Articles
Share
As a trusted serum supplier, it is important for Captivate Bio to connect and stay up to date with how the International Serum Industry Association (ISIA) supports the global animal serum industry. We recognize that to remain competitive and ensure that we are meeting not only industry standards but also our customers’ expectations, we must stay ahead of the game with continuous learning. Our goal is to make sure we are able to apply the latest ISIA guidance to support our research customers globally.
The ISIA recently hosted its first meeting since the pandemic in Athens, Greece. Members of Captivate Bio’s management team attended this two-day event where we took the opportunity to learn about the historical challenges faced in the serum industry, including learning about serum traceability and regulatory updates. As a first-time attendee, Lori Oakes, Managing Partner at Captivate Bio provides a great summary of this year’s conference and how the latest changes impact research programs, all while enjoying the sights, sounds, and the amazing food of Athens.
During the first day of the conference, we learned that while scientists have been supplementing cell culture media with Fetal Bovine Serum since 1950, it would take another 56 years for an official trade organization for the serum industry to be established. It wasn’t until 2006, when a group of commercial serum suppliers collaborated to form the ISIA to define common, industry accepted standards, and quality control practices, for traceability and standardization of serum for research in order to combat counterfeit products. Up until this time, serum suppliers and scientists were left to navigate the raw material and regulatory guidelines independently, leading to supply challenges, pricing irregularities, and quality issues in the marketplace.
We also learned that because ISIA membership has grown significantly over the years, the ISIA has established committees to address serum traceability, regulatory, standardization, and marketing challenges globally. This year’s annual meeting provided a platform for each of these committees to present updates while offering attendees of the meeting time for networking and views of The Acropolis, an ancient citadel, from the hotel rooftop dining room.
We learned on day two of the meeting how each committee supports the animal sera industry. To kick things off, the Traceability Committee showcased their guidelines for audits, publications, and certification in order to ensure that the animal serum source and origin are reported truthfully and with integrity. Ultimately, suppliers should be able to support finished serum with documentation and proper labelling that reflects a true and accurate description of the product. The ISIA now offers a traceability certification program to serum suppliers, using independent, third-party, ISIA approved auditors. Any serum supplier who undergoes the ISIA audit and is found to be compliant, can use the ISIA seal on marketing materials showing compliance of the ISIA audit program.
Next, the Regulatory Committee focused on the review and upkeep of current and new guidelines issued by the global regulatory agencies, such as the USDA, European Commission, and their counterparts in the UK, Australia, New Zealand, and Brazil, for the import and export of serum, product usage, and quality control. The ISIA committee also works with the international agencies responsible for animal health awareness, such as the FDA, World Health Organization, and the World Organization for Animal Health. Collectively, they continue to educate the ISIA community with any new testing requirements that ingredients of animal origin must meet, and any proposed changes that may impact the serum industry. One discussion underway involves the USDA’s Draft Veterinary Services Memorandum 590 that would change guidance of Title 9 of the Code of Federal Regulations Sec 113.53, and potentially reduce the availability of fetal bovine serum for the veterinary biologics industry.
The Standardization Committee drives technical standards, testing methods, and import/export documents across all geographic regions for the increased transparency and safety for the industry. The group’s activities directly affect the information reported on serum certificates of analysis. The committee presented a recent study performed by the ISIA, where samples of FBS from varying regions including the USA, Mexico, Brazil, Australia, and New Zealand, and compared the pH, osmolality, and total protein. Their findings showed that there were no significant differences due to geographic origin.
The ISIA wrapped up the meeting with the launch of their newly updated website which will provide tools to support ISIA members with ongoing updates, educational modules, and serve as a serum information resource. Members now have access to direct links to country specific regulatory agencies, import/export regulations, government legislation, ISIA position papers, and more.
Not only did we network and learn a ton about the ISIA and the importance of standardization in animal serum, traveling to Greece allowed us to see the beautiful sites of Athens for the first time. We began our journey by visiting the ancient ruins of the Acropolis, a very tall hill, with amazing views of the city, and home to the Parthenon, a religious temple built for the goddess of Athena and the Theatre of Herodes Atticus, which seats 5000 individuals and is still used today for various performances.
Before heading to the next site, we rewarded ourselves with a late lunch of traditional feta cheese, Greek olives, and grilled pita, followed by freshly fried zucchini. Once refreshed we ventured off to the Roman Agora, Arch and Library of Hadrian, and the ancient cemetery of Kerameikos. Later in the evening we took a quick taxi to Flisvos Marina, a local shopping and luxury-yacht site for dinner and the beautiful sunset.
We closed our trip by touring the Temple of Poseidon at sunset, and left Greece fulfilled with serum industry facts and these amazing views:
Trusted by both academic and industry customers, Captivate Bio has become the go-to supplier for premium and specialty serum solutions with fast service and consistent supply. Our team works directly with key manufacturers in securing reliable supply. Contact our team today to request a free quote on our premium FBS, specialty FBS, animal sera, or human platelet lysate (an FBS alternative).
Image source: H. Guinn, Photographer, Erie, MI
Learn more about how we support researchers with cell culture products, contract manufacturing and storage services, custom reagent sourcing, as well as marketing, sales, and distribution programs for our industry partners.
Thank you for meeting Captivate Bio at ISSCR 2023 - The International Society for Stem Cell Research Annual Meeting that was held in Boston, MA from June 14-17, 2023.
April 2023 - Captivate Bio attends the 18th Annual Meeting of The International Serum Industry Association (ISIA) being held in Athens, Greece from April 26-27, 2023.
Just announced! Join Captivate Bio at Cell Bio 2025 – American Society for Cell Biology Annual Meeting in Philly from Dec. 6-10, 2025.
