DEPARTMENT OF PHARM
ACY
UNIVERSI
TY OF MA
LTA
FEASIBILITY OF A LABORATORY SETUP FOR
BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
Nathaniel Farrugia, Anthony Serracino-Inglott, Lilian M. Azzopardi
Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
nathaniel.farrugia.09@um.edu.mt
Department of Pharmacy
University of Malta
INTRODUCTION
AIMS
The Maltese islands are a hub for various world class
 To create a lab setup, operating under GLP, equipped to carry
1
pharmaceutical companies specializing in the production of
generic drugs. Since bioequivalence to the originator product is
out bioequivalence studies
the determining factor in the production of generics, the
 To validate relevant methods using sample APIs
necessity for and the feasibility of setting up a local independent
 To determine the feasibility of the lab, servicing the local
2,3
facility dedicated to carrying out bioequivalence testing was
industry
investigated.
METHOD
General Laboratory Design
LCMS Method Validation
 A site to house the lab was
 LCMS
 Laboratory designed according to
 Quotations for equipment, furniture
 Human blood plasma obtained from
and materials were requested from
both local and foreign suppliers
the Malta blood transfusion clinic
was spiked using the APIs
amlodipine,
rosuvastatin
and
hydrochlorothiazide
GLP and BS/EN standards
 Consultation meetings were held
with architect to design
blueprint reflecting GLP
from
methods chosen
literature were validated
identified - the new Life Sciences
Park
a lab
 SOPs were created for all equipment
and processes required in the lab
 3D renderings were created to
Feasibility Assessment
better visualize the lab
 Meetings
were
held
with
pharmaceutical companies and
regulatory authorities to establish
local scenario
 Costing
exercise performed
determine cost per analysis
to
RESULTS
A laboratory blueprint was designed around an area of 145m
2
and sections for furniture, equipment and safety features as
well as for sample storage, preparation and analysis were
allocated, following GLP and BS/EN standards (see Fig 1)
10 SOPs were created:
Ordering and payment of
goods
Receipt and storage of
Disposal of hazardous waste
Standard solution preparation
Calibration and operation of
LC-MS
Calibration of balances and
pipettes
Sample preparation
Calibration and operation of
centrifuge
Extraction of plasma from
whole blood
Mobile phase analysis
Fig 1. Blueprint and 3D rendering of Lab using Revit® 2014
OPERATING EXPENSES
EUR 131,000 Yearly
Out of the 8 companies interviewed, all manufacture generics
and all outsource biostudies to laboratories in India. None of
the companies saw the usefulness of outsourcing to a local
bioequivalence lab. However 5 of the companies showed
interest in outsourcing niche pharmacopoeial tests to local
laboratories if available
Capital Expenses and Operating Expenses for the lab were
CAPITAL EXPENSES
EUR 254,000
Materials
EUR 27,000
Rent of premises EUR 25,000
Salaries
EUR 79,000
Equipment
EUR 219,000
Furniture
EUR 35,000
Total Cost*
EUR 385,000
*Set-up cost and first year
Cost per sample analysed
EUR 32.50
determined, allowing the cost per sample analysed to be
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worked out using the Product Pricing Formula (see Fig 2)
Fig 2. Capital Expenses, Operating Expenses and Cost per Sample Analysed
CONCLUSION
Theoretically the setup of the bioequivalence laboratory is feasible. However, since bioequivalence studies are not performed by
pharmaceutical companies locally, but rather outsourced to laboratories in India, the feasibility of the lab is outweighed, unless; there is
an injection of foreign investment to develop novel generics locally through R&D. Considering the feedback given by most of the
companies interviewed, a laboratory that caters for contract analysis of niche tests, such as Palladium testing and X-Ray Diffraction
analysis, remains the most feasible alternative in order to satisfy the needs of the local industry and improve Malta’s attractiveness
towards foreign investors in the industry .
References
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2.
3.
4.
KPMG. Malta: The hub for world-class Pharmaceutical Companies. KPMG: Malta; 2011
Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology, 2013;14:1.
EMEA. Committee for medicinal products for human use. Guideline on the investigation of bioequivalence. EMEA: London; 2010
Tarbit I F. Laboratory costing system based on number and type of test: its association with Welcan workload measurement system. J. Clin. Pathol 1990;43:92-97