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What is recombinant protein?

Recombinant proteins are proteins expressed in bacteria or cells that are inserted by a DNA fragment through the transformation process. To date, about 200 recombinant proteins are produced and used in the rapidly grown protein industry.

Categories of the recombinant protein

There are many ways of classifying recombinant proteins, such as by applications (medicinal and research), by species (animal, plant, bacterial, and viral), and by functions (Chemokines, Interferons, Colony-stimulating factors, Growth factors, enzymes, the proteins for purification (protein A/G/AG/L) and specific interaction or amplification (Streptavidin), etc.).

recombinant protein

How do you choose the proper recombinant protein supplier?

In short, there are two aspects for evaluating the supplier by company and product.  

Company aspect:

Before global pharma or biotech company begins the procurement process, they look for suppliers with previous development history, good financial credit records, company-wide certifications, company scale, quality system, team’s technique and experiences, etc. This becomes the prerequisite and assurance of long-term collaboration.

Product aspect:

  1. Specifications:

The competitive edge of the product is established on the specification. It represents the overall synergistic result from the teamwork of R&D, manufacturing, QC, and warehouse teams.

  1. Batch production scale and lead time:

A company should develop advanced domain knowledge to express proteins in a high cell density with high activity to drive down the product cost. To be able to take large quantities or customized orders in a short lead time, safety stock needs to be stored with enough manpower for any additional urgent needs.
With the right clone that expresses inclusion body form, one can achieve production scale in grams via a pilot-scale fermentation tank. However, there are only a few manufacturers with an annual capacity in tons level. More importantly, it becomes more and more difficult to maintain its unit bioactivity. A qualified recombinant protein manufacturer will have distinct advantages in terms of cost, quality, and lead time.

fermentation tank

  1. Lot-to-lot stability

Specific activity definitely varies between lots due to various factors including age of cells and its passage number, cell density or medium differences each time, and the end user's technique. Therefore manufacturers typically define a range for product specifications and make sure each lot conforms to the specifications. A qualified, well-trained QC personnel needs to examine its appearances, solubility, purity, and biological parameters against its stringent standards. From the initial research stage, pilot production to the full-scale production phase, it is necessary to refine the manufacturing process after each batch to have a secured and stable control in the following production.  

  1. Shelf life

Although specification can demonstrate its strength and values, the formulation has a major impact on shelf life. Longer shelf life means better quality and warehouse management. Typical recombinants can be stored for up to 3 years at -20°C. With small packaging available for one-time use, one does not need to worry about the waste of proteins. Small packaging also minimizes the chances of the freeze and thaw cycle to make sure the quality is consistent across different experiments. 

A proper recombinant protein supplier should have competitive edges based on its production capacity, lot-to-lot stability, and ability to offer different packages for each customer. As the recombination and fermentation techniques can be practiced in almost all biological labs, the capability and experiences of on-site industrial management of production and manufacturing are the core strength a qualified manufacturer should maintain.

 

About Algapharma
Algapharma Biotech Corp holds the core technology in bulk protein production, purification, and protein conjugation. Collaborated with world-leading expertise in large-scale microalgae cultivation by Far East Microalgae Ind. Co. Ltd (FEMICO), Algapharma is the world-leading supplier of phycobiliprotein and its conjugate.


Melody Tsai, VP of Flogen 
Nick Cheh, Director of Business Development, Algapharma, flogensales@febico.com.tw
 

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