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The Masters in Biomanufacturing Newsletter




͞Where  Biomanufacturing  Meets  Business͟   WƌŽĨĞƐƐŝŽŶĂů^ĐŝĞŶĐĞDĂƐƚĞƌ͛ƐWƌŽŐƌĂŵĂƚNorth  Carolina  State  University    

Biomanufacturing  Training  and  Education  Center  (BTEC),  Centennial  Campus  

  Newsletter  Vol.  1,  Summer  2011  ʹ  


Greetings  from  BTEC  

This   is   the   first   of   a   tri-­‐annual   newsletter   from   North   Carolina   ^ƚĂƚĞ hŶŝǀĞƌƐŝƚLJ͛Ɛ   (NCSU)   Masters   in   Biomanufacturing   (BIOM)   program.     This   letter   is   sent   to   BTEC   friends   and   colleagues   in   the   field   of   biomanufacturing   and   biopharmaceuticals   to   keep   them  informed  of  updates,  changes,  and  the  latest  happenings   at  this  exceptional  new  program.   The   BIOM   program   is   a   rigorous,   44-­‐hour   Professional   Science   DĂƐƚĞƌ͛Ɛ(PSM)  program  focused  on  cross-­‐training  individuals  in   advanced  scientific  biomanufacturing  theory  as  well  as  business   knowledge   in   bioscience   management.   The   BIOM   program   is   based   out   of   the   82,500   gross-­‐square-­‐foot,   $50   million   Biomanufacturing  Training  and  Education  Center  (BTEC)  located   ŽŶ E^h͛Ɛ ĞŶƚĞŶŶŝĂů ĂŵƉƵƐ͘   BTEC,   completed   in   2007,   is   a   simulated  cGMP   facility  offering  industry-­‐scale,   state-­‐of-­‐the-­‐art   equipment   to   train   students   and   is   the   only   training   and   education  facility  of  its  kind.   The   BIOM   program   was   made   possible   due   to   a   3-­‐year,   $700,000   grant   from   the   National   Science   Foundation.   NCSU   ǁĂƐŽŶĞŽĨϮϭƵŶŝǀĞƌƐŝƚŝĞƐĂǁĂƌĚĞĚĂ^ĐŝĞŶĐĞDĂƐƚĞƌ͛ƐWƌŽŐƌĂŵ grant  out  of  more  than  200  applicants  from  around  the  nation.  


The  Masters  in  Biomanufacturing  Program  

The   BIOM   PSM   program   is   a   new   kind   of   degree   that   develops   ƚŽŵŽƌƌŽǁ͛Ɛ ůĞĂĚĞƌƐ ďLJ ĐƌŽƐƐ-­‐training   individuals   in   not   only   their   specific  scientific  discipline,  but  also  in  related    areas  of  management.   BIOM   students   will   take   a   number   of   specialized   courses   including   Global   Regulatory   Affairs,   Biopharmaceutical   Protein   Characterization,   Microbial   Biotechnology,   two   semesters   of   Industry   Practicum,   professional   skills   training,   a   required   industry   internship,   as   well   as   their  choice  of  focusing  on  either  upstream  or  downstream  processes.     Either   of   these   concentrations   will   require   small,   intermediate,   and   industry  scale    coursework.   Students   are   required   to   take   a   minimum   of   6   hours   of   MBA   coursework  if  they  are  on  a  thesis-­‐based  MS  track,  or  9  hours  of  MBA   coursework  if  they  are  completing  the  non-­‐thesis  MR  track.     In  both  cases  all  MBA  classes  are  taken   Ăƚ E^h͛Ɛ ŚŝŐŚůLJ ƌĞƐƉĞĐƚĞĚ :ĞŶŬŝŶƐ Graduate   School   of   Management   in   the  Poole  College  of  Management.  The   BIOM   program   requires   Project   Management   and   a   Strategic     Management  Foundations  course.     Applicants  come  from  a  wide  variety  of  disciplines  including  Chemical   Engineering,   Biological   and   Bioprocess   Engineering,   Life   Sciences,   Pharmaceutical   Sciences,   directly   from   industry,   and   other   undergraduate  and  graduate  programs.  


  CompleƚĞĚŝŶϮϬϬϳŽŶE^h͛ƐĞŶƚĞŶŶŝĂůĂŵƉƵƐ͕dŝƐĂŶϴϮ͕ϱϬϬŐross-­‐square-­‐foot   facility  dedicated  to  biomanufacturing  training  and  education.  It  is  a  simulated  cGMP  facility   and  the  only  one  of  its  kind.  

First  Class  now  in  Industry  Internships   The  first  class  of  BIOM  students  have  officially  completed  their   first   year!   Five   of   the   six   students   have   decided   on   the   downstream  processing  track  and  all  six  students  are  currently   working   in   their   industry   internships.   Hope   Metzler,   Juan   Ceuva,   and   Veronica   Adams   are   at   Biogen   Idec   in   Research   Triangle   Park   working   in   downstream   processing.   Sanaa   Elouafiq  is  at  Arbovax,  a  small  start-­‐up  company,  working  on  a   vaccine   for   Dengue   Fever.   Renee   Berry   is   working   in   granulation   at   Novozymes   and   Jane   Winkleman   continues   to   work  at  Eisai.     The   majority  of  the  class  and  laboratory  work  for  each  of   the     students   processing   tracks   were   completed   in   their   first   year.   MBA   courses   and   biomanufacturing   research   will   be   the   primary  focus  during  the  second  year  of  the  program.  Multiple   students  have  expressed  interest  in  obtaining  their  Biosciences   Management   MBA   at   the   Jenkins   School   of   Management   following   their   BIOM   graduation   and   those   students   will   therefore  also  be  enrolled  in  prerequisite  courses.   dŚŝƐ &Ăůů͛Ɛ  ϱϵϬ͗ /ŶĚƵƐƚƌLJ WƌĂcticum   in   Biomanufacturing   course   will   focus   on   the   production   of   Influenza   Vaccine.   The   case   study   will   require   students   to   visit   industry   facilities   and   fully   understand   regulatory   aspects   in   order   to   convert   BTEC   into  a  fully  functioning  vaccine  facility.        

  First  class  of  BIOM  

students.  Left  to  right:   Sanaa  Elouafiq,  Renee   Berry,  Veronica  Adams,   Hope  Metzler,  Jane   Winkleman,  and  Juan   Cueva  


Did  You  Know?  


Update  on  UNCGA  BIOM  Approval  

Since   the   inception   of   the   NCSU   Biomanufacturing   undergraduate   minor   3   years   ago,   BTEC   students   have   100%   placement   into   industry  or  advanced  education.     NCSU  was  voted  in  Kiplinger  Magazine  as  one  of   the  top  15  best  values  in  public  education.       Last   year,   BIOM   students   presented   final   projects  from  BEC  590:  Industry  Practicum  at  the   North  Carolina  Biotechnology  Center.  Located  in   Research   Triangle   Park,   it   the   oldest   biotechnology  center  in  the  U.S.   Less   than   4   years   after   opening   its   doors   BTEC   exceeded   its   goal   of   250   students   per   semester   target  enrollment  ʹ  an  annual  growth  rate  of  41   percent!  

The   BIOM   program   was   originally   expected   to   be   approved   by   the   University   of   North   Carolina   General   Administration   (UNCGA)   by   early   Spring  2011.  However,  due  to  the  retirement  of  President  Erskine  Bowles   in   early   2011   and   the   time   spent   searching   for   his   subsequent   replacement  in  Thomas  W.  Ross,  the  anticipated  approval  of  the  program   has  been  pushed  back.  It  currently  stands  that  BIOM  is  the  first  program   to  be  reviewed  in  the  new  fiscal  year  starting  July  1,  2011.  It  is  expected   that  BIOM  will  be  fully  accepted  by  Fall  2011.       Until  BIOM  is  officially  approved,  it  is  being  conducted  as  a  subset  of  the   highly   respected   Chemical   and   Biomolecular   Engineering   department.   Potential  students  interested  in  applying  for  the  program  should  apply  to   the  NCSU  Graduate  School  under  the  Chemical  EngineeringʹMR  program.    


>ŽŽŬŝŶŐƚŽƚŚĞ&ƵƚƵƌĞ͙   The  BIOM  program  will  grow  to  a  minimum  of  12   students  per  year  within  the  next  few  years.  BTEC   faculty   understand   that   many   of   our   future   students   will   come   from   an   industry   setting   and   will  likely  be  enrolled  as  part  time  students.    


In   order   to   better   accommodate   working   professionals,   BTEC   is   already   in   the   process   of   moving  as  many  classes  as  possible  to  outside-­‐of-­‐ work  hours.    This  coming  Fall,  two  courses  will  be   offered   in   the   evening   and   one   class   will   be   offered  online.    

Students  learning  the  Column  Chromatography  techniques  in  BTEC  Purification  Suite      

Graduate  Minor  Approved   Although   the   BIOM   program   is   still   awaiting   final   approval   from   the   UNCGA,   the   Graduate   Minor   in   Biomanufacturing   has   been   officially   approved.    ͞This  is  a  tremendous  step  forward  for  the  graduate  program   as   a   whole   and   now   allows   students   from   other   programs   to   gain   valuable  knowledge  and  hands-­‐on  experience  at  BTEC͟ƐĂLJƐŚƌŝƐ^ŵŝƚŚ͕ Program  Coordinator  for  the  BIOM  program.     For  both  Masters  and  Ph.D.  Candidates,  the  graduate  minor  will  require   2  credit  hours  of  biomanufacturing  research.  The  remaining  credit  hours   are   elective   classes   to   be   chosen   by   the   student.   Although   not   a   requirement,   we   recommend   students   complete   a   FDA   Regulatory   Compliance   course   and   an   upstream   or   a   downstream   track.   Like   the   BIOM  program,  a  complete  track  includes  small,  intermediate,  industry-­‐ scale  process  development  and  cGMP  operations  courses.      


Keeping  up  with  Industry  

BTEC   is   dedicated   to   keeping   up   with   the   latest   trends  in  biomanufacturing.  In  order  to  make  sure   students   are   receiving   the   most   up-­‐to-­‐date   knowledge   possible,   BTEC     keeps   close   ties   with   industry  personnel    by  holding  frequent  meetings   with   the   BTEC   Advisory   Board.   The   companies   represented  in  the  Advisory  Board  include:    

Graduate   students   planning   to   obtain   the   Graduate   Minor   in   Biomanufacturing   would  include  individuals  from  Chemical   Engineering,   Microbial   Biotechnology,     Microbiology,   Food   Science   and   Physiology.   The   minimum   credit   hours   for   Masters   students   is   10,   while   the   minimum  required  credit  hours  for  Ph.D.  students  is  12.    










More  information  on  BIOM,  contact:     Chris  Smith,  Program  Coordinator   Phone:  (919)  513-­‐2195