The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
PT Kalbio Global Medika is one of three 2017 Facility of the Year® Honorable Mention winners for their Biotechnology Facility in Jakarta, Indonesia.Projects selected for recognition with an Honorable Mention Award are typically projects that utilize new technology or are located in a challenging region of the world. These projects do not win for a specific category but are clearly successful projects that overcame significant challenges in planning, execution, and delivery, and deserve recognition for their achievements.
PT Kalbio Global Medika, located in Indonesia, manufactures biological and biotech products for the Indonesian and SE Asia markets. The company vision and long-term goals is to expand outside their region. The 40,000-sq. ft. site, built on a plot in the Cikarang industrial park on the East side of Jakarta was formed in part due to a call from the Indonesian government to encourage in-country biologics and biomanufacturing manufacturing. PT Kalbio Global Medika had a young, ambitious and dedicated team, with an average age of only 24. This team, maintained their expenses to 96% of the initial budget after having completed construction, equipment fit out, and validation with 4% to spare.
Having a forward-thinking team eager to take work as a team to achieve great things aided them in not only meeting but exceeding their goals. A point of pride is PT Kalbio Global Medika’s implementation of a full Quality Management System that is compliant to the PIC/S guidelines and is one of the first in SE Asia that meets the “Risk Based Approach” to manufacturing. PT Kalbio Global Medika also adopted a “green” mentality in their design and operation in an effort to reduce their environmental impact. They used novel methods for decontamination and sanitation as well as solar power to be more energy efficient. ISPE congratulates the PT Kalbio Global Medika team for their achievements and their FOYA award-winning entry. Learn more about the 2017 FOYA Honorable Mention winner.Kalbio_Sterility_Isolator_1.jpg
Has your company recently designed, built, or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class? Submit an entry into the 2018 ISPE Facility of the Year Awards (FOYA) Program, and your facility may win a coveted Facility of the Year Award.
Facility of the Year Awards Banquet - Join ISPE and prominent industry leaders as we recognize the 2017 Facility of the Year Awards (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction, and operation, at the FOYA Banquet on the evening of Tuesday, 6 June 2017 in Arlington, Virginia, USA, during the ISPE/FDA/PQRI Quality Manufacturing Conference.
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...