REPORT OF CONSULTANT

REGARDING
FMD VACCINEPRODUCTION
AT FMDRC, LAHORE
16-21 FEB. 2017
 Development of National Control Program for
FMD in Pakistan (TCP/PAK/3503)

OBJECTIVES
 Assessment of the current FMD vaccine production
process at FMDRC.
 Advise possible improvements of quality of the vaccine.
 Design a plan to increase and improve future production
and quality of the vaccine.
 Help Pakistan in completing stage-3 of the FMD-PCP
(Progressive Control Pathway for FMD control, OIE/FAO
Joint Tool).
 ASSESSMENT REPORT
1. General Vaccine Manufacturing process

Observations Recommendations

1. The current vaccine 1. Large scale production

process can be described as may be considered, build
very basic and not suitable new high containment
for large scale FMD vaccine production facilities in line
production with International standards
 2. BIO CONTAINMENT
Observations
Bio containment of the
current facility is completely
lacking e.g. entrance
procedure, bio safety
instructions, gowning change
procedure, air handling,
separation of activities :– Cell
production and Virus
production
Recommendations
The bio containment level of
the facility should be drastically
increased.
 SOPs and working procedures
should be developed.
Develop a bio security
procedure and a policy for
restriction of animal contact after
visiting and / or working in the lab
with FMD virus.
 Vaccinate all susceptible
animals in an area of 5-10 Km
around the F&MDRC in order to
build up a buffer zone.
 3. VIRUS INACTIVATION PROCESS
Observations
1. Currently 1 m Mol BEI and
0.04% formalin is being used
2. No in-activation control
performed
3. No-inactivation kinetics
4. BEI is prepared in open
vessel
Recommendations
1. In-activation with 3mMol
BEI and no Formalin
2. Implement in-activation
control (OIE)
3. Implement in-activation
kinetics (OIE)
4. Prepared BEI in closed
container or in fume hood
 4. Vaccine Efficacy & Batch Potency Test
Observations Recommendations
1. General proof of 1. Vaccinate 10 sero negative
efficacy by serology data animals
is missing 2. Perform vaccination serology
2. Batch potency testing testing on negative animals (day
of each batch is not 0, day 28).
applied. 3. Test sera by ELISA and virus
3. No antigen neutralization test
concentration step is 4. Developed and implement
performed. 146s test system.
5. Develop concentration
method
6. Implement batch potency test
on every batch.
 5. Quality Control Testing of FMD Vaccine or
Quality Assurance

Observations Recommendations

1. In process quality control 1. Use of 146s to assess the

(IPQC) is limited to sterility
testing and TCID50 testing.
2. Final product testing is
limited to sterility test and
safety test in mice.
antigen mass be carried out
during the IPQC.
2.Potency testing (challenge
method) should be carried
out.
 6. TRAINING PROGRAMMES
Observations
1. Training on all aspects of
FMD vaccine production is
lacking.
Recommendations
1. Extensive training on all
aspects of FMD virus and
vaccine manufacturing
should be arranged to all
personnel preferably at
some large vaccine
manufacturing facility.
2. Regular future guidance
and advise by a FMD expert
be organized for FMDRC
personnel's.
 7. FOCUS OF NEXT VISIT
Tasks Trainees
1. In-activation Dr. Sajjad Hussain, APVO, A-type Section
process and its Dr. Farooq Yousaf, VO, Section A-Type
Kinetics Dr. Agha Asaad Nayyer, SVO I/C O-Type
Dr. Ayesha Rana, VO, Section O-Type
Dr. Shaukat Ali, SVO, I/C Asia-I
Dr. Abdul Wahab, VO, Asia-I Section
2. Bio Containment Dr. Sajjad Hussain, APVO / Additional
Procedures Director
Dr. Agha Asaad Nayyer, SVO I/C O-Type
Dr. Talha Farooq, SVO, I/C Vaccine filling
section
Dr. Muhammad Shoaib Noor, SVO, R&D
section / Quality control
Dr. Abeera Mubarak, SVO, Quality
Control section.
 CONT….
Tasks Trainees
3. Efficacy Testing and  Dr. Sajjad Hussain, APVO, R&D/ Quality
Potency Testing control
 Dr. Muhammad Shoaib Noor, SVO, R&D
section / ELISA Lab.
 Dr. Abeera Mubarak, SVO, Quality Control
section.
 Dr. Rehan Rafique, VO, R&D
4. Discussion and  Dr. Sajjad Hussain, APVO / Additional Director
finalization of SOPs  Dr. Agha Asaad Nayyer, SVO I/C O-Type
 Dr. Talha Farooq, SVO, I/C Vaccine filling
section
 Dr. Muhammad Shoaib Noor, SVO, R&D
section / Quality control
 Dr. Abeera Mubarak, SVO, Quality Control
section.
 Dr. Shaukat Ali, SVO, I/C Asia-I
 CONT….
Tasks Trainees
5. Antigen Dr. Sajjad Hussain, APVO, A-type Section
concentration Dr. Farooq Yousaf, VO, Section A-Type
Dr. Agha Asaad Nayyer, SVO I/C O-Type
Dr. Ayesha Rana, VO, Section O-Type
Dr. Shaukat Ali, SVO, I/C Asia-I
Dr. Abdul Wahab, VO, Asia-I Section
6. 146s Testing of Dr. Sajjad Hussain, APVO, R&D/ Quality
the Vaccine control
Dr. Muhammad Shoaib Noor, SVO, R&D
section / ELISA Lab.
Dr. Abeera Mubarak, SVO, Quality
Control section.
Dr. Rehan Rafique, VO, R&D
 CONT….
Tasks Trainees
7. Proper  Dr. Sajjad Hussain, APVO, R&D/
Batch Quality control
Released  Dr. Talha Farooq, SVO, Vaccine
Testing filling Section.
 Dr. Muhammad Shoaib Noor,
SVO, R&D section / ELISA Lab.
 Dr. Abeera Mubarak, SVO, Quality
Control section.
 Dr. Rehan Rafique, VO, R&D