Single-use technology for fast capacity expansion

Challenged with the task of building a new facility for the production of six monoclonal antibodies (mAbs) with an annual capacity of up to 400 kg, Libbs Farmacêutica sought NNE’s experience in flexible design and Bio on demand™ facilities.

At the start of the project in 2013, the Libbs facility in Embu das Artes outside of Sao Paulo, Brazil was planned as the largest monoclonal antibodies (mAbs) single-use facility in the world. Knowing the market need could grow dramatically, Libbs, NNE and Nordika Brazil worked together to develop a flexible design that could expand quickly to allow for market changes.

Unhindered production

It was critical for Libbs that production felt no impact of the expansions, which drove the decision to increase capacity through a linear scale-up of the bioreactor capacity by one-third of the final capacity (400 kg mAbs) in three phases.

The scale-up strategy ensured a short changeover time for line clearance between different products, the ability to swap equipment to accommodate for the six different mAbs and finally, a phased investment to ensure capital expenditure was not committed until needed.

“NNE’s expertise with the design of single-use facilities for biologics allowed Libbs to quickly reach our goals with smart solutions focused on regulatory approval and easy expansion of capacity without disruption of regular production.”

Carlos Reis, Operations Director at Libbs.

NNE’s expertise with the design of single-use facilities for biologics allowed Libbs to quickly reach our goals with smart solutions focused on regulatory approval and easy expansion of capacity without disruption of regular production,” says Carlos Reis, Operations Director at Libbs.

Designing flexibly and realistically

The new mAbs production area was constructed as part of Libbs’ existing site in Sao Paulo. The facility layout was based on a four-story building concept, totalling 7,000 square metres and boasting the shortest possible distances between daily operations in the compact building.

NNE Global Technology Partner Niels Guldager explains:

Libbs and NNE and Nordika Brazil used our flexible facility design approach known as Bio on demand™. In the design, the production area interfaces are flexibly located on two building levels allowing for expansion of upstream and downstream lines and allowing Libbs to focus on flexibility and organisation on each level.

The process design was developed in a series of design workshops in Brazil and in cooperation between Libbs, PharmScience, NNE and Nordika Brazil.

In November 2016, Libbs received approval from Brazil’s health authorities ANVISA and the first batches GMP batches went online in 2017.

Quick facts

Customer

Libbs Farmacêutica Ltda.

Country

Brazil

Project duration

2013 – 2016

Total investment cost

USD 100 million

 

Services provided

Conceptual design and a basic design including certain detailed design elements to ensure the timeline of the project and allow Libbs to begin construction without delay. In cooperation with Nordika Brazil and PharmaScience, all design was executed with NNE’s Bio on demand™ concept to enable the customer to respond quickly to changing market needs.