical trials nurse functions
Host: Jenny Gustafsson Essi Kariaho
Healthcare data - TamroLINK
Host: Pekka Ihalmo<br>
slide7. Get in touch Jim Lund
ATMP 2023 Innovations Milieu
jim.lund@ri.se https://atmpsweden.se/ Heather Main
Project manager ATMP Sweden
heather.main@regionstockholm.se<br>