axis-shield diagnostics ltd. pips studentships jeff brady
TRANSCRIPT
AXIS-SHIELD DIAGNOSTICS LTD.
PIPS STUDENTSHIPS
JEFF BRADY
Summary• Why Axis-Shield is a good place for the students• Why student placements are good for Axis-Shield• Questions / Discussion
Axis-Shield Diagnostics Ltd. – Key Focus
Identify, develop and commercialise in-vitro diagnostic
tests
Using our World class
facility with our world class
teams
Producing World class Products – ‘Changing lives’
Axis-Shield Diagnostics Ltd. - Dundee
Axis-Shield Diagnostics Ltd. – Our History
Pre Merg
er
• 1982 – Shield Immunologicals formed by Scientists spinning out of Dundee University • 1984 – Axis Biochemical created from spin out of Oslo University • 1987 – Shield Immunologicals renamed Shield Diagnostics following capital investment• 1993 – Shield Diagnostics listed on London Stock Exchange• 1998 – Move to current building – 100 employees
Early Merg
er
• 1999 - Merger of Axis Biochemicals ASA (Norway) and Shield Diagnostics Ltd (Scotland)
• 2003 – AxSYM xtra licence deal signed & Autoimmune range divested
• 2004 – Laboratory Division consolidated in Dundee
Current
• 2010 – Enzymatic Homocysteine technology acquired from Catch Inc.
• 2011 – Acquired by Alere Inc.
Axis-Shield Diagnostics Ltd. – Our Key Partners
Partner since 1997• 20 + product launches• Multiple Systems (IMx, AxSYM & ARCHITECT)
Partner since 2001• Homocysteine on BNII – launched 2005• Centaur agreements - Anti-CCP -2011/ Active B12 - 2013
Partner since 2009• Anti-CCP clinical chemistry• Enzymatic Homocysteine
Axis-Shield Diagnostics Ltd. – Key Products
Vitamin B12 DeficiencyActive B12 - improved diagnosis of vitamin b12 deficiency in at risk groups e.g. Elderly
DiabetesHbA1c - Diabetes
diagnosis and monitoring of
glycemic (or glucose) control
Rheumatoid ArthritisAnti-CCP - RA patient stratification for early
therapeutic intervention
Severe SepsisHeparin Binding Protein – Identify patients who will progress to severe illness in infection related conditions
CardiovascularHomocysteine - key risk factor determination
Laboratory Division – Product Pipeline
45329880
Practical (laboratory and Clinical) ‘Proof-of-Concept’
work being undertaken
Undergoing detailed
non-practical assessment (including IP)
Markers reviewed and rejected
Potential markers identified
45329880
Practical (laboratory and Clinical) ‘Proof-of-Concept’
work being undertaken
Undergoing detailed
non-practical assessment (including IP)
Markers reviewed and rejected
Potential markers identified
Axis-Shield Laboratory Division– Product Pipeline
Laboratory Division – Our People 137 people Onsite
Average length of service is 8.5 years. 48% have been with the company for over 10
years of which a further 14% over 20 years service
55% of our employees have a first level degree or higher.
Axis-Shield Diagnostics Ltd. – Our People
R&D Structure
Axis-Shield Diagnostics Ltd. – Operations
Reagents –Protein purification & conjugation
Technical Manuf. Bulk manufacture & test (SPC), solid phase coating
Filling - Fully Automated fill lines with built in full IPC
Kit Packing & Label –Label Vision inspection system
Support –
Supply chain
Technical support incl. technical transfer
C.I.Site wide 5sCI Coach Training
World
Class
Produc
ts
•5 Patented Products (HcY, Anti-CCP, Active B12, HbA1c & HBP)•Excellent on market product quality & delivery performance
World
Class
Facility
•Compliant Quality System that fosters a culture of continuous improvement•Continuous improvement embedded in the culture e.g. 5s maintained site wide
World
Class
People
•Experienced & Knowledgeable Staff with •30 years research & development •20 years working with major OEM’s•19 years production transfer
Axis-Shield Diagnostics Ltd. – Summary
PIPS Project On-Market Group• As working on “On-Market” products (FDA approved)
• high burden of proof• Bureaucratically, difficult to change
• 3 months; must be compact• Student needs to be independent (supervision time limited)
• Lab work• Experimental planning• Experimental analysis• Write-up
PIPS project• Improved in-house assay for S-adenosyl
homocysteine lyase
L-Hcy Adenosine
SAHase
SAH
+ + H2O
Good, basic biochemistry
Vmax = 0.020034 dA min-1
Km = 0.1673mM
[Substrate]~ 10x Km value. ∴ between 1- 2mM
0 2 4 6 8 10 12 14 160
100
200
300
400
500
600
700
800
f(x) = 49.9163858975139 x + 8.3486278981178R² = 0.999756279291766
[S][S
]/v
3 replicates for each data point!
PIPS project
• Took R&D model for assay• Feasibility• Optimisation• Validation
Robust Design approachUnderstand key design requirements
Risk Assess methods and formulations to capture key variables
Perform DoEs to optimise/characterise parameters
Experimental design training• Training given by our stats department• Advantages over One Factor At a Time (OFAT)
experiments• Stats input to experimental design and interpretation
CurHigh
Low0.74787D
Optimal
d = 0.74787
Minimum%CV
y = 2.0085
0.74787DesirabilityComposite
0.020
0.060
0.050
0.150µParts(%Conj (µg
[0.0995] [0.0576]
DOE Robustness Experiments
Variables tested:• Temperature• [Substrate]• [DTNB]• pH
Conclusions:• No variables significantly influence output• Conditions for assay set at
37oC pH 8.5 1.2mM SAH 12mM DTNB
Summary- what we got• Ciaran -excellent contribution to SAH-ase assay
project• Achieved goals for project• Assay passed to Reagents for implementation• Report written• Presentation to senior managers
• Additional support to us for protein engineering aspects (ASD opportunity)• Suggested codon optimisation• Helped with SNP project
Summary what Ciaran got• Especially crafted induction process
• GMP• Rigorous recording of experiments (SOP driven)
• Exposure to Experimental design driven experimentation• Input from Quality Engineers etc.
• Participation in Social events• Gin tasting !• Beer festival !