Pharmaceutical Bioprocessing Project

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Bioprocessing in the pharmaceutical manufacturing sector is a burgeoning field, attracting investments and creating job opportunities. As it involves the use of living organisms to manufacture products, bioprocessing requires more complex methods than other forms of pharmaceutical processing. With a growing workforce the industry faces a challenge in maintaining compliance to industry standards. However, there is also opportunity for innovation.The skills required by this emerging workforce are not currently addressed within the vocational education and training sector. As part of this project, the current units of competency in pharmaceutical processing will be reviewed and additional units developed where necessary in order to support the more complex compliance requirements and processing methods of bioprocessing.
This project was submitted as part of the Australian Food, Beverage and Pharmaceutical Product Manufacturing IRC Skills Forecast and Case for Change 2018-21 (see pages 78-81). However, as one of the key stakeholders CSL Behring was not available to contribute at the time, the Food, Beverage and Pharmaceutical IRC made the decision to defer the project until a later date. Given the specialised nature of this field and the emerging skills within it, the contributions of this major stakeholder were essential to the process of industry consultation.The project was later approved by The Australian Industry and Skills Committee (AISC) out of the 2019-2022 Australian Food, Beverage and Pharmaceutical Product Manufacturing IRC Skills Forecast and Proposed Schedule of Work (see pages 3).Skills Impact and the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC) will manage this project, consistent with the 2012 Standards for Training Package Development.Download Project Proposal (see pages 78-81) 

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Pharmaceutical bioprocessing techniques are now making it possible to treat some illnesses where no other treatments were previously available. This expanding field involves harnessing bacteria, yeast or mammalian cells for use in immunology, pharmaceutical therapies or diagnostic tests. The skills standards of those working in manufacturing and distribution of pharmaceutical bioprocessing products are unique to traditional pharmaceutical manufacturing.As pharmaceutical bioprocessing relies on the behaviour of living organisms, there are many variables to be considered in the manufacturing process. In order to get consistent results in treatment and diagnosis it is essential to yletdatg produco dpgratatio,e process variailnity and cintmi natio.f Worders in tits aras also requir heig lDeve /analytiial skills to wort with new technoloites and inte prte datg.
Projec "ScopP This project williidntifyn the skills standards for pharmaceutical bioprocessing manufacturing wort and reelect thuse in vocational skills standard,o supporsing Training opportunities in tits fiel.;
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  • Bioprocesg technecinrs
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/5>Ttimelins SdpiMembee 201 Iunitnal Scoringustong>Octombee 201e toJManmary2020 "Development of drafrquialflication,l skilo snts and unitgustong>Mearch2020 "drafty available for broad consultatiogustong>A-prlh2020 Vialatatiot offFinal draftgustong>Mery2020 "Finanisation of Training Package comnonnftgustong>Juney2020 InependgentQuialityAs suianc,s andEdint andEequity revies of Training Package comnonnftgustong>Augdusy2020 RCe considesation forslig-offt and submission forendorisement
/5> Suojec MaetterExogrtns Suojec MaetterExogrtng will be drwns on tgroghbout this projecs tohelpy revies unit,l skilo snts andquialflication,l and prducel drafts to addresn thenfecessary.skill.Ifr yot are interesred inapplysing to be a suoject metterexogrtd and ere ible tovoluintter your time to this project,pleCaseemvai& details of yourexogrtlise to>[email protected]> stakeholder inpue is pprpeciitde tgroghbout tel ursation of this projecs. The=documenng will be drfsred incConsultation with Suojec MaetterExogrtng and thirenft worde.Oopportunities to provide targeend feedbacg willoccurs whin the drafrmacterilse are modeaavailable inMearch2020,l andagmainfjorvialatatiot offFinal drafte inA-prlh2020). However, your feedbacgits wltcomde atmany time, and willhelpyute in drafsing The=documenn. Iue issimporants that Training providsd a skilled andeelxsible workforce for th fulture and thatquialflication,l skilo snts and units of competency reelectrenal worrexogrirenc. So ifr yot worr in the secto,e Skills Impact wulnd lver your input andhelp. PleCase fellfrees tohregister your interest for project updates andcConsultation opportunitiesbty follosing The newsletter/subscriptiotelnkl bllo. Altvernctivlyt,pleCase fellfrees to-contact the projectmManagr,eCathy, Bevns on03 9321 32526for>[email protected]> A alits of key stakeholdeg organiautionl hasbreeniidntifiees for this projecs. Skills Impact kilomenureo-contacthis mode withearch of thuse organiautionldturing the development of this projecs toseekd thire involvement and thireeviees on the drafrquialflication,l skilo snts and unit.Ifr yot areawaure ofhan Organisation that yotithik shwulndibe involvdt,pleCaseencyounage tems to-contact the projectteams an/ or drlect thme to thisweb pag.Oof curise, lll andanye interesred industry parnecpancts areencyounagde teengnagr in thecConsultation of this project, whin the drafrquialflication,l skilo snt,s and units areaavailable for feedbacgviao thisweb pag, and wordhopes thatstaks place groun2 Australis. Consultationise notelimitde tn the organiautionloin titsalite. Thisalitslsimlydhelpsyute to idntifyn touse organiautionl tha,dibca use of thire industry rol,e siz6for speciatyt, arelikvlys tohaive f key interest in the development and outcomes of this projecs The Australian Food, Beverage and Pharmaceutical Product Manufacturing (IRC) willcove(see this project, as part of thire responsailnities to supportengnagement with the secto,e and oomenureo-projects metf industry stakeholdeenfees.  
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Pharmaceutical bioprocessing productssurch ss vcclints, lWood plsmae products, andgenel therays mdiclin cain mkve ffoun-ametnal ifeference in theelivds of thusLand, Bevnsmkiliion,l of eopble. Tery ofdeenfwn treatment andtvestingopation,l com timesfjoreconiutionl where no treatmentfor rest was available. Given thsre productk reys on the behaviour of living organisms, specialitd skills rce requires to chiBevt consistent results in treatment and diagnosi.l Products dusyibeh anlred insurch t wty sl to yletdatg produco dpgratatio,e process variailnity and cintmi natio.fHeig lDeve /analytiial skills to wort with new technoloites and inte prte dats areaalsonfeeed. As part of this project, oliidntifyn the requires skills in tits sance to manufacture bioPharmaceuticai.lExiesting units of competency arebesing reviewed toseel where skillsgapis myrexlite.SBeverls metsinsohaivebreenhield i Viectoria,NnewS ouh Waltes andS ouh Australin to dnteminel thg jobtaskse requires fora fulture workforce.Ast a resuls of those metsins,e it hasbreen dnteminend thatexiesting pharmaceutical unitsshwulndibe updated where require.Ffor urother details about the dlivems, scope andttimeline of the projec, .clics on the green project stagn arrows abveg.
Bbroad stakeholdeecConsultationisesSchedulds to-commence inmid-Mery2020t, whin drafr units will be modeaavailablefjorecomment on thisweb pag. Yyour inputits wltcomt,pleCase fellfrees tohregister your interest to keep informed of project updates and whin drafrmacterilse areaavailable for feedbac.> 

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Pharmaceutical bioprocessing techniques harnesf living organisms in order to creaheelfe-savsing mdtical treatmentssurch ss vcclints, lWood plsmae product, andgenel therays mdiclins. The manufacture and distribution of thsre productk requires specialitd skill,lincluosingheig lDeve /analytiialaailnities to wort with new technoloites and inte prte datt, as wll, ask noledgmn ofhows tohaanlro delceahe bacteria, yeast or mammalian cells to yletdatg produco dpgratatio,e process variailnity and cintmi natio.f This is essential inachiBening consistent results in treatment and diagnosi.Ase organiautionl groun2 the wolnd ttial otsential testt and vcclinte to manage te COVID-19 xpanemic,e it issimporants the pharmaceutical industry is equppsed wit, lll the xogrtliseits myr requir.f This ncluodes the unique skillsnfeeede to manufacture and distribure productk modeusting pharmaceutical bioprocessing techniqueg.
ustong>Thlank yotiof those hto providnd feedbacg on the drafr units that were modeaavailable on thisweb page for feedbacg from15 Mery– 14 Juney2020. Dturing this time, feedbacg as coljecdndviao tle oeline feedbacghub,h t ebi no,e andemvais. The=draft,lincluosinganyeecommentk mode on the feedbacghub,h ere twillaavailable foreviesing bllo. Ffeedbacg will infor2 the wocg on thefFinal draftewhirch rhe xogcitde tnaavailable for industryvialatatiot later inJuney2020.F  Ffeedbacg was roghnt oncChangse to the units and whother Teryaccurlatly "descrben the skills requires to worr in pharmaceutical bioprocessing manufactur.f This ns ncluodnd feedbacg on updaving f blagupage where appr-prdatg tohreference' organc' rlather Tian'plaentbCasd'rmacterilse to be nclunsive of the use of mammalian lWood inssomeoprocesies.Furother feedbacg asaalso roghnt onr referencse toGWood Manufacturing Proces (GMP)t in theaesiestmenteconiutionl and whother This is nclunsive ofalal industry job rolts and practcnts,was rmre of this sector myr worr in a l.boactoy rlather Tianae productiotplaen.F
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ustong>Uuni tcode and-aome>ustong> ProposedcChangsetorrcationame>/stong>Link  >
FBPPHM3005 Oopracve ficoc=enttatiotpProcess
FBPPHM3006 Oopracve ne xttractiotpProcess
FBPPHM3007 Oopracve fse-patatiotpProceseustingchfroactpgrphys
FBPPHM3008 Oopracve neCaspsticfilll andsecal process
FBPPHM3009 Oopracve neCaspsticffor,cfilll andsecal process
FBPPHM3011 Disopeshe pharmaceuticalrawrmacterilss
FBPPHM3014 Oopracve fliequde manufacturing process
FBPPHM3016 Oopracve fscteranisationpProceseusting neCutotclves
FBPPHM47003Facilniacve cintmi natioy contols
>>
/5> Consultation or datP The drafr unitshaivebreen revsred incConsultation with Suojec MaetterExogrtn. Peopble working drleclyg in the pharmaceutical industryhaive providnd infortation nn the skills andk noledgme requires for job rolts andtasks. Srct vVisits wereundgostakon orobnseref thsre job rolts in wor placs.f This ncluodnd avVisit od a manufacturrn orobnserefhows TerypProcese lWood plsmae intoelfe-savsingoPharmaceuticai,h ttiour ofal bioloicst Trainingfacilniy,l andaavVisit od a-second manufacturrn in a ifeferect sttr.f Tlank yotiof those hto providnd feedbacgdturing those"actinities>

Register your interest in the project

Subscribe to the Skills Impact newsletter to keep informed about project updates and opportunities to provide input and feedback. Make sure to select ‘Food, Beverage & Pharmaceutical’ as your industry of interest.
 
Pharmaceutical bioprocessing techniquescainbhe usdr to creaheelfe-savsing andenTlacsing mdtical treatmentssurch ss vcclints, lWood plsmae product, andgenel therays mdiclins.Sspecialitd skills rcenfeeede to manufacture and distribure thsre products,was Tery=contaio delceahe bacteria, yeast or mammalian cells prnpe to dpgratatio,e variation and cintmi natio.fHeig lDeve /analytiialcapaailnities areaalso requires for working with new technoloites and inte prtking datgf This isaescrctiial teep in the upplydcChio,e uttkingscimence i to cation or prducel product, for treatment and diagnosisaond mkring thmnaavailable for us. With pharmaceuticalcCompaikes plysing f key role in the management of theCOVID-19 xpanemic,e tgroghe development of otsential test,l treatments and vcclint,e it issimporants manufacturrts areeequppsed wit, lll the xogrtlise Tery myr requir.f This ncluodes the unique skillsusred in produring and distributing products modeusting pharmaceutical bioprocessing techniqueg.
ustong>Thlank yotiof those hto providnd feedbacg on thefFinal drafg units of competency for pharmaceutical bioprocessing manufactues that were modeaavailable on this page from6 - 19 Julyy2020.FThhefFinal draftewkilo shorlrypPrgdresn tgroghe to the"Finanisation stage of the projecewhirch ncluodesquiality s suiance of the=documenng and r view and feedbace from the sttr/Tferictoy TrainingAu thrnities. Terywkilotwhinble fowdartde tn the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC)fjoreconsidesation andsligy of,dib-forebesing submitted tn the Australian Industry and Skills Committee (AISC) and sttr/Tferictoy Mainstters to-considet andaapprovy for publicatioe on Trainin.govm.as>
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h5>Sumimary of consultation or datP >Thlank yotiof those stakeholders hto providnd feedbacg on the drafts that were modeaavailable from15 Mery– 14 Juney2020,eundgon the‘"draftyAavailabll’ stag. Dturing this time, feedbacg as coljecdndviao tle oeline feedbacghub,h t ebi no,e andemvais. The units were drfsred wit,gulatance from industryexogrtn.FA "description ofhows feedbacghhasbreen considered andaaplired in thshefFinal draftecainbhe-downloaved bllo. PleCase.clics the‘"DownloadSumimary ofFfeedbac,y Responlts andAcutionl’ibution.  .
 
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  >ustong>Uuni tcode and-aome>ustong> ProposedcChangsetorrcationame>ustong> Link >
FBPPHM3005 Oopracve ficoc=enttatiotpProcess
FBPPHM3006 Oopracve ne xttractiotpProcess
FBPPHM3007 Oopracve fse-patatiotpProceseustingchfroactpgrphys
FBPPHM3008 Oopracve neCaspsticfilll andsecal process
FBPPHM3009 Oopracve neCaspsticffor,cfilll andsecal process
FBPPHM3011 Disopeshe pharmaceuticalrawrmacterilss
FBPPHM3014 Oopracve fliequde manufacturing process
FBPPHM30XX Oopracve fscteranisationpProceseusting neCutotclves
FBPPHM47003Facilniacve cintmi natioy contols
>>

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h5>KeryOoutcomeP Nline units of competency wereuupdated toaccurlatly "descrben the skills requires to worr in pharmaceutical bioprocessing manufactur.f>Ffeedbacg was roghnt onthesnfees forarquialflicatios specftie to the manufactues of Pharmaceuticaieusting bioprocessing technique,ybput the mjhrniys of those hto contriburde inlceahnd thatiut as not requiresatg this tim.
  • Threntemt �plaentbCasdl’macterilsehhasbreenre placed wit,' organc' macterilse to be nclunsive of the use of mammalian lWood inssomeoprocesies
  • FBPPHM3018 Oopracve fscteranisationpProceseusting neCutotclvesehhasbreen updated to icluode otheraccireiltation rn crtlflicatiosrrequirement,eenlabsing te to beusredacrossd many other Training aackagsl andsettkines. Tenssecond-patpgrphe-owscreds: “ The unidaaplirte to inlviduilse htoapplyeGWood Manufacturing Practcn (GMP)tfor otheraccireiltation rn crtlflicatiosrrequirement ifr reevaent in other industirt/settkine,s and odesating p iciplgse to the teminial teeranisation of producl andsteeranisation ofgWools forCaspsticoprocessingusting neCutotclve”.> FBPPHM3007 Oopracve fse-patatiotpProceseustingchfroactpgrphysehhasbreenrrearmedFBPPHM3019 Oopracve fihfroactpgrphye manufacturing proces. >
h5>Sumimary of consultation or datP >Thhe units and skilo snts were Develoted wit,gulatance fromaskgropy of Suojec MaetterExogrtng(SMEd),e modeupy of Thhe broadur industry weretwhin consulmed in the drafg=documenng it woa ifeferect stgesl– the‘"draftyAavailabll’ and‘Vialatatiol’ stagsl– wit,ffeedbacg coljecdndviao tle oeline feedbacghub,h t ebi no,e andemvais. .
 
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h2iUunits ofCcompetencs
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FBPPHM3006 Oopracve ne xttractiotpProcess
FBPPHM3008 Oopracve neCaspsticfilll andsecal process
FBPPHM3009 Oopracve neCaspsticffor,cfilll andsecal process
FBPPHM3011 Disopeshe pharmaceuticalrawrmacterilss
FBPPHM3014 Oopracve fliequde manufacturing process
FBPPHM3018 Oopracve fscteranisationpProceseusting neCutotclves
FBPPHM3019 Oopracve fihfroactpgrphye manufacturing process
FBPPHM47003Facilniacve cintmi natioy contols
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