Merck Life Sciences

merck milliporesigma formulation regulatory bioprocessing next generation bioprocessing biopharmaceutical manufacturing single-use downstream processing biopharmaceuticals process development- biomanufacturing continuous bioprocessing tangential flow filtration monoclonal antibody gene therapy cell culture media clarification cell culture webinar bioreactor cell line development biosafety chromatography upstream processing cell & gene therapy biomanufacturing pharmaceutical final fill regulatory guidelines sterile filtration purification solid formulation biosafety testing single-use systems next generation processing viral clearance bioreliance excipients risk assessment process intensification clarification/harvest antibody drug conjugate contract dev & mfg vaccines mabs process mabs cell therapies risk mitigation vaccine manufacturing patient safety virus removal adcs active pharmaceutical ingredient regulatory requirements viral safety diafiltration chromatography purification aav viral contamination ultrafiltration sterilization harvest biosafety services ultrafiltration/diafiltration & concentration drug development cell and gene therapy adeno-associated viruses (aav) adeno-associated virus chozn raw materials product characterization biologics safety case study buffer & media prep viral vector manufacturing sterile sampling adc chromatography resins virus detection scale up tff vaccine processing chemistry manufacturing healthcare pharmacetuical process development extractables and leachables cell line perfusion virus api conjugation viscosity reducing excipients e2e mrna vaccines mab viral vector cell therapy large scale cell culture biotherapeutic formulation single use upstream process biosimilars bioprocess development high concentration protein formulations intradermal injection intravenous to subcutaneous iv to sc solubility enhancement iv to subq protein viscosity contract manufacturing viscosity reducing additives biotechnology cmo sterilizing grade filters seed train cell culture seed train risk management adventitious virus contamination chozn gs-/- expression system novel therapies process validation lentivirus training education and training bioburden qbd validation sterile filtration & bioburden control next-gen processing tech transfer research perfusion media plasma continuous manufacturing collaboration monoclonal antibodies sptff viscosity reducing agents bioburden control covid-19 regulatory/validation viscosity reduction platform single-pass tff downstream mrna quality by design protein stability automation pupsit single-use technology downstream purification solid dose virus inactivation operator safety human mesenchymal stromal stem cells pharma cgmp virus prevention bpog extractables cell bank toxicology molecule clinical development vlp usp <665> liquid formulation bioavailability continuous processing life science aseptic filter innovation filtration cell line characterization amorphous formulation single-use bioreactors regulatory affairs / validation gene therapy manufacturing host cell protein sterilizing filtration api synthesis chromatography/purification fluid management drug delivery therapeutic protein formulations reformulating protein biotherapeutics intramuscular injection intravenous injection subcutaneous formulation development mesoporous silica technology mesoporous silica formulations mesoporous silica lot release testing regulatory documentation in vitro solid dosage activated pegs replication competent virus flow-through polishing depth filtration anion exchange chromatography peg final sterile filtration excipient pva drug release advanced drug delivery gmp-compliant biotech process emerging biotech mab development filter integrity testing aav therapy normal flow filtration viral product manufacturing bioburden reduction emprove® api chemical synthesis provantage biodevt & e2e services integrity testing microfiltration api stability pdadmac solid dosage drug formulation emprove biologics recombinant protein semi-solid formulation data visualization & analysis gene editing nanoparticulate impurities mass spectrometry tupps cation exchange chromatography hot melt extrusion polyvinyl alcohol concentration a&f filter mrna manufacturing process chromatpgraphy protein a membrane membrane chromatography natrix mscs bioprocess orchestration software zika pcr cho lipids plasmid dna pdna lipid nanoparticles 3d printing technology automation system supply chain upstream and downstream processing viral therapies 3d printing draft annex 1 ich q10 facility of the future innovative technologies in biomolecule formulation buffer hmscs biocontinuum clean rooms adc therapies stainless steel car-t chetosensartm maycoretm dolcoretm sterile filtration / prefiltration viral & gene (vgt) therapy manufacturing josephine cheng protein purification continuous process protein aggregation virus safety dsp platform vgt lipid based rna viscosity reducing excipient excipient risk assessment process development protein viscosity on syringeability ccm active and formulation bacterial fermentation cld biologic drugs oral solid dosage purification template cpv types of oral dosage form tablets dosage forms continued process verification regulatory compliant solid pharmaceutical dosage form map/hap horizon2020 types of oral solid dosage forms bioprocess international titer disposable technology continuous chromatography neotame analytical development biosimilar mab oral solid process scalability kla glycosylation pharmaceutical solid dosage forms n-glycan profiling of monoclonal antibodies oral solid dosage manufacturing big data potency gmp manufacturing solid dosage forms mitigating risks single-pass tengential flow filtration facility intensification solid dosage forms include phenylketonuria oral solid dosage forms single-pass buffer delivery solid dosage formulation collaborative forecasting solid dose pharmaceuticals prefilter forecast supply robustness process monitoring biologics manufacturing risk of cross-contamination efficiency in media preparation compaction of cell culture media and single chemic buffer concentrates footprint saving buffer management cell lines biopharmaceutical small scale cell culture media and supplements industry 4.0 eu gmp annex 1 draft biopharm ingredients bevs adcore product line cell & gene therapy (cgt) services sterile medicinal products eu commision falsified medicine directive chinese regulation pei biotherapy assays regulations process impurities intensified mab purification preclinical stage clone selection post approval changes biopharma training apac emerging markets integrity testers sf-rvn api registration baculovirus expression vector formulation of tablet dosage form virus spiking activated polyethylene glycols complex injectables polyethylene glycols viscous formulations liphophilic payload pk/pd nanoparticles monodisperse oral dosage forms linkers liposomes multi-use systems hardware adc payloads single-use assemblies hydrophilicity platform assay platform manufacturing adc express™ solubility slc single-use connectors scale-up performant rhabdovirus-free dosage form of tablet formula sf9 rhabdovirus-negative gmp cell banking clinical trial extractables risk assessment leachables risk assessment pharma raw material risk viral risk biophorum regulatory expectations actives and dormulation process sampling novaseptum adcc cdc equipment qualification genotoxicity serum free media fetal bovine serum sac sars-cov-2 spike protein api solubility salt formation bioassays therapeutic medicine gene therapies gmp qc testing audit funding corporate funding startup audits venture capital technology alison armstrong final fill vial virtual technology remote remote audit remote technology extractables data filtration technology pharmaceutical risk management protein a cation exchange ethylene glycol cip cleaning in place naoh eshmuno eshmuno a protein a column cleaning efficiency increase lifetime resin performance media prep parteck ta calcium carbonate titanium dioxide tio2 titanium dioxide alternative tio2 alternative tablet coating tablet coating polyvinyl viral contamincation cocrystal formation api processing small-molecule api surfactants drypour mobius protein solutions adventitious virus agitation stress ex-cell advanced particle formation ucoe expression vectors protein stabilization shear protection bioprocess performance loss lot-to-lot variation poloxamer 188 pluronic-f68 polymer based drug delivery systems polymer based parenteral controlled-release drug d x-ray virus like particle vaccine collaboration cov-2 vaccines sars-cov-2 vaccine innovative biotech technovax west african pandemic bio4c biodevelopment bioprocess orchestration softw process orchestrator synthetic lipids product quality testing considerations operational efficiency process orchestration microcarrier process automation sucralose high intensity sweeteners bioprocesing rca rca assay intravenous immunoglobulin ivig purification rca testing adenoviral vectors process optimization x-ray sterilization drug approval accelerate product certification pasteurization viral risk mitigation htst small molecule series smallmoleculeseries pla/plga polymersmall molecules optimum polymer technologyformulation technologies appropriate quality bioreliance services martin wisher european pharmacopoeia fda agent contamination 3d virus seed polymers business development melt based melt based 3d large scale manufacturing zfn identity testing risk solvent viral gene therapy ngs assays ngs excipient impact synbiosys® multi-block polymer introductionparente virus testing q5a ich q5a ekko™ acoustic cell processing syste philipp buehle 2d data matrix barcode 2d barcode barcode drug manufacturer raw materials supplier digital innovation biotech events science car-t manufacturing dmso ekko™ select system t cell douglas bowman coating process coating dashboard data center saas software and automation software development software closed processing single-use tff hc agnostic hcp id hcp host cell protein impurities biotherapy purity host cell proteins powder feeding cm electrostatic charge crazy powder (qc) test methods e&l process validation strategy regulatory considerations risk-based approach technology transfer cdmo end to end capsid protein cqa critical quality attributes orthogonal method orthogonal methods technically unavoidable particle profiles emprove® chemicals emprove® lsm laser scanning microscopy optical coherence technology coating formulation development oct particle designed pva mobius® single-use bioreactors templated manufacturing process suspension-based lentivirus production bioreactor process scalable upstream bioreactor process scalability lentiviral vector production virus bank services filament-based hot melt extrusion process pharmaceutical industry pharmaceutical manufacturing pharmaceutical dosage pharmaceutical dosage forms additive manufacturing formulation development perfusion technologies perfusate viral contaminant cell banks bio4c™ processpad data management software mycoplasma methods for sterility quality control testing test methods compen-dial proteins peptides injectables sterility assurance recombinant production virus filters roller compaction granulated material raw material handling dry granulation caking and clumping manufacturing efficiency flocculation protein a resin scale-up development virusexpress™ lentiviral production platform speed up high-potent payloads leo ohrem solid dose formulation xiaolong sun jerome dalin trends in vaccine manufacturing quality management systems qmss pharma grade sugar excipient(s) polyol(s) low npi sucrose bulking agent biomolecules pharma(ceutical) grade sucrose sucrose pharmaceutical excipient stabilize biomolecules syringability filter performance subcutaneous administration subq paul genest filter virus removal optimize filter virus removal filter capacity parvovirus filtration product safety stability testing edmund ang janice tan chozn expression platform cd cloning media subsequent bioprocess chemistry manufacturing controls cmc chemically defined cloning media production cell line upstream process develoment dolastin giuseppe camporeale ashok kumar payload intermediate linker-payload fc-fusion protein chozn-gs system chozn gs chozn-gs bacterial retention testing validation services eu gmp annex 1 vaccine technologies vaccine development and manufacturing vaccine development novel vaccine development human therapy stemline® bone marrow ex vivo cell expansion media formulation human mesenchymal stromal/stem cells mesenchymal stem cell growth mesenchymal xeno free culture high yields reduce viscosity synergistic effects formation thierry burnouf subcutaneous igg infusion scalable plasma process aseptic filtration removal of detergent removal of solvent virus inactivation steps affinity chromatography flow-through-mode chromatography fractionation flow safety and quality of plasma igg plasma immunoglobulin purification plasma igg purification process flow-through purification mab production recombinant development fc-fusion viral genome viral capsids liquid dosage form auc assay tableting sustained release active pharmaceutical ingredients fast track approach • data visualization • cpv • continued process verification • laboratory information management system (lims) • manufacturing execution system (mes) • enterprise resource planning (erp) • biopharmaceutical processes • data management • next-generation bioprocessing • software analytics • software and automation • integrated solutions hdx mass spectrometry corona virus outbreak global health challenges pandemic vaccine production contamination control strategy endotoxin contamination endotoxin control and clearance endotoxin removal fine chemicals lipopolysaccharide fouling model vmax method pmax method bpsa perfusion bioreactor single-pass tangential flow filtration sedimentation velocity analytical ultracentrifugat virus assay cell assay virology rna therapeutics rna delivery helium integrity test novel cell models immunotherapy research immunotherapy immunotherapeutics genome editing technology generating tumor-associated antigen panels engineered custom cell line engineered cell line antigen cell lines batch release microbial ingress closed sampling perfused seed train integrated systems perfusion filter n-1 novel perfusion cryopreservation peg linkers spectroscopy product recovery somasundaram g subhasis banerjee acoustic cell processing cell therapy manufacturing viral vector therapy blazar viral screening bioinformatics next generation sequencing rapid molecular method biologic therapy biotherapeutic lai long-acting injectable lysis helium targeted drug delivery rna vaccines rcl testing lentivirus testing biosafety and characterization testing upstream foot and mouth (fmd) disease granulated pharmaceutical raw materials biopharma media filtration barrier filters compacted excipients mrna therapies mrna production process mrna delivery systems therapeutics roller compaction raw materials single-use manufaturing e. coli recombinant growth factor antibody drug conjugates dry granulated excipients technically unavoidable particles biocontinuum™ bioprocess lifecycle management process verification (cpv) bio4c™ processpad advanced analytics smart data management bio4c™ chromatography resin monoclonal antibody purification preparative chromatography analytical chromatography oxygen mass transfer clinical scale bench scale bioreactors high-viscosity tff reverse osmosis nanofiltration viral clearance studies fed-batch production fda regulatory guidance dust formation of chemicals excipient flowability compressibility bulk density flow continuous tablet manufacturing ophthalmic excipients ophthalmics microbial contamination excipients in china excipient regulations biosolve ophthalmic formulation cost of goods sold process model pva in ophthalmics viral vectors sars-cov2 mers ebola h1n1 influenza chemicals pharmaceuticals coriolis recombinant pharma manufacturing efficiency npi pharmaceutical-grade sucrose intein affinity capture discovery continuous virus inactivation intensified capture next-generation bioprocessing filter plugging bulk filtration free flowing excipients downstream unit operations scalable purification data driven biopharma manufacturing reduced caking excipients