Biosynth, a supplier of critical raw materials and tailored services for the life sciences and diagnostics sectors, has opened a newly expanded GMP bioconjugation suite at its Berlin facility.
The new suite extends Biosynth’s capacity for the GMP production of bioconjugates, supporting projects from early clinical development through to late-stage clinical supply and commercial manufacture.
The expansion enhances the company’s capabilities in conjugate vaccines and drugs, activated polyethylene glycols (PEGs), and polymer-based drug delivery excipients, strengthening its position within its international manufacturing network.
These cleanrooms contain additional laminar flow benches (class A) for sub-aliquotation and sampling
Biosynth told Cleanroom Technology that the expansion was a group project involving multiple contractors with different responsibilities.
This included:
- Wesemann Reinraumtechnik for the construction
- CSA4Lab which was subcontracted for the cleanroom technology and air systems
- Briem for the monitoring systems
- Concept GMP Engineering for the facility planning and GMP consulting
- Projekt R3 were used for the cleanroom qualification, and Cytiva for the production equipment, design, qualification and training
The cleanrooms were of Grade C and D with a production area of 135 sqm and a total facility area of 257 sqm.
These cleanrooms also contain additional laminar flow benches (class A) for sub-aliquotation and sampling.
The facility has air conditioning with temperature and humidity control and is equipped with separate exhaust air vents for gases that may occur during bioconjugation reactions.
In addition, the site is also equipped with tangential flow filtration (TFF) and chromatography systems suitable for batch sizes from 1 to ca. 200 g, or operating volumes between 0.5 and 1000 L.
The site operates on a single use approach, replacing tubing that comes into contact with products to avoid cross-contamination, and keeping each production separate with line-clearance between each one.
Frank Leenders, General Manager for the Berlin site, told Cleanroom Technology: “It has been an expansion a long time in the making, as we always knew that to really meet our customer’s needs, we would need to expand our facility to support commercial phase projects.
The expansion enhances the company’s capabilities in conjugate vaccines and drugs
Thomas Eisele, Chief Operations Officer at Biosynth, said: “This suite enables the scalable, diverse, high-quality conjugation services that our customers need to advance to the next generation of therapies.”
Frank Leenders, General Manager for the Berlin site, added: “The construction of our new facility, including Class D and C cleanrooms, represents a natural evolution of our Berlin operation—in many ways we are growing alongside our customers. The additional refurbishment of our existing facility enhances our GMP manufacturing capabilities, reinforcing our commitment to meeting the evolving needs of our customers.”
Marie Leblanc, Executive VP of Life Sciences, noted the importance of this development for Biosynth’s customers: “Conjugation chemistry, advanced polymers and bioconjugation production are critical areas for many of our life science customers. Being able to support projects fully, from initial bioconjugate process development to commercial GMP supply, enables us to provide specialised conjugation solutions for diagnostics and therapeutics—strengthening our position as a trusted partner in the life science industry.”
