Dow Institute of Life Sciences (DILS)

About DILS

Dow Institute of Life Sciences (DILS) Biopharmaceutical manufacturing facility was conceived in 2015 in the Ojha Campus of Dow University Health Sciences. The manufacturing facility of DILS is designed and equipped to manufacture, fill, pack and test biological products and vaccines  products in compliance  with clean room ISPE and WHO Guidelines and equipped with most advanced production machinery for Biological and Vaccine Preparations. DILS got Drug Manufacturing License (DML) in April 2020 by way of formulation for Sera. In Jun 2021 DRAP approved Vaccine section for manufacturing of attenuated/killed vaccine.

Currently DILS has a capacity to fill and pack 10 million packs and Lyophilized one million packs. A total headcount 15 people are working. In future we need 45 people to operate the facility in compliance .Future Strategy of DILS is developed as Pakistan largest Biopharmaceutical Company and manufactured indigenous vaccine

Dow Institute of Life Sciences was established in 2015, with a concept to develop and manufacture Anti-Snake Venom in the province of Sind. In the end 2019 project is revived by hiring skilled and experienced persons from pharmaceutical industry, Quality Management System (QMS) is developed by a hired team. Plant is started according to regulatory requirements and standards. An inspection team from Drug Regulatory Authority (DRAP) of Pakistan visited and audited the plant for manufacturing Licenses for sera vaccine filling. In April 2020 Drug Manufacturing Licenses by the way of formulation for sera filling was issued by DRAP. Dow University of Life Sciences is the first university of Pakistan.

In Jun 2021 second section of Vaccine filling is also approved for killed vaccine filling by DRAP, This will support financial feasibility Currently three commercial batches of Rabies vaccine have been filled and will be marketed after release from NCLB (National Control Laboratory for Biologicals). The facility aims to produce other products e.g. Polio vaccine, Tetanus toxoid and is under negotiation process with third party importers.

Dr. Izhar Hussain

We are committed to fostering excellence in education, research, and innovation in the field of life sciences. Our mission is to nurture the next generation of leaders and professionals who will drive advancements in healthcare, biotechnology, and environmental sciences.

With state-of-the-art facilities, cutting-edge research labs, and a dedicated team of faculty and staff, we provide a dynamic learning environment where students can thrive and excel. Our curriculum is designed to impart both theoretical knowledge and practical skills, equipping our graduates with the tools they need to succeed in today’s competitive world.

Furthermore, our research endeavors aim to address some of the most pressing challenges facing society, from combating diseases to preserving the environment. Through collaboration and interdisciplinary approaches, we seek to make meaningful contributions to the advancement of science and the betterment of humanity.

As we embark on this journey together, I encourage you to seize every opportunity for growth, learning, and discovery. Whether you’re a student, faculty member, researcher, or industry partner, your contributions play a vital role in shaping the future of life sciences.

DILS Biotech Facility

Dow Institute of Life Sciences (DILS is a Biotech facility. The DILS plant is capable of manufacturing and filling biological products. This plant is the first and only biotech facility of the province of Sindh. After NIH Islamabad it is the second fully equipped facility in Pakistan. 

In March 2020 the Drug Regulatory Authority (DRAP) carried out the inspection, GMP compliance audit is found in compliance at Dow Institute of Life Sciences. A Drug Manufacturing License issued by DRAP with sections designed and approved for dedicated manufacturing of Serum based Biological drugs and Vaccines.

 Dow Institute of Life Sciences, a biopharmaceutical facility strictly adheres to GLP (Good Laboratory Practices) and cGMP (current Good Manufacturing Practices) and DRAP Drugs Act 2012

Dow Institute of Life Sciences having assistance from the expertise of the DUHS R&D team, we can develop and introduce unique, disease specific biological drugs and vaccines according to the needs of the consumers keeping in mind patient safety.

Quality is the pillar of all activities, systems and processes that enables an organization to deliver outstanding products to the patients and customers. Dow Institute of Life sciences believes in delivering high quality biological drugs and vaccines by embedding robust quality checks and processes in every step of its technical operations along with its core values hence gaining the trust and confidence of its customers.

To become self-sustainable in biopharmaceuticals through research and development by commercializing economical healthcare solutions with quality standards and services accessible and affordable to all cross sections of the society. In order to achieve the manufacturing Excellence DILS are establishing the following section:

Originally the DILS plant was designed to manufacture Anti-Snake Venom. The idea was conceived in 2012 as approx. 40000 cases of snake bite were reported annually and the situation seems worse than compared to our culture of non-reporting and collection of accurate data are  weak areas of our society.

The availability of Anti Snake Venom is not secured as it is imported from India. Furthermore NIH Islamabad productivity is not sufficient to meet Pakistan market demand. In-addition the efficacy of product need to be improved as it is indigenous product  

Dow Institute of Life Sciences (DILS) established the manufacturing facility for Anti Snake Venom manufacturing. The production area is equipped with Centrifuge, Fractional filtration of plasma equipment( Akta Plus) , Aseptic filtration Assembly  for manufacturing of bulk . For filling and packing of finished products we have a vial washing and depyrogenation tunnel, a filling machine for bulk filling, Lyophilizer for freeze drying and final aluminum sealing machine. Packing and labeling machines are available.

The production area is facilitated with HEPA filters and qualified for Class 100 clean/ sterile areas. The DRAP auditors inspected the facility and it is in compliance with the GMP standards. In March 2020 issued the Manufacturing License.

In current availability anti-Rabies Vaccine is also in acute condition in Pakistan Market. An approx. 400, 000 vail dose is required for Pakistan. The source of supply is not secured as it is imported.

The Dow Institute of Life Sciences (DILS) established the Anti-Rabies Vaccine and Vaccine filling section. The layout of the plant was revised to accommodate the anti rabies section and other vaccine product flow. The layout is already approved by DRAP. In June 2021 the DRAP team visited to audit the facility’s new section and verbally agreed that section is meeting regulatory standards. We are expecting an official License of Vaccine in the coming month. 

There are distinct manufacturing areas for dispensing, centrifuge and purification, sterile filtration & sterile filling and packing operations. These are interconnected clean rooms of varying grades, Filling LFC is Grade A (Class 100), Filling room, Changing  rooms are Grade B (Class 1000) and other areas have air quality complying with Grade C (Class 10,000) environment. Hence, each manufacturing area provides a background environment suitable for the operations performed.        Warehouses (Raw Material, Packaging Material and Finished Goods) are also available on the same ground floor. In addition to that, commercial production is to start in Dec 2023, Three batches are completed and under approval with the regulator.

A cold store 60 cubic meters is installed in the warehouse which can accommodate around 100K vails of finished packs.

In Dow Institute of Life Sciences (DILS) we have state of the art equipment and trained persons. We can carry out quality attribute tests of all types of Vaccine.

We have ELISA and SDS page latest model with software which test protein and viruses as well HPLC , osmolality meter, UV spectrometer , FTIR spectrometer and centrifuge are available as handle any type Vitro testing 

For VIVO testing Animal lab is also present to carry out any testing. We fully dedicated animal house which managed as regulatory requirements.

Facilities

Our Research and Development Laboratory is the heartbeat of innovation, dedicated to the development of safe and effective biological products. Equipped with state-of-the-art technology, our lab features a range of specialized equipment including Centrifuges (8R & 16R), Lyophilizer (Christ), and Biological Safety Cabinet (BSL II). The lab also boasts a Lab scale Lyophilizer (Christ) model Beta1-8LD plus for precise and controlled experimentation.

In our Immunochemical & Wet Chemistry Lab, we focus on the development of cutting-edge solutions. Our skilled team utilizes instruments such as ELISA, Gel Electrophoresis, and Western Blotting to perform immunochemical assays in adherence to Pharmacopoeia Specifications and WHO guidelines.

We excel in analytical test development, ensuring our products meet the highest standards. Our lab employs ELISA and SDS tests for in vitro safety and efficacy testing, guaranteeing the quality and reliability of our biological products.

Our Dedicated Stability Room is the cornerstone of our commitment to product quality. Equipped with a Stability Chamber (Binder – 700 liters) and a Refrigerator (2-8°C of 250 liters), this lab is dedicated to storing biological products for accelerated and long-term stability studies.

ELISA (Enzyme-Linked Immunosorbent Assay): Our ELISA testing services are designed to detect and quantify specific proteins or antibodies in biological samples. This highly sensitive assay is widely acknowledged for its precision and reliability. By leveraging ELISA technology, we can assess the safety and efficacy of various biological products, providing crucial insights into their performance.

The SDS test is a vital component of our in vitro testing arsenal. SDS is a detergent used to denature proteins, enabling the analysis of their molecular weight. This test is particularly valuable in characterizing and ensuring the purity of biological products. Through SDS testing, we meticulously examine the structural integrity of proteins, contributing to the overall safety profile of the tested substances.

Our Microbiology Lab is designed to meet and exceed international standards (USP/EP/WHO). From sterility tests to environmental monitoring of sterile areas, our lab is equipped with advanced instruments and a Biological Safety Cabinet (BSL II).

Our lab features top-of-the-line Oven and Incubators, ensuring optimal conditions for the development and testing of biological products.

The heart of our manufacturing capabilities lies in our Production Section. Utilizing modern and sophisticated European and Chinese equipment for Biological and Vaccine Production, our clean rooms are in strict compliance with ISPE and WHO Guidelines. DILS proudly houses the exclusive Riera Nadeu, an EU certified centrifugation equipment (Capacity: 11.2 liters), used for the purification and fractionation process of biological products.

Our Solution Preparation Area is equipped to ensure the accurate and precise preparation of solutions for the manufacturing process.

Our Aseptic Vial Washing & Filling Line, with a fill volume of 0.5ml-30ml, ensures the highest standards of cleanliness and accuracy in the production of biological products.

Our cutting-edge Lyophilizer Tofflon technology guarantees the preservation of the biological integrity of our products through advanced lyophilization.

With a Cap Sealing Machine (60-120 vials per minute) and a Labeling Machine (60-150 vials per minute), we ensure the efficient and precise packaging of our products.

Our Cold Store, a spacious walk-in facility, guarantees the integrity and longevity of our products by maintaining optimal temperature conditions.

Our commitment to quality extends to our Water Treatment Plant, featuring Reverse Osmosis with EDI Plant and a Water Distillation Plant, ensuring the purity and safety of the water used in our processes.

Contact Us

DOW INSTITUTE OF LIFE SCIENCES (DILS)

Call

Phone:

Ext-

E-mail:

irfan.malik@duhs.edu.pk

Address

Suparco Road, Ojha Campus,

Dow University of Health Sciences, Karachi