Merck Life Sciences

merck milliporesigma formulation regulatory bioprocessing next generation bioprocessing biopharmaceutical manufacturing single-use downstream processing biopharmaceuticals process development- biomanufacturing tangential flow filtration continuous bioprocessing gene therapy monoclonal antibody cell culture media cell culture clarification webinar biosafety bioreactor cell line development chromatography upstream processing cell & gene therapy biomanufacturing final fill pharmaceutical sterile filtration regulatory guidelines biosafety testing solid formulation purification viral clearance single-use systems excipients process intensification risk assessment bioreliance next generation processing clarification/harvest contract dev & mfg antibody drug conjugate vaccine manufacturing mabs vaccines risk mitigation cell therapies process mabs diafiltration active pharmaceutical ingredient viral safety regulatory requirements virus removal patient safety adcs harvest ultrafiltration ultrafiltration/diafiltration & concentration cell and gene therapy biosafety services aav adeno-associated viruses (aav) sterilization chromatography purification drug development viral contamination buffer & media prep adeno-associated virus adc sterile sampling product characterization raw materials case study viral vector manufacturing virus detection biologics safety chozn chromatography resins viscosity reducing excipients mrna vaccines healthcare conjugation cell therapy mab e2e api chemistry tff manufacturing extractables and leachables scale up cell line virus viral vector perfusion vaccine processing pharmacetuical process development large scale cell culture viscosity reducing agents viscosity reducing additives protein viscosity iv to subq iv to sc intravenous to subcutaneous intradermal injection high concentration protein formulations biotherapeutic formulation sterile filtration & bioburden control validation research continuous manufacturing monoclonal antibodies upstream process solubility enhancement single use bioprocess development sptff collaboration plasma education and training training lentivirus novel therapies risk management sterilizing grade filters biotechnology seed train cell culture seed train adventitious virus contamination process validation bioburden qbd tech transfer cmo chozn gs-/- expression system next-gen processing perfusion media contract manufacturing biosimilars therapeutic protein formulations reformulating protein biotherapeutics subcutaneous formulation development intravenous injection intramuscular injection viscosity reduction platform regulatory/validation bioburden control single-pass tff downstream mrna quality by design protein stability automation solid dose virus inactivation downstream purification single-use technology pupsit covid-19 drug delivery fluid management chromatography/purification api synthesis sterilizing filtration host cell protein gene therapy manufacturing regulatory affairs / validation single-use bioreactors amorphous formulation cell line characterization filtration innovation aseptic filter life science continuous processing bioavailability liquid formulation usp <665> vlp clinical development molecule toxicology cell bank extractables bpog virus prevention cgmp pharma stem cells human mesenchymal stromal operator safety protein purification protein aggregation automation system a&f viscosity reducing excipient protein viscosity on syringeability innovative technologies in biomolecule formulation adc therapies chetosensartm maycoretm dolcoretm josephine cheng bacterial fermentation cld gmp-compliant mab development aav therapy emprove® api chemical synthesis solid dosage replication competent virus 3d printing technology 3d printing pdadmac data visualization & analysis concentration mrna manufacturing process cation exchange chromatography tupps nanoparticulate impurities recombinant protein biologics pdna plasmid dna bioprocess orchestration software final sterile filtration anion exchange chromatography depth filtration flow-through polishing microfiltration integrity testing bioburden reduction normal flow filtration advanced drug delivery drug release pva vgt lipid based rna car-t facility of the future excipient risk assessment ccm process development active and formulation buffer biocontinuum dsp platform viral & gene (vgt) therapy manufacturing sterile filtration / prefiltration draft annex 1 excipient provantage biodevt & e2e services mesoporous silica technology mesoporous silica formulations mesoporous silica lot release testing activated pegs peg membrane chromatography natrix pcr cho supply chain viral therapies gene editing mass spectrometry filter polyvinyl alcohol hot melt extrusion semi-solid formulation emprove solid dosage drug formulation api stability upstream and downstream processing lipid nanoparticles lipids zika mscs protein a membrane chromatpgraphy in vitro regulatory documentation viral product manufacturing filter integrity testing emerging biotech biotech process ich q10 hmscs virus safety continuous process stainless steel clean rooms biologic drugs tablet coating polyvinyl tablet coating tio2 alternative titanium dioxide alternative tio2 titanium dioxide calcium carbonate parteck ta resin performance increase lifetime cleaning efficiency protein a column eshmuno a 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 dormulation regulatory expectations biophorum pharma raw material risk leachables risk assessment extractables risk assessment pharmaceutical risk management filtration technology extractables data remote technology remote audit remote virtual technology technology audits audit qc testing gmp gene therapies therapeutic medicine ngs ngs assays viral gene therapy 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™ ich q5a q5a virus testing process automation process orchestration operational efficiency product quality process orchestrator bioprocess orchestration softw bio4c west african pandemic technovax innovative biotech sars-cov-2 vaccine cov-2 vaccines vaccine collaboration virus like particle x-ray x-ray sterilization adenoviral vectors rca testing rca assay rca high intensity sweeteners sucralose neotame types of oral solid dosage forms types of oral dosage form tablets dosage forms solid pharmaceutical dosage form solid dose pharmaceuticals solid dosage formulation solid dosage forms include solid dosage forms pharmaceutical solid dosage forms oral solid dosage manufacturing oral solid dosage forms oral solid dosage oral solid oral dosage forms formulation of tablet dosage form dosage form of tablet adc express™ hydrophilicity adc payloads adcore product line small scale risk of cross-contamination sterile medicinal products biopharmaceutical eu gmp annex 1 draft bevs performant rhabdovirus-free sf9 rhabdovirus-negative sf-rvn baculovirus expression vector complex injectables viscous formulations nanoparticles liposomes microbial ingress helium integrity test helium lysis viral vector therapy subhasis banerjee somasundaram g liquid dosage form lipopolysaccharide fine chemicals endotoxin removal endotoxin control and clearance endotoxin contamination contamination control strategy 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 dolastin giuseppe camporeale ashok kumar payload intermediate linker-payload 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 subcutaneous administration subq 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 fc-fusion 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 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 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 mycoplasma methods for sterility quality control testing test methods compen-dial proteins peptides injectables sterility assurance 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 mobius® single-use bioreactors templated manufacturing process suspension-based lentivirus production bioreactor process scalable upstream bioreactor process scalability lentiviral vector production 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 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 fed-batch production fda regulatory guidance rcl testing lentivirus testing biosafety and characterization testing upstream foot and mouth (fmd) disease biopharma media filtration barrier filters mrna therapies mrna production process mrna delivery systems therapeutics single-use manufaturing e. coli recombinant growth factor antibody drug conjugates technically unavoidable particles 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 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 sedimentation velocity analytical ultracentrifugat virus assay cell assay virology viral genome viral capsids 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 peg linkers spectroscopy product recovery acoustic cell processing cell therapy manufacturing blazar viral screening bioinformatics next generation sequencing rapid molecular method biologic therapy biotherapeutic lai long-acting injectable targeted drug delivery rna vaccines rna therapeutics rna delivery 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 closed sampling perfused seed train integrated systems perfusion filter n-1 novel perfusion cryopreservation analytical development titer mitigating risks big data facility intensification buffer delivery process monitoring regulatory compliant continued process verification cpv purification template horizon2020 disposable technology continuous chromatography biosimilar mab virus spiking api registration formula single-use connectors single-use assemblies integrity testers cell & gene therapy (cgt) services biopharm ingredients biologics manufacturing post approval changes process impurities assays biotherapy pei eu commision falsified medicine directive chinese regulation regulations 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 industry 4.0 multi-use systems hardware platform assay platform manufacturing solubility slc scale-up gmp cell banking 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 n-glycan profiling of monoclonal antibodies potency single-pass tengential flow filtration single-pass 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 biodevelopment synthetic lipids testing considerations microcarrier philipp buehle 2d data matrix barcode 2d barcode barcode drug manufacturer raw materials supplier digital innovation biotech events science douglas bowman appropriate quality bioreliance services martin wisher european pharmacopoeia fda agent contamination virus seed business development zfn risk solvent funding corporate funding startup venture capital alison armstrong final fill vial viral contamincation viral risk process sampling novaseptum genotoxicity serum free media fetal bovine serum bioassays small-molecule api drypour mobius adventitious virus ex-cell advanced ucoe expression vectors shear protection bioprocess performance loss lot-to-lot variation poloxamer 188 pluronic-f68 media prep