1. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
Biopharmaceutical Development Capabilities and EMEA Approved
cGMP Manufacturing at Medipolis GMP, Oulu, Finland
By
MEDIPOLIS GMP Ltd
Kiviharjunlenkki 2, 90220
Oulu, Finland
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2. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
Medipolis GMP
Medipolis GMP is a Finnish CMO and a Process Development and Optimization
group specialized in..
-cGMP production with microbial fermentation,
-Cell culture based process development,
-CHO expression systems for Full length Monoclonal Antibody and
-Process development services for biopharmaceutical companies.
Our mission is to add value for our customers to bring their products to the market fast and
cost efficiently by offering reliable partnership in manufacturing.
We see ourselves as an converter between the lab bench scale and commercial production ie.
To change the process from lab scale to industrial form.
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3. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
Medipolis GMP Finland
• Specialized in microbial fermentation
• Focused in small scale production of bulk
material (API) for toxicological and clinical
production; therapeutic proteins,enzymes,
therapeutic vaccines,plasmid DNA, etc.
•Process Development and optimization
Capabilities in cell culture expressions of Full
length Monoclonal Antibody (Mabs)and their
Fragments
• Process development and scale up services
• Excellent network for fill and finnish and large
scale production
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4. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
FACILITY
• Built for biopharmaceutical production in 2000-
2001
•23000 Square Feet/ 4000 Square Feet clean room
• Meets FDA and EMEA requirements for
biopharmaceutical manufacturing
• Inspected by and license from NAM ( Finnish
EMEA Authority)
Production area in A/B, C and D classes *
• Bio safety level BL 3
* Clean Room Classification:
A= 100 particles per sq ft ,
B = 1000 particles per sq ft ,
C = 10 000 particles per sq ft and
D = 100000 particles in q ft. s
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5. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
GMP FACILITY
• 3 floor building: base floor for clean utilities, maintenance,
warehousing, liquid waste treatment, mid floor for clean room, in
process and analytical laboratory, washing rooms ( in Class D) and
top floor for HVAC
• One fermentation suite in class C
• Harvesting suite in Class C
• Purification suite in Class C, temperature of one of the rooms can be
lowered to +4 C
• Dedicated buffer and media preparation area, Class C,
• Lyopholization and final filtration in A / B area
• 5 HVAC units for the clean room
• Continuous waste contamination for liquid waste and
decontamination autoclave for solid waste
• BL 3 capability and technical readiness
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6. Clean Room Facilities
COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
•Dedicated facility designed and built
for Biopharmaceutical Production
•23000 Square feet total area / 4000
square feet clean room area
•Class A/B, C and D
•BL 3
•FDA and EU compliant
•Production License granted by
Finnish National Agency of Medicine
•Regularly inspected by NAM
•Trained and Experienced Personnel
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7. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
Microbial expression systems
• E.coli, cGMP manufacturing and process
development experience
• Pichia, very strong process development and
production experience
• Bacillus subtilis, strong cGMP manufacturing
experience
• CHO Expression system for Full Length
Anticancer Monoclonal Antibody Expressions
• SCFv Development as a part of EU project to
use as Biomarkers Etc.
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8. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
MAIN USP AND DSP EQUIPMENT IN GMP
• 2 X 15 liter , 1 x 150 liter and 1 x 750 liter fermentors ( B.Brown)
• Homogenizers ( APV)
• Centrifuges, both continuous and batch ( Westfalia, Beckham)
• 2 Tangential Flow Filtration Units ( Sartoflow)
• 3 Chromatographic units ( GE-Healthcare)
• Protein crystallizer ( Custom made)
• Lyophilization unit ( Tellstar)
We also very commonly use disposables that gives us flexibility
Process Development Laboratory
• 2 X 10 liter fermentors
• 2 x 15 liter fermentors
• Downstream equipment
• Basic analytical equipment
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9. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
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14. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
Main analytical equipment in GMP:
•HPLC (Agilent 1100)
•GC (Agilent 6890)
•CE (Hewlett Packard 3D CE)
•Polarimeter (Jasco P-1020)
•UV/ Vis Spectrophotometer
(Shimadzu UV-2401 PC, temperature controlled)
•TOC Analyzer (Shimadzu TOC-5000A)
•Microplate/ELISA Reader (Labsystems iEMS Reader MF)
•Melting point apparatus (Buchi B-545)
•Mettler Toledo titrators DL53 and DL38 (KF)
•Mettler Toledo refractometer RE40D
•FT-IR Spectrometer (Perkin Elmer Spectrum One)
•pH-meters,
• SDS-PAGE,
•TLC,
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15. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
SERVICES FROM GENE TO CLINICAL
Medipolis GMP offers both process development services and produces GLP material
for preclinical studies and GMP material for clinical phase I to II trials
• Development of expression systems starting from gene
• Process development
• Production of preclinical material
• Technology transfer
• cGMP production
– Fermentation
– Downstream
• Analytical services
• Freeze drying
• GMP documentation
• QA / QC Support
• GMP consulting
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16. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
TRACK RECORD
• Produced the largest amount of recombinant therapeutic
protein in Finland
• Produced successfully material for clinical phase II trials for
biopharmaceutical companies for Finnish and international
clients
• Manufacturing license upgraded for commercial production
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17. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
PERSONNELL
• 19 Employees
– 6 in Process Development and Optimzation
– 5 in QA / QC
– 8 in production and process development
• 1 PhD in Biosciences and Biotechnology, 2 Tech. Lic. in bio
processing, 4 M.Sc. in organic chemistry, bioprocess
engineering etc, B.Sc in pharmacy, bioprocess engineering, Lab
technicians etc.
• More than 100 years experience in pharmaceutical industry (
commercial production ) and over 50 years in modern biotech
• Personnel has strong industrial experience in cGMP
manufacturing, QA/QC and regulatory affairs
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18. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
CUSTOMER BENEFITS
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19. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT
THANK YOU for your Attention.
For Further Details Please contact-
Dr. Ashesh Kumar
Director- Biopharmaceuticals
Medipolis GMP Oy
Kiviharjunlenkki 2, Oulu
Finland
Kumar.ashesh@medipolisgmp.com
Phone- 358-400207380.
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