The new cleanroom suite boosts GMP capabilities to support conjugated APIs, vaccines, and polymer-based excipients from early clinical phases through commercial supply

Biosynth has expanded its Berlin manufacturing site with the addition of a new GMP bioconjugation suite, strengthening its capacity to serve pharmaceutical and diagnostic clients seeking scalable conjugation chemistry for vaccines, drug delivery, and advanced biologics.

The facility – equipped with Class C and D cleanrooms – enables the production of bioconjugated active pharmaceutical ingredients (APIs), intermediates, and polymeric excipients across the development lifecycle, from early clinical phases to late-stage and commercial manufacturing.

Conjugation chemistry is a critical enabling technology for a growing number of advanced therapies, including antibody-drug conjugates (ADCs), conjugated vaccines, and polymer-based drug delivery systems. The Berlin expansion comes as demand increases for end-to-end partners that can support complex manufacturing processes under GMP conditions.

“We are thrilled to officially open the new expansion to our bioconjugation facility in Berlin, which represents a significant enhancement to our existing operations,” said Thomas Eisele, chief operations manager, at Biosynth. “This suite enables the scalable, diverse, high-quality conjugation services that our customers need to advance to the next generation of therapies.”

The expansion includes newly constructed cleanrooms and a refurbishment of the existing facility, allowing for flexible bioconjugate production within Biosynth’s broader life science manufacturing network.

“The construction of our new facility represents a natural evolution of our Berlin operation—in many ways we are growing alongside our customers,” said Frank Leenders, general manager of the Berlin site. “The additional GMP capacity enables us to better meet the evolving needs of projects in conjugated drug development and diagnostics.”

The site will support projects involving conjugated peptides and proteins, activated PEGs, and other advanced polymers. According to Biosynth, this capability complements the company’s broader focus on critical raw materials, excipients, and contract services tailored to drug development and diagnostics.

“Conjugation chemistry, advanced polymers and bioconjugation production are critical areas for many of our life science customers,” added Marie Leblanc, executive vice president, Life Sciences. “Being able to support projects fully – from initial process development to commercial GMP supply – enables us to provide specialized solutions for diagnostics and therapeutics.”

Biosynth’s Berlin site joins a growing global trend of investment in complex manufacturing infrastructure to meet demand for high-value biologics and targeted therapies. The global market for antibody-drug conjugates alone is projected to exceed $20 billion by 2030, driving increased interest in scalable conjugation services that can ensure quality, compliance, and consistent supply.