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Cell Culture

FAQs

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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.

BBI derives it’s purified Transferrin products from pooled normal human plasma from predominantly
US based paid blood donations.

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.

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. Further details on the collection process are available on specific information sheets or can be requested from technicalsupport@bbisolutions.com.

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.

The specific methodologies are proprietary to BBI however a general purification methodology can be provided after execution of a Non-disclosure agreement.

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, please consult the example Certificate of Analysis (found in the ‘Technical Documents’ section of the product page) for this information.

All our transferrin products will be sent from our Sittingbourne facility directly. Our terms are “FCA” meaning it is the customers responsibility to ensure the package is delivered safely. We use an air courier service and we will make a charge for this service or pass the shipping charges forward.

Transferrin products are shipped on cool-pack packaged in Styrofoam containers with secondary cardboard outers.

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.

A shelf-life of a minimum of 5 years from manufacture date is applied. The shelf life is based on immunological potency.

If any further technical information is required, this can be requested by emailing technicalsupport@bbisolutions.com

Our products are fully tested for Quality and prepared in ISO:13485 controlled laboratories however in the unlikely event of having an issue with the product performance we will endeavour to find a satisfactory resolution. In the first instance contact your account manager who will advise on the course of action to resolve any issue.

These should be sent to technicalsupport@bbisolutions.com for completion. Due to the high number of requests received, BBI has compiled a document of frequently requested information of this nature,
which is available upon request.

BBI do not publish list prices as often product pricing is dependent on volumes and recovery testing. Please contact your local account manager for a product price quotation. If you have not yet have an account manager please contact customerservices@bbisolutions.com.

BBI carries stock of most of the listed products however some specific products are made to order please contact your account manager for specific up to date stock information. If a product is not
available from stock, then the preparation will need to be scheduled. It is essential to ensure forecasts are communicated to BBI in good time (at least 6 months’ notice) to ensure material is available. Stock
can be reserved for a maximum of 3 months pending testing of samples.

These requests can be sent directly to your designated account manager who will be happy to advise of current stock availability and advise on appropriate samples. For products ordered from stock or
against an approved sample orders can be sent directly to customerservices@bbisolutions.com who will direct your request appropriately.

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. 

Technical Documents

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