Customer references: Biopharma

A world first in plasma fractionation

Since 1901, Instituto Butantan has been producing immunobiologicals for public health purposes and is responsible for the majority of vaccines and sera produced in Brazil. Butantan has a long tradition of developing processes in close collaboration with local and international universities.

As there was no production of plasma-derived medicinal products in Brazil, the Government of Sao Paulo initiated a project to set up a human plasma fractionation plant together with Butantan. One of the key criteria in selecting technology was the ability to develop production processes for new products easily. Ultimately, they selected the full chromatographic process for the plant.

Neste Engineering Solutions has a long history of developing novel processing steps and methods for the plasma fractionation industry. In addition to the traditional Cohn method, we have been involved in developing other plasma fractionation and purification methods, including fully chromatographic processes.

To achieve these results, Neste Engineering Solutions delivered:

  • User Requirement Specification review
  • Concept Design
  • Basic Design
  • Detailed Design supported with local companies
  • Procurement support
  • Lump-sum turn-key automation delivery

Key customer benefits

  • Reliable and competent design partner bringing continuity to the engineering
  • EMA- and ANVISA-compliant design solutions
  • Full evaluation of URS
  • Modular design allowing easy expansions
  • Planning and obtaining official permissions
  • Opportunity to develop new technologies and solutions with co-development partner

Successful international technology transfers

Founded in 1948, the Finnish Red Cross (FRC) was one of the best-known producers of high-quality plasma-derived medicinal products (PDMP) in Europe. All of the processes were developed in-house in co-operation with other European Red Cross fractionators, and several of these, adopted by the first companies to start the plasma fractionation industry, are still in use today. These include reactors at room temperature, Westfalia centrifugation, filter aid filtrations, continuous thawing, automated CIP, DCS-based automation and nanofiltered IVIG and FIX processes.

With a growing demand for traditional PDMPs and a number of new products, FRC needed to increase capacity from 60,000 litres up to 600,000 litres of plasma per year for some products. The product portfolio was increased being at peak 2004 when IVIG production was transferred to Sanquin in the Netherlands and modified Cohn production processes went to Reliance in India.

To achieve these results, Neste Engineering Solutions delivered:

  • All design and implementation services
  • EPCM continuously since 1978
  • All pre-commissioning, Commissioning and Qualification (IQ, OQ) services
  • Full Documentation management
  • Lump-sum turn-key automation deliveries
  • Start-up and operation support
  • Operator training
  • Technology transfer support

Key customer benefits

  • Reliable and competent design partner bringing continuity to the engineering
  • Compliant design solutions
  • Full evaluation of URS
  • Design allowing easy expansions
  • Planning and obtaining official permissions
  • Opportunity to develop new technologies and solution with co-development partners

Landmark project in China

Founded in 1985, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (Shuyang) produces and sells a wide range of products, including high-quality plasma-derived medicinal products ("PDMP"). It has a production facility in Chengdu, China. The company also has its own R&D team, which is intensively developing both existing products and new ones. Plasma for fractionation is collected and tested in Shuyang's plasmapheresis centers and then transported to cold storage. However, Chinese regulations prohibit recovered plasma being used for fractionation. The collection of source plasma is growing rapidly because an expansion of the fractionation capacity in China is urgently needed. In 2016, Shuyang was one of the dominant manufacturers of Human Albumin and Immunoglobulin, with over 70% PDMP market share in China.

To meet the growing demand for PDMPs, Shuyang started a project to build a world-class, state-of-the-art large-scale multiproduct human plasma fractionation plant. Because Chinese companies have, until now, only fractionated 11 different plasma proteins, all major plasma companies are accelerating their R&D efforts to develop more products. For this purpose, they needed to find a global partner to draw up the concept and basic design of the new plant.

The concept design is the most influential phase of the entire project, as the most suitable process concept must be defined out of several different alternatives. This phase has the biggest impact on the investment cost and overall functionality of the plant. Ultimately, Shuyang was convinced that Neste Engineering Solutions had the specific plasma fractionation expertise and requisite capability to design such a large plant based on brief user requirement specifications (URS), which were still under development.

To achieve these results, Neste Engineering Solutions delivered:

  • URS review and update
  • Alternative solutions as basis for final selection
  • Process scheduling
  • Comprehensive concept design including plasma cold storage, upstream ethanol fractionation, downstream purification, fill and finish, warehouses, all utilities and supporting functions
  • Project planning and cost estimates
  • Full basic design for the production

Key customer benefits

  • EMA and China FDA compliant design solutions
  • Full evaluation of URS
  • Robust concept for a greenfield plasma fractionation plant with all supporting functions
  • Plant cost estimate
  • High quality basic design
  • Owner's team support