Transferrin
Cell Culture products from BBI
BBI’s cell culture media components primarily consist of our range of human transferrin products. Transferrin is a vital component of cell-growth media for a wide range of applications delivering iron to support cell propagation.
Transferrin is manufactured at significant scale; BBI prepares approximately 5kg lots under rigorous batch control. These products have been manufactured by BBI for over 25 years, supplying some of the world’s leading cell culture media manufacturers.
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FAQs
What is the source material for the Transferrin?
BBI derives it’s purified Transferrin products from pooled normal human plasma from predominantly US based paid blood donations.
What are the different forms of Transferrin available?
The standard Transferrin products supplied by BBI are lyophilised products, material is available with different levels of iron saturation. Circulating Transferrin is partially Iron saturated however for cell culture use BBI adjusts the iron content to provide the following options:
- Holo-transferrin (product code T101-5) is adjusted to give near 100% saturation (1200-1700 µg/gm).
- Apo-transferrin (product code T100-5) is depleted to give near zero iron bound (<50µg/gm).
Customised Transferrin formulations are available on request.
What controls are in place for the collection of the blood used as the raw material?
Human plasma used for the manufacture of the BBI product human transferrin is collected at blood centers in the United States of America which are licensed by the United States Food and Drug Administration (FDA).
The material is manufactured from a large pool of plasma donated by multiple donors, although the donor’s information is not made available, all donations are traceable back to the donor.
All plasma donations are screened for infectious diseases by FDA approved methods at the donor level. Donations are ethically sourced and informed consent forms are signed by each donor prior to donation, the forms are kept on file by the approved collection facility.
What regulatory system covers the Transferrin production? Are the transferrin products GMP/ clinical grade products and can it be used for therapeutic products?
BBI prepares Transferrin under it’s ISO13485, 2016 quality system however the transferrin products are prepared in open laboratories and the material is not GMP/clinical grade. Transferrin is intended for research and cell culture use only and is not suitable for use in pharmaceuticals.
How is the material supplied? (What is the product’s appearance?)
Our standard Transferrin products are supplied as lyophilised powder packed in PET bottles in sealed pouches to protect the material from moisture. The product appearance will vary between products depending on the formulation and protein characteristics.
How do I store the supplied material?
Transferrin products should be stored at 2-8°C. After the Transferrin has been removed from the sealed packaging the material should be used immediately, it should not be stored for re-use.
What is Transferrin and how is it used?
Human transferrin is a major constituent of blood plasma. It is an iron binding glycoprotein that serves as the transport protein for iron delivery in the body. Each molecule of transferrin specifically binds two Fe3+ molecules through a bicarbonate mediated site-specific binding.
Transferrin is required by many mammalian cells during growth to regulate iron uptake and it has been shown that when added to cell culture media it promotes cell proliferation. In culture media, transferrin has a secondary role to bind endogenous metal ions which may cause cell toxicity.
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Transferrin production
BBI produces our Transferrin products at our site in the UK under the umbrella of our ISO13485;2016 regulated quality system. The carefully controlled plasma raw material comes from licenced plasma collection centres based in the US. The Transferrin products are purified and formulated using a WHO recognised viral inactivation heat treatment step and terminal 0.2µm filtration, to give assurance of the product safety prior to lyophilisation.
Quality control checks ensure the material is low in endotoxin and is characterised by a range of analytical tests to ensure product quality. The material is supplied for In Vitro and further manufacturing use.
Cell Culture production
Techniques involving the propagation of In Vitro cell lines have become very important in recent years. Growing cells outside the body has previously relied on animal derived serum products such as Fetal bovine serum which can potentially pose a risk of contamination of the cell line.
Using serum free media, where essential components are required to support successful cell growth, is now relied upon, with components sourced from defined, reliable safety assessed source materials and manufactured in a highly regulated environment. One of the key components of a successful serum free medium is human Transferrin, the protein that acts as a transporter to deliver iron to the cell during its growth phase. BBI provides human Transferrin as a critical component for cell culture media.
The human plasma raw material is sourced through a highly regulated supply chain, ensuring the safety of the plasma through the use of material from FDA regulated plasma collection sites in the US.
Screening and purification
Collected plasma is carefully screened at the donor level by the latest sensitive methodologies to test for and screen out human transmissible viruses. The collected plasma is fractionated and then the Transferrin is purified through a well-established and controlled methodology under the controls required by an ISO13485;2016 registered manufacturing site. Both Iron saturated (Holo) and Iron poor (Apo) Transferrin preparations are manufactured in significant volumes.
The Transferrin undergoes a pasteurisation step for additional safety reassurance prior to being 0.2µm filtered, lyophilised and packaged into bottles with secondary packaging designed to prevent moisture ingress. A wide range of analytical techniques are then used to assess the quality of the Transferrin. These techniques are designed to assess a range of physical characteristics of the Transferrin protein and assure the lot-to-lot reproducibility.
Other tests such as endotoxin testing, bioburden testing and mycoplasma screening ensure that factors which could be harmful to the propagation of a cell line have been excluded. The performance of Transferrin in supporting and accelerating cell growth has been proven with a range of different cell lines.
Core Competencies
Our product range includes enzymes for biosensor, immunoassay, clinical chemistry, molecular and pharmaceutical applications with a range of different grades to suit all applications.
We aim to develop, manufacture and supply high quality enzymes which meet both customer and regulatory requirements.
We use quality raw materials, innovative production methods and product formulations to achieve maximum stability for our products. We test our products regularly to ensure this remains consistent.
If one of our off-the-shelf products does not meet your requirements, we can offer custom development and manufacturing services to deliver an enzyme to your specification, perfect for your application.
BBI's Capabilities
Specialists
We have extensive experience in sourcing raw materials worldwide
Salt/solvent fractionation
Batch sizes of up to 5,000 litres
Chromatography
Ion exchange chromatography, affinity chromatography, size exclusion chromatography, hydrophobic interaction chromatography
Crystallisation
Highly effective protein purification using solvent and aqueous media
Ultrafiltration
Volumes of 2,500 - 30,000 litres
Freeze drying
Capability of 49 - 420 litres per cycle
Quality control
In-process analysis and monitoring, development of assay/test procedures
Product handling/sampling
We offer special packing according to customer specifications