MilliporeSigma

milliporesigma merck bioprocessing formulation regulatory biopharmaceutical manufacturing next generation bioprocessing single-use downstream processing biopharmaceuticals cell culture media cell culture process development- biomanufacturing monoclonal antibody continuous bioprocessing sterile filtration webinar bioreactor upstream processing gene therapy pharmaceutical clarification chromatography biomanufacturing tangential flow filtration biosafety cell line development final fill cell & gene therapy biosafety testing process intensification purification solid formulation patient safety filtration excipients single-use systems next generation processing antibody drug conjugate viral safety mabs risk assessment integrity testing contract dev & mfg viral clearance regulatory guidelines bioreliance risk mitigation vaccines manufacturing clarification/harvest vaccine manufacturing virus removal cell therapies viral contamination adcs final sterile filtration active pharmaceutical ingredient drug development process mabs diafiltration ultrafiltration raw materials regulatory considerations virus detection biologics safety chromatography purification product recovery adeno-associated viruses (aav) aav adc ultrafiltration/diafiltration & concentration pharma chromatography resins biopharma continuous processing monoclonal antibodies scale up life science pharmacetuical process development sterilization buffer & media prep product characterization virus extractables and leachables viral vector manufacturing cell and gene therapy adeno-associated virus perfusion conjugation harvest e2e chozn sterile sampling cell therapy viral vector biosimilars mab biosafety services api viscosity reducing excipients downstream mrna vaccines ccm sterile filtration & bioburden control tech transfer vaccine processing adventitious virus contamination cell line perfusion media risk management intramuscular injection intravenous to subcutaneous iv to sc iv to subq protein viscosity reformulating protein biotherapeutics subcutaneous formulation development therapeutic protein formulations intradermal injection high concentration protein formulations biotherapeutic formulation sptff bpog collaboration emprove pupsit plasma continuous manufacturing covid-19 cmo chemistry contract manufacturing drug delivery upstream and downstream processing seed train training cell culture seed train process validation bioburden qbd healthcare single-use bioreactors regulatory requirements lentivirus novel therapies upstream process viscosity reducing additives viscosity reducing agents extractables protein stability molecule bioprocess development single use case study quality by design large scale cell culture cho tff virus inactivation quality biotechnology excipient research liquid formulation 3d printing fluid management chromatography/purification api synthesis bioburden control validation sterilizing filtration host cell protein single-pass tff gene therapy manufacturing regulatory affairs / validation media filtration upstream solubility enhancement mrna therapies cell line characterization regulatory/validation education and training innovation aseptic filter bioavailability usp <665> depth filtration single-use technology solid dose next-gen processing virus prevention automation operator safety cgmp stem cells intravenous injection flocculation downstream purification bioprocess orchestration software human mesenchymal stromal hmscs regulatory documentation toxicology emerging biotech cation exchange chromatography membrane chromatography vgt microfiltration flow-through polishing mrna vlp active pharmaceutical ingredients gene editing bioburden reduction biocontinuum chozn gs-/- expression system viral therapies supply chain draft annex 1 viral product manufacturing sterilizing grade filter pcr anion exchange chromatography dry granulation natrix mab development biopharmaceutical facility of the future adventitious virus car-t virus safety concentration stability enhancement sterile filtration / prefiltration viral & gene (vgt) therapy manufacturing provantage biodevt & e2e services automation system testing considerations continuous process a&f final fill vial mesoporous silica formulations chemical synthesis mesoporous silica technology emprove® api amorphous formulation mesoporous silica mrna manufacturing process lot release testing gmp cell banking biotech process activated pegs aav therapy lipid based rna formulations pva biologics manufacturing active and formulation pdadmac subhasis banerjee pdna plasmid dna solid dosage fc-fusion protein somasundaram g semi-solid formulation liquid dosage form lipopolysaccharide fine chemicals dolcoretm maycoretm chetosensartm solid dosage drug formulation endotoxin removal api stability endotoxin control and clearance endotoxin contamination contamination control strategy chromatpgraphy protein a membrane mscs clinical development microcarrier cell bank zika lipid nanoparticles lipids peg biologic drugs advanced drug delivery cld protein aggregation fda bacterial fermentation drug release protein purification scalability nanoparticulate impurities high viscosity tff buffer josephine cheng biologics viscosity reduction platform process development hot melt extrusion replication competent virus polyvinyl alcohol dsp platform recombinant protein 3d printing technology normal flow filtration filter in vitro filter integrity testing bioreliance services single-pass tangential flow filtration closed sampling virology sedimentation velocity analytical ultracentrifugat perfused seed train excipient risk assessment integrated systems perfusion filter perfusion bioreactor n-1 bpsa novel perfusion cryopreservation analytical development titer big data supply chain risks biologic therapy rapid molecular method next generation sequencing bioinformatics viral screening blazar fast track approach • data visualization • cpv cell therapy manufacturing • continued process verification acoustic cell processing • laboratory information management system (lims) • manufacturing execution system (mes) • enterprise resource planning (erp) • biopharmaceutical processes spectroscopy peg linkers hdx mass spectrometry • integrated solutions • software and automation • software analytics • next-generation bioprocessing • data management virus assay closed manufacturing batch release antigen cell lines immunotherapy immunotherapy research immunotherapeutics engineered custom cell line engineered cell line genome editing technology cell assay novel cell models generating tumor-associated antigen panels rna therapeutics viral genome viral capsids auc assay tableting rna vaccines sustained release rna delivery targeted drug delivery long-acting injectable microparticle lai 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 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 human vaccine 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 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 biochemical technology 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 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 emerging markets 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 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 white paper 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 : 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