The  Catapult  Programme:  A  network  of  world-­‐leading  centres  designed  to  transform  the  UK’s  capability  for  innova<on  

in  specific  areas  and  help  drive  future  economic  growth.    

•  Sharon  Brownlow,  Head  of  Collabora:ons  •  Sharon.brownlow@ct.catapult,org.uk  •  07891  294611  

Our  Project  idea  

•     Development  of  innova<ve  ATMP  manufacturing  processes  /  analy<cs  •   Transla<on  to  GMP  manufacture  •   Poten<al  development  of  novel  GMP  manufacturing  processes  suitable  to  exploit  a  mul<-­‐collaborator  facility        

What’s  innova:ve  about  it?  •   No  UK  company  has  succeeded  with  truly  large  scale  GMP  manufacture  of  cell  therapies    • There  are  numerous  manufacturing  hurdles  to  overcome  for  large  scale  GMP  vector  manufacture  –  both  process  &  analy<cal  • Systems  do  not  exist  enabling  high  quality  (late  stage  clinical  /  commercial)  ATMP  manufacture  in  mul<-­‐collaborator  shared  GMP  facili<es      

 The  services  we  can  offer?  

•   PD,  AD,  HEMA,  regulatory  advice,  tech  transfer  •   Facili<es  &  support  for  YOUR  GMP  manufacture,  inc.  assay  valida<on,  QC  support,  QP  services,  GMP  operator  training            

 

The  partners/services  we  seek?  

•   ATMP  developers  looking  to  establish  /  upscale  their  own  GMP  manufacture  in  the  UK  and  work  with  us  to  create  the  required  innova<ve  manufacturing  strategies  to  ensure  eventual  commercial  success    

• Technology  /  supply  chain  companies  with  solu<ons  to  the  boWlenecks  &  challenges    

 

Reading School of PharmacyDr Al Edwards (Associate Professor in Biomedical Technology)

a.d.edwards@reading.ac.ukwww.reading.ac.uk/pharmacy

About us •  Research  in  all  aspects  of  Medicines  Manufacture  •  Experienced  R&D  partner  in  Knowledge  Transfer  •  Many  experts  who  contribute  to  UK  Medicines  Manufacture  •  Range  from  drug  structure  up  to  pa<ent  (and  even  typography)  •  Mul<ple  condi<ons  including  vaccines/biologics,  neuropharmacology,  cardiovascular  •  Work  with  new  startups  up  to  biggest  Pharma;  new  IP  discovery  to  contract  research  

What we can offer•  Expert-supervised instrumentation•  Synthesis and biosynthesis•  Preclinical models up to LlamaWhat’s our innovation/idea•  Examples of expertise:•  From molecules: design, produce,

formulate, analyse, model: small molecule/ polymer/ protein/ carbohydrate/ nucleic acid

• … to neuro and cardiovascular…• … to patients and computers…

What or who we are seeking•  New industry partners•  Broad range of projects•  Anything from Discovery…•  … to Development and Adoption.

What’s the market opportunity we are addressing•  What is your market?•  Research and Development

partnering•  Flexible approach to IP

LucideonDr Gilda Gasparini, Chemical EngineerGilda.gasparini@lucideon.com01782 764428| www.lucideon.comAbout us •  SME  based  in  Stoke-­‐On-­‐Trent  •  Development  and  Commercialisa<on  company  •  Service  and  exper<se:  

•  Materials  and  Process  consultancy  •  Tes<ng  and  Characterisa<on  •  Internal  R&D  crea<ng  IP  and  licence  /  royal<es  sales  

What we can offer•  Experimental work (lab and scale

up)•  Testing and characterisation•  Project management

What’s our innovation/idea•  iCRT – inorganic controlled

release technology•  Scale up•  Abuse deterrence / API

protection / solubility enhancer

What or who we are seeking•  End users•  Technology partners•  Equipment suppliers

What’s the market opportunity we are addressing•  Abuse deterrent market•  Low solubility market•  Plastic microbeads replacement

‘Centre for Manufacturability Design’Martin Jones/John Stanfordmartin.f.jones@astrazeneca.com/j.stanford@leeds.ac.uk0113 343 2402| www.leeds.ac.ukAbout us •  AstraZeneca  Macclesfield  and  The  University  of  Leeds  •  Partnered  as  CENTRE  FOR  MANUFACTURABILITY  DESIGN  (CMD)  •  AZ  is  largest  UK  Pharma  Produc<on  Facility  •  University  of  Leeds  is  a  top  ten  UK  research  power  with  World  Class  Capabili<es  for  MOLECULES  TO  MANUFACTURING:  

•  Par<cle  Science  •  Materials  Func<onality  and  Characterisa<on  •  Manufacturing  Produc<vity  and  Consistency  

What we can offer•  Advanced physical understanding of

Manufacturability Problems- (eg) Your material is in spec…- BUT IT DOESN’T WORK! WHY!!??- Agglomeration? Triboelectric charging?

What’s our innovation/idea•  We do not understand sufficiently the physical

properties of our materials and how they relate to processing

•  CMD will create fundamental understanding of physical properties of particles and materials and translate to control of macroscopic behaviours – ‘Manufacturability’

•  Process Technology innovation is not complete without physical material/particle understanding and control – ‘small’ and ‘large’ molecules

What or who we are seeking•  More manufacturers to join the

CMD•  Instrument/device companies to work with

CMD to translate Manufacturability techniques into industry

•  Partnership with other Pharma/ technology agencies to extend the reach of CMD

What’s the market opportunity we are addressing•  Poor productivity in secondary processing

costs £billions in failures, reworks, rectifications and issue management

•  Novel analytical/characterisation tools & services

Pathway  Biopharma.    •  Pathway  biopharma  was  formed  to  guide  early  stage  companies  throughthe  biologics  development  pathway.  

•  Both  partners,  myself  Jon  Dempsey  and  Malcolm  Rhodes  have  manyyears’  experience  in  the  development  and  

manufacture  of  biologicmedicines.  

•  Our  main  focus  is  suppor<ng  CMC  programmes  for  early  stage  productsleading  to  the  prepara<on  of  the  first  clinical  

batch.  We  can  assist  with  theevalua<on  and  development  of  recombinant  proteins,  cell  therapies,  andan<body  drug  

conjugates.  

•  We  can  provide  grant  wri<ng  and  review  support,  early  stage  productevalua<on  and  also  act  as  a  partner  on  applica<ons  

for  all  aspects  of  CMCincluding  project  management  and  technical  support  and  advice.  

•  We  are  looking  to  partner  with  academics  or  early  stage  industrialcompanies  to  accelerate  their  products  to  the  clinic.  

University of SheffieldMimoun Azzouz, Professor m.azzouz@sheffield.ac.uk01142222238|http://sitran.dept.shef.ac.uk/people/azzouz/About us •  Gene  therapeu<cs  for  neurodegenera<ve  diseases  •  AAV  vector  design  •  AAV  vector  produc<on  •  Pre-­‐clinical  disease  models  •  Gene  therapy  clinical  development  

•  .  •  .  

What we can offer•  Experience in working hands-on with AAV and lentiviral at research

scale

•  Experience of the preclinical stages of gene therapy development

•  Experience in gene therapeutics clinical development; i.e. GLP Tox/safety studies with CROs, interaction with GMP manufacturing CMOs, preparation and submission of briefing documents for scientific advise meetings with MHRA, Advisor for companies and foundations focusing on clinical development of gene therapeutics.

•  Discovery and translational research at SITraN and BRC Translational Neuroscience

What’s our innovation/idea•  GMP manufacturing facility in the North•  Gene therapeutics for monogenic diseases

What or who we are seeking•  Partners in GMP manufacturing

•  Partners to develop new manufacturing protocols

•  Partners for clinical development

•  Sensor systems for vector production

What’s the market opportunity we are addressing•  GMP manufacturing of viral vectors•  Gene therapeutics for monogenic disorders

Centre for Process Innovation (CPI)Kirsty McLachlan, Bid/Proposal Development Managerkirsty.mclachlan@uk-cpi.com01325 376 802 | https://www.uk-cpi.com/

About us •  CPI,  part  of  the  High  Value  Manufacturing  Catapult  

•  A  not-­‐for-­‐profit  research  organisa<on  whose  purpose  is  to  enable  innova<ve  companies  develop  their  ideas  and  inven<ons  to  succeed  commercially  

•  Work  across  5  Business  Units  –  Biologics,  Formula<on,  Printable  Electronics,  Industrial  Biotechnology  &  Biorefining  and  Healthcare  Photonics  

•  We  are  a  Research  Technology  Organisa<on  providing:  

•  Exper<se  –  Industrially  experienced  staff  

•  Facili<es  –  Open  access  state-­‐of-­‐the  art  

•  Funding  –  SME  support  and  Collabora<ve  research  

MAMMALIAN  AND  MICROBIAL  EXPRESSION  

of  proteins,  aWenuated  viruses,  nucleic  acids,  and  complex  nanopharmaceu<cals  

DEVELOPMENT  AND  OPTIMISATION    

of  innova<ve  processes  and  technologies  

NEW  AND  IMPROVED  ANALYTICAL  METHODS    

for  product  and  process  characterisa<on  

HIGH  THROUGHPUT,  SCALE  DOWN  PROCESS  DEVELOPMENT  

TECHNOLOGY  DEMONSTRATION,  BENCHMARKING  AND  SCALE  UP  

BUSINESS,  IP  LANDSCAPING,  BID  WRITING  AND  COMMERCIALISATION  SUPPORT  

What we can offer•  At Biologics:

Pharma Related Activities at Formulation

Complex  Medicines  

•  Manufacture  /  scale-­‐up  of  micro/nanopar<culates  •  Flexible  design  and  characterisa<on  •  Microsun:  building  new  capability  in  scale-­‐up  via  

microfluidics  (Jan  2018  start)  

Oral  Solid  Dosage  Forms  

•  Support new product & process development •  Supporting the implementation of modelling

approaches in industry •  Demonstrating the value of improved materials /

excipients •  Defining control strategies for commercial

manufacturing processes •  Assessing new and existing process analytical tools in

real-life manufacturing

PAT-­‐enabled  process  development  and  mechanis<c  modelling  

NFC  focus  on  technology  agnos<c  finished  product  manufacture,  partnering  with  the  experts  in  the  relevant  fields  

Underpinned  by  a  philosophy  of  learning  small,  fast  and  thoroughly  through  applica<on  of  informa<cs