Plasma fractionation -
raw materials

for you

SUPPORTING SECURE PLASMA FRACTIONATION

Essential raw materials and excipients for plasma-derived medicinal products (PDMPs)
Plasma treatment

STREAMLINE YOUR SUPPLY CHAIN BY OUTSOURCING ACTIVITIES

In the plasma manufacturing chain, various cleaning and process solutions, buffers, chromatography chemicals, virus inactivation and polishing solutions are necessary for the up- and downstream process. Manufacturers and suppliers of these materials have to secure strict and reproduceable quality standards.

If your organisation chooses to focus exclusively on the core plasma production process, we would be pleased to offer you our GMP-compliant manufacturing services for process chemicals, buffers and excipients. Outsourcing these process steps optimises your supply chain, increases your internal productivity, and contributes to long-term cost reduction. Furthermore, it reduces the risk of supply chain disruptions by establishing a logistics concept with defined safety stocks, 365/24/7 availability, and close collaboration with our supply chain.
A "make or buy" decision involves determining whether to create a product or service in-house or purchase it from an ex-ternal source. In the context of customised GMP (Good Manufacturing Practice) biopharmaceutical process solutions, this decision carries several advantages.

PLASMA MANUFACTURING – A HIGHLY COMPLEX AND DEMANDING PROCESS

 

The production of human plasma is a complex and regulated biopharmaceutical process that involves strict adherence to safety and quality standards. The result is a range of life-saving medical products that contribute to improving the health and well-being of countless individuals worldwide.

 

Grafik: Plasma

Plasma and its components

Key characteristics
  • Sensitive to handling and production processes
  • Expensive to source
  • Limited in supply compared to high market demand
  • Require the highest standards of quality and safety

Ensuring an outstanding production process is essential to guarantee plasma protein-based medicinal products of the highest value. Process chemicals and excipients play a critical role throughout the entire plasma value chain.

CG Pharma & Biotech – Your Partner

for plasma fractionation and PDMP production:

  • Extensive experience in supporting the plasma industry
  • EU-GMP certified manufacturing facility with Class C/D cleanrooms

 

  • Tailored solutions for plasma fractionators – customised formulations and a comprehensive standard product catalogue

Our products

 

Our extensive range of high-quality raw materials, starting materials and excipients is designed to meet the unique needs of virus inactivation, precipitation elution and buffer solution preparation, all essential stages in the production of life-saving plasma-derived therapies.

Thanks to our modular approach, you have the flexibility to select and combine the solutions that perfectly fit your needs.

EXAMPLES OF CUSTOMISED BUFFER SOLUTIONS AND THEIR FUNCTIONS DURING PLASMA PROCESSING

PRODUCT

APPLICATIONS

Acetate buffer

Used in precipitation steps, especially for albumin fractionation, to maintain a stable pH

Phosphate buffer

Used in washing and resuspension steps to stabilise proteins and maintain physiological pH.3

Glycine buffer

Used in albumin purification and stabilisation, especially during pasteurisation steps

Tris buffer (tris(hydroxymethyl)aminomethane)

Used in chromatography steps for immunoglobulin purification due to its effective pH buffering capacity

Sodium chloride solution (saline)

Used for dilution, washing and resuspension of plasma fractions

Histidine buffer

Used in final formulation of immunoglobulin products to stabilise the protein

Citrate-phosphate-dextrose (CPD) solution

Used as an anticoagulant and preservative during plasma collection

Ethanol buffers

For rinsing of hydroxyapatite-exchange column

Various buffers

For equilibration, washing, regeneration and purification of proteins