Biologicals Manufacturing Division: Pushing towards growth and innovation

Moving forward towards excellence is never an easy feat, but that is exactly what the Biologicals Manufacturing Division (BMD) is doing. For 30 years, BMD has been working with the Department of Health (DOH) towards responding to the country’s need for vaccines.

On the 30th of January 2017, BMD commemorated its 30th anniversary. The celebration was a humble one but boasting with pride on the numerous accomplishments BMD has had over the years.

The highlight of the celebration was the commendations to outstanding employees over the years and the unveiling of the audio-visual presentation entitled ‘BMD Before, Now and Beyond’ which showcased the growth of BMD from its early days to its transfer in the Research Institute for Tropical Medicine (RITM).

BEFORE: The Biologicals Production Service

In 1805, King Charles IV of Spain sent a scientific expedition – La Real Expedición Filantrópica de la Vacuna (The Royal Philantropic Vaccine Expedition), to Manila. The world’s first immunization campaign was headed by Dr. Francisco Javier de Balmis, court physician of the Spanish crown, the mission carried the Vaccinia virus to the archipelago and maintained it by serial passages in children, who were purposely brought along in passage.

A year after the expedition, a Central Board of Vaccination was created to propagate and produce smallpox vaccine. This was followed by the establishment of the First Municipal Laboratory in Manila. In 1893, the Central Board of Vaccination was reorganized, paving the way for the formation of the Bureau of Governmental Laboratories in 1901. The latter was renamed Bureau of Science in 1905 where the production of smallpox vaccine begun.

In 1920, the Serum and Vaccine Unit of the Bureau of Science was transferred to Alabang, Muntinlupa. It was renamed as Alabang Serum and Vaccine Laboratories (ASVL) and was transferred to the University of the Philippines in 1936. Through Executive Order 94, the Division of Laboratories that includes the ASVL was created and incorporated with DOH.

Three years after, the Division of Laboratories was transformed to Public Health Research Laboratories (PHRL). In 1958, PHRL was replaced with the Bureau of Research and Laboratories (BRL), making ASVL a division of BRL. On the 30th of January 1987, ASVL was separated from BRL and became a support service of DOH known as the Biologicals Production Service (BPS).

The year 1999 marked the transfer of BPS to RITM as well as the start of the Vaccine Self-Sufficiency Project (VSSP). BPS then became the Biologicals Manufacturing Division (BMD) that people know today. In 2001, a new Current Good Manufacturing Practice (cGMP)-certified vaccine production plant was established in RITM.

NOW: The Biologicals Manufacturing Division

With the aim of improving vaccine production and boosting productivity, BMD established the Vaccine and Antisera Study Group (VANTUG) in 2016, a team under the new Vaccine Research and Development Committee (VRDC). At present, RITM-BMD is lead by Dr. Noel G. Macalalad.

The division is currently producing two vaccines: the freeze-dried Bacillus Calmette–Guérin (BCG) vaccine in its experimental stage and the Purified Cobra Anti-Venom (PCAV).

BMD Production Department Chair Ms. Cristina Ruga emphasized, “RITM is the sole manufacturer of PCAV in the Philippines. We have future plans to innovate our PCAV product here at BMD. We plan to shorten the length of time of production process by adopting a new technique that will also increase the number of ampules produce per lot. Hopefully, by second semester of this year, we can start the pre-qualification for the innovation of our anti-venom.”

Recently, BMD is starting to revive the VSSP initiative between RITM and DOH. VSSP aims to produce vaccines for DOH’s Expanded Program on Immunization (EPI), including the revival of BCG vaccine production.

Subsequently, BMD also pursues funding from the Philippine Amusement and Gaming Corporation (PAGCOR) and Health Facilities Enhancement Program (HFEP) to cover the facilities, production costs and equipment.

BMD is also continuing its drive to enhance the knowledge, skills and capabilities of its Quality Control Department staff.

To fulfill the growth and expansion of the biological products being manufactured, the revival and development of Bacterial Typing Antisera, BCG Vaccine, and Equine Rabies Immunoglobin (ERIG) are currently in progress.

Ms. Ruga also talked about the legacy that comes with being part of BMD. She said “Our senior staff here at BMD underwent trainings abroad in their respective fields and specializations. They have years of experience and capability to produce under their belt. Meanwhile, BMD management is currently conducting continuous currently cGMP and Cold-chain Breakdown Trainings to equip the staff the basic and most relevant manufacturing work routines.”

BEYOND: BMD in the years to come

Hundreds of years have passed since the Balmis expedition arrived in the Philippines. On April 15, 2004, a marker was mounted at RITM in honor of the expedition. At present, the Balmis Building also houses the BMD office.

In the coming years to come, BMD plans to create new departments as well as hire additional manpower to aid in the production of vaccines and biologicals. New vaccines are aimed to be produced every year and researches are continuously being conducted to keep up with the latest innovations in vaccine production and to tame the current supply-chain complexity.

BMD has a lot more to offer, whether as a division of RITM or as the leading vaccine producer in the country. Big changes are in store for the year 2017 and beyond.

by Ma. Patricia Lansang