MilliporeSigma

milliporesigma merck bioprocessing formulation regulatory next generation bioprocessing biopharmaceutical manufacturing single-use downstream processing biopharmaceuticals cell culture media cell culture continuous bioprocessing monoclonal antibody process development- biomanufacturing sterile filtration chromatography webinar gene therapy upstream processing pharmaceutical bioreactor clarification tangential flow filtration biomanufacturing biosafety cell line development cell & gene therapy final fill biosafety testing solid formulation purification process intensification single-use systems excipients patient safety filtration contract dev & mfg viral clearance viral safety mabs risk assessment integrity testing antibody drug conjugate regulatory guidelines next generation processing vaccine manufacturing clarification/harvest manufacturing vaccines bioreliance virus removal risk mitigation final sterile filtration ultrafiltration diafiltration active pharmaceutical ingredient drug development viral contamination cell therapies adcs biologics safety virus detection regulatory considerations raw materials process mabs biopharma product recovery adc ultrafiltration/diafiltration & concentration aav adeno-associated viruses (aav) chromatography purification pharma chromatography resins cell and gene therapy buffer & media prep harvest monoclonal antibodies adeno-associated virus product characterization sterilization life science scale up conjugation virus viral vector manufacturing perfusion pharmacetuical process development extractables and leachables continuous processing viscosity reducing excipients sterile filtration & bioburden control downstream mrna vaccines cell therapy sterile sampling mab ccm e2e api biosafety services cell line risk management viral vector chozn adventitious virus contamination tech transfer perfusion media biosimilars vaccine processing viscosity reducing agents viscosity reducing additives therapeutic protein formulations subcutaneous formulation development reformulating protein biotherapeutics protein viscosity iv to subq iv to sc intravenous to subcutaneous intramuscular injection intradermal injection high concentration protein formulations biotherapeutic formulation quality by design protein stability healthcare continuous manufacturing virus inactivation pupsit covid-19 drug delivery upstream process single-use bioreactors chemistry tff single use bioprocess development sptff collaboration plasma training regulatory requirements lentivirus quality novel therapies emprove molecule case study cho biotechnology seed train cell culture seed train process validation bioburden qbd cmo upstream and downstream processing contract manufacturing large scale cell culture extractables bpog intravenous injection regulatory/validation validation bioburden control 3d printing single-pass tff media filtration upstream mrna therapies research automation bioprocess orchestration software solid dose depth filtration downstream purification single-use technology fluid management chromatography/purification api synthesis sterilizing filtration host cell protein gene therapy manufacturing regulatory affairs / validation solubility enhancement cell line characterization education and training innovation aseptic filter bioavailability excipient liquid formulation usp <665> toxicology regulatory documentation virus prevention cgmp hmscs stem cells human mesenchymal stromal operator safety next-gen processing flocculation protein purification protein aggregation automation system a&f vlp subhasis banerjee somasundaram g liquid dosage form lipopolysaccharide fine chemicals endotoxin removal endotoxin control and clearance endotoxin contamination contamination control strategy chetosensartm maycoretm dolcoretm viscosity reduction platform josephine cheng bacterial fermentation cld mab development biopharmaceutical formulations aav therapy emprove® api chemical synthesis solid dosage replication competent virus dry granulation 3d printing technology fc-fusion protein pdadmac concentration mrna manufacturing process mrna cation exchange chromatography biocontinuum nanoparticulate impurities recombinant protein biologics pdna plasmid dna filter integrity testing buffer anion exchange chromatography flow-through polishing microfiltration bioburden reduction normal flow filtration pva active pharmaceutical ingredients advanced drug delivery drug release vgt lipid based rna car-t stability enhancement facility of the future process development active and formulation dsp platform viral & gene (vgt) therapy manufacturing sterile filtration / prefiltration draft annex 1 biologics manufacturing provantage biodevt & e2e services mesoporous silica formulations mesoporous silica technology amorphous formulation mesoporous silica lot release testing gmp cell banking activated pegs peg membrane chromatography natrix pcr supply chain viral therapies gene editing filter polyvinyl alcohol hot melt extrusion semi-solid formulation solid dosage drug formulation api stability clinical development cell bank lipid nanoparticles lipids zika microcarrier mscs protein a membrane chromatpgraphy in vitro bioreliance services fda chozn gs-/- expression system viral product manufacturing sterilizing grade filter emerging biotech biotech process final fill vial virus safety adventitious virus testing considerations continuous process biologic drugs scalability high viscosity tff tablet coating polyvinyl tablet coating tio2 alternative titanium dioxide alternative tio2 titanium dioxide calcium carbonate parteck ta increase lifetime resin performance cleaning efficiency protein a column eshmuno naoh cleaning in place cip ethylene glycol cation exchange protein a excipient impact protein stabilization particle formation agitation stress protein solutions surfactants api processing cocrystal formation salt formation api solubility spike protein sars-cov-2 sac equipment qualification cdc adcc actives and formulation regulatory expectations biophorum pharma raw material risk extractables risk assessment leachables risk assessment pharmaceutical risk management filtration technology extractables data remote audit remote virtual technology technology audits audit qc testing gmp gene therapies therapeutic medicine viral gene therapy ngs assays ngs identity testing large scale manufacturing melt based 3d melt based polymers 3d t cell ekko™ select system dmso car-t manufacturing acoustic cell processing syste ekko™ virus testing q5a ich q5a process orchestration operational efficiency product quality process orchestrator bio4c covid-19 pandemic west african pandemic technovax innovative biotech sars-cov-2 vaccine cov-2 vaccines vaccine collaboration virus like particle x-ray x-ray sterilization rca assay adenoviral vectors rca testing high intensity sweeteners sucralose neotame types of oral dosage form tablets dosage forms solid pharmaceutical dosage form solid dose pharmaceuticals solid dosage formulation solid dosage forms include oral solid dosage forms pharmaceutical solid dosage forms types of oral solid dosage forms oral solid dosage oral solid oral solid dosage manufacturing oral dosage forms formulation of tablet dosage form dosage form of tablet adc express™ hydrophilicity adc payloads adcore product line small scale adcs adc therapies solubility risk of cross-contamination sterile medicinal products eu gmp annex 1 draft sf9 rhabdovirus-negative sf-rvn performant rhabdovirus-free bevs baculovirus expression vector complex injectables viscous formulations nanoparticles liposomes viscosity reducing excipient protein viscosity on syringeability innovative technologies in biomolecule formulation helium integrity testing helium sterilizing grade filters lysis viral vector therapy pva in ophthalmics ophthalmic formulation ophthalmics ophthalmic excipients excipient flowability dust formation of chemicals reduced caking excipients free flowing excipients pharma manufacturing efficiency dry granulated excipients roller compaction raw materials compacted excipients granulated pharmaceutical raw materials viral clearance studies virus bank services virus filters recombinant production recombinant development mab production paul genest filter performance 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 adc therapies dolastin giuseppe camporeale ashok kumar payload intermediate linker-payload speed up high-potent payloads leo ohrem solid dose formulation xiaolong sun trends in vaccine manufacturing quality management systems qmss jerome dalin pharma grade sugar excipient(s) polyol(s) low npi sucrose bulking agent biomolecules pharma(ceutical) grade sucrose sucrose pharmaceutical excipient stabilize biomolecules syringability subcutaneous administration subq reduce viscosity synergistic effects formation virus inactivation steps thierry burnouf subcutaneous igg infusion scalable plasma process safety and quality of plasma igg removal of solvent removal of detergent purification process plasma immunoglobulin purification plasma igg fractionation flow flow-through-mode chromatography flow-through purification aseptic filtration affinity chromatography buffer and media prep fc-fusion chozn-gs system chozn gs chozn-gs bacterial retention testing validation services 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 gmp-compliant mesenchymal stem cell growth mesenchymal xeno free culture high yields e&l process validation strategy risk-based approach technology transfer cdmo end to end nanoparticulate impurities sucrose excipent protein handling challenges capsid protein cqa critical quality attributes orthogonal method orthogonal methods technically unavoidable particle profiles tupp emprove® chemicals emprove® stem cell xeno free preclinical : ex vivo lsm laser scanning microscopy optical coherence technology coating formulation development oct particle designed pva coating process coating bio4csuite software and automation saa software closed processing single-use tff hc agnostic hcp id hcp host cell protein impurities biotherapy purity host cell proteins mass spectrometry cellculture filterselection cellculturemedia mediafiltration powder feeding cm electrostatic charge crazy powder (qc) test methods mycoplasma methods for sterility quality control testing test methods compen-dial proteins peptides injectables antibodies viral inactivation filaments sterility assurance roller compaction granulated material raw material handling caking and clumping manufacturing efficiency protein a resin scale-up development virusexpress™ lentiviral production platform mobius® single-use bioreactors templated manufacturing process suspension-based lentivirus production bioreactor process scalable upstream bioreactor process lentiviral vector production filament-based hot melt extrusion process pharmaceutical industry pharmaceutical manufacturing pharmaceutical dosage pharmaceutical dosage forms additive manufacturing formulation development microbial retention sterilizing filters filter validation aggregates perfusion technologies perfusate viral contaminant cell banks bio4c™ processpad data management software biocontinuum™ bioprocess lifecycle management process verification (cpv) data visualization & analysis 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 filter selection biopharm fed-batch production high-viscosity tff reverse osmosis nanofiltration fda regulatory guidance rcl testing lentivirus testing biosafety and characterization testing foot and mouth (fmd) disease virus retention contamination mrna production process mrna delivery systems therapeutics single-use manufacturing antibody drug conjugates e. coli recombinant growth factor technically unavoidable particles tupps chemicals pharmaceuticals coriolis recombinant npi pharmaceutical-grade sucrose intein affinity capture discovery continuous virus inactivation intensified capture next-generation bioprocessing filter plugging bulk filtration downstream unit operations scalable purification data driven biopharma manufacturing compressibility bulk density flow continuous tablet manufacturing microbial contamination tank cycling flexible manufacturing continuous diafiltration excipients in china excipient regulations biosolve cost of goods sold process model viral vectors sars-cov2 mers ebola h1n1 influenza corona virus outbreak global health challenges pandemic vaccine production fouling model vmax method pmax method bpsa perfusion bioreactor single-pass tangential flow filtration virology sedimentation velocity analytical ultracentrifugat virus assay cell assay viral genome viral capsids auc assay tableting sustained release 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 peg linkers spectroscopy acoustic cell processing cell therapy manufacturing blazar viral screening bioinformatics next generation sequencing rapid molecular method biologic therapy lai long-acting injectable microparticle targeted drug delivery rna delivery rna vaccines rna therapeutics generating tumor-associated antigen panels novel cell models genome editing technology engineered cell line engineered custom cell line immunotherapeutics immunotherapy research immunotherapy antigen cell lines batch release closed manufacturing closed sampling perfused seed train excipient risk assessment integrated systems perfusion filter n-1 novel perfusion cryopreservation analytical development titer big data supply chain risks facility intensification buffer delivery process monitoring regulatory compliant continued process verification cpv purification template disposable technology continuous chromatography biosimilar mab horizon2020 virus spiking api registration cgt formula single-use connectors single-use assemblies integrity testers cell & gene therapy (cgt) services biopharm ingredients msat post approval changes pei eu commision falsified medicine directive regulations chinese regulation intensified mab purification preclinical stage clone selection biopharma training apac emerging markets efficiency in media preparation compaction of cell culture media and single chemic buffer concentrates footprint saving buffer management cell lines cell culture media and supplements multi-use systems hardware platform assay platform manufacturing slc scale-up solubility activated polyethylene glycols polyethylene glycols liphophilic payload pk/pd monodisperse linkers clinical trial kla process scalability bioprocess international map/hap supply robustness forecast collaborative forecasting phenylketonuria gmp manufacturing glycosylation mass spectometry n-glycan profiling of monoclonal antibodies potency white paper prefilter bioprocesing intravenous immunoglobulin ivig purification process optimization drug approval accelerate product certification pasteurization viral risk mitigation htst small molecule series smallmoleculeseries pla/plga polymersmall molecules optimum polymer technologyformulation technologies synbiosys® multi-block polymer introductionparente polymer based drug delivery systems polymer based parenteral controlled-release drug d particles biodevelopment synthetic lipids philipp buehle 2d data matrix barcode 2d barcode barcode drug manufacturer raw material supplier raw materialsr digital innovation dna vectors douglas bowman appropriate quality martin wisher human vaccine virus harvest virus seed vaccine cell bank business plan zfn funding corporate funding startup venture capital alison armstrong expression systems viral risk process sampling novaseptum ich q10 genotoxicity serum free media fetal bovine serum bioassays small-molecule api drypour mobius virus contamination modified expression systems clean rooms stainless steel ttc elsie media prep filter sizing high throughput screening viral filtration biochemical technology