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LABORATORY EDUCATIONAL VISIT

1 Introduction & aims of visit

Educational visit has its own importance in a career of a student by providing an excellent
opportunity for interaction with laboratory industries. Exposure to laboratory industrial
environment will benefit students by exhibiting the potential and functional opportunity of
various different sectors of this field. The Faculty of Health Sciences (FSK), UKM provided a
valuable prospect for its Masters in Health Science (Biomedical Science)1st Semester students
by organizing a visit to Inno Biologics Sdn. Bhd. on 13th December 2018. In addition of
imparting knowledge of industrial environment to students, this education visits at Inno
Biologics Sdn. Bhd. aim to go beyond academics enable students to upgrade their skills using
new concepts obtained during the tours, talks and sharing sessions with the company personnel.
As the main objective of the laboratory industrial visit is to provide students an insight on the
practical applications of what was learned in theory and recent advances in biopharmaceutical
manufacturing, thus supplementing theoretical knowledge for a successful professional career.
This visit is attended by 11 students and 3 laboratory staff headed by Cik Mazlin from FSK,
UKM. Pn Halijah Taib, Head of Quality Management & Regulatory Affairs and two other staff
from Inno Biologics Sdn. Bhd., welcomed the faculties and students and facilitated the talks
and tours. The tentative of the program for the day were as follows:

Table 1:
Time Venue & Activity
10:10 Presentation content:
am - Company background
- Cleaning and upkeep of
laboratory
- Waste disposal
- Handling of raw material
- Warehouse or storage of
material operatio
10:45am Lab Tour:
1) QC Laboratory
2) Raw material storage room
11:45am Light refreshment
Group photo session (Lobby Area)
12:00pm Activities Ended
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2 Company background
Inno Biologics Sdn. Bhd. a Ministry of Finance (“MOF”) Incorporated Company, established
as part of National Biotech Policy (“NBP”) by the Government in 2002. An agency under
Ministry of Energy, Science, Technology, Environment & Climate Change (“MESTECC”), it
established a cGMP manufacturing facility with 200L and 1,000L capacity for the production
of biosimilar products. This Malaysian company aspires to become a world class
biopharmaceutical API contract manufacturer. The objective of the company is to drive the
biotechnology business in the field of production and commercialization of
biologics/biosimilar product for national interest. Its mission: We aspire to be a world leading
business organisation providing biopharmaceutical development and services for better quality
of life; Vision: The leader in innovative biologics development and manufacturing.

Figure 1: Inno Biologics Ventures Sdn Bhd located in Nilai, Negeri Sembilan
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3 Services
3.1 Intro
Mammalian cells are currently the primary system for the production of recombinant proteins
for clinical applications due to their capability for proper protein folding, assembly and post-
translational modification. These mechanisms ensure the quality and efficacy of protein of
interest being produced compared to bacterial systems. Inno Biologics Sdn. Bhd. specialises in
mammalian cell culture technology and operates the state-of-the-art cGMP facility for the
production of biopharmaceuticals. The facility is built to comply with European Medical
Agency (EMEA) and United States Food and Drug Administration (FDA) regulatory
requirements. The company offers complete services from upstream to downstream operation
for the development of therapeutic proteins. The reliable, rapid and cost effective services
reduces risks, cost and time investment ensuring that customers will get the product candidates
into the market in line with their vision and strategy.

3.2 Services
as a result of improvements in media formulation, clonal selection and cell line development.,
productivity in the range of more than 1 gram per liter has been achieved in mammalian cells
cultivated in bioreactors. Cell line development services offered by the Protein Science team
at Inno Biologics includes molecular biology, cell culture, protein expression and verification
as outlined below:
 CLONING AND VERIFICATION OF GENE EXPRESSION
Isolation of gene of interest from biological sources. Cloning of cDNA encoding protein of
interest. Purification of plasmids/vectors. Gene expression analysis.
 PROTEIN EXPRESSION
Transfection of expression vectors into mammalian cells. Screening of transfected cells.
Verification of protein expression and identity. Expansion of selected clones.
 ESTABLISHMENT OF CELL LINES
Selection of high-producing clones using Clone Pix TM FL system. Determination of
expression level of selected clones. Establishment of R&D working and master cell banks.
 ANALYTICAL SERVICES
Various bioassays and analytical tools – PCR, ELISA, SDS-PAGE, etc.
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3 Cleaning and upkeep of laboratory

3.1 GLP & GMP
Before entering the labs, students were briefed on the importance of Good Laboratory Practice
(GLP), GMP, description of optimal working/laboratory area housekeeping, SOP, material
handling and waste management practices of the company. As briefed, GLP are set of
principles intended to assure quality and integrity of non-clinical laboratory studies to support
research or marketing permits for products regulated by government agencies while Good
Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced
and controlled according to quality standards. The GMP practices adhered by the company
among others are as following figure 2.

Figure 2: Flow chart example of GMP practices.

The work area must be free of unnecessary chemicals and kept clean at all times. All accessory
and cable equipment of computers must be kept tidy as well. A logbook to keep tract of items
utilized etc were present in all of the labs we visited. A sample is seen figure 3.

Figure 3: Housekeeping logbook sample.

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3.2 Waste disposal

Wastes produced by the company (Inno Biologics Sdn. Bhd.) can be classified into three main
types: Hazardous waste, non-hazardous waste and Bio-hazardous waste. Bio-hazardous waste
is waste in contact with infectious contaminated materials and should be decontaminated using
autoclave prior to disposal. Examples of bio-hazardous waste include infectious materials,
contaminated agar plates, live cultures and disposables (pipette tips, petri dish, broken
glassware) that have been in contact with infectious materials. Once bio-hazardous wastes are
decontaminated, they will be disposed as hazardous waste. Hazardous waste is scheduled waste
whereby its disposal is performed by hired waste management company such as Kualiti Alam.
Non-hazardous waste (non-schedule waste), waste that are not in contact with chemicals or
biological contaminants are disposed with regular garbage. The management of waste are
detailed in Figure 5.

Figure 4: Waste disposal bags for hazardous and bio-hazard materials.

Figure 5: Flow of scheduled waste

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3.3 Handling of raw material

Material can be defined as items directly or indirectly related to intended use in the process and
to the potential risk that may adversely impact the product’s identity, purity, potency, toxicity
or efficacy. Handling of incoming material using GMP practices is to ensure safekeeping of all
incoming materials and prevent degradation, contamination and/or cross contamination.
Incoming materials include raw materials, packaging materials, cleaning materials and
consumables.

3.4 Warehouse & storage of operation material

The students were briefed about the protocol of receiving operation material or test samples in
the warehouse. Students and UKM personnel were also given the opportunity to visit said QC
Laboratory and raw material storage room, however we were not allowed to take any pictures
and must adhere to the rules outlined to enter the lab. Those entering the labs were required to
wear lab coats, shoe covers, caps and face masks before entering. In addition, both hands have
to be treated with hand sanitizer before entering the QC lab. In the lab, all equipment was clean,
in their designated areas, with identification number, data logging and tracking present. As
informed, the staff in charge of the equipment must be trained to use the equipment and we
were briefed by said staff on the inner workings of a few equipment present in the QC lab. In
the quarantine and storage room, all reagents were labelled and stored appropriately. Items
received will first be stored and processed for approval in the quarantine room. Rejected or
approved materials will then be colour coded using labelled sticker and stored at their
designated areas in the storage room accordingly (Figure 5). Labels on reagent bottle besides
being colour coded, contains name of reagent, manufacturer, date prepared & opened, expiry
date, storage conditions and hazard labels. Quarantine items are colour coded yellow, approved
items green, while rejected items were labelled with red sticker.
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Figure 5: Segregation and storage area floor plan layout.

4 Conclusion
With an aim to go beyond academics, industrial visit provides student a practical perspective
on the world of work and the opportunity to learn practically through interaction and working
methods. These direct benefits of visiting the lab were accompanied by other benefits, such as
the potential networking and future collaborations with personnel carrying out research in Inno
Biologics Sdn. Bhd. In addition to the informative talks, sharing session and laboratory tours,
as the company do offer in house training Program/Workshops it would be beneficial for
inclusion of a more hands on approach for future visits to Inno Biologics Sdn. Bhd. One of the
courses that students or staff can benefit off is The ‘Cell banking cryopreservation procedure
training with demo’ or the ‘Virus purification technology’ training. These trainings are eligible
for HRDF claims under the Skim Bantuan Latihan (SBL) Scheme, subject to prior application
to HRDF by the employers/companies. In conclusion, this initiative by The Faculty of Health
Sciences (FSK), UKM have without a doubt benefited, peaked our interest and enriched us
primarily on the potential and advancements of biopharmaceutical manufacturing especially
on biosimilar product, in Malaysia. The knowledge obtained throughout this visit can be
applied in our chosen field of work in the future.