Recipharm’s modular sterile filling system goes operational with first production run
Contract development and manufacturing organization Recipharm announced that its new modular sterile filling system is now fully operational, and has successfully completed its first production run for a “leading” biotech company.
Recipharm’s system, installed in Wasserburg, Germany, performs aseptic filling within a Grade A isolator and operates in full compliance with GMP standards. The company claims that, unlike traditional large-scale production systems, its unit is optimized for small-batch production providing a fast and flexible solution for clinical development projects.
“The line can deliver 500 to 50,000 units per batch, covering all the development phases of a product,” according to Recipharm. “In addition, the system provides great efficiencies and cost saving, by limiting the loss of high value products to less than 500mL and preserving material for clinical trials.”
Recipharm said the system is complementary to its existing development and commercial filling infrastructure and is an “excellent companion” to the services provided by the company’s ReciBioPharm biologics division.
The system supports different product types, including syringes and vials. Recipharm said it is adding a pre-filled syringe (PFS) module to the installation to expand the system’s capabilities to serve both biotech and pharmaceutical customers.
“With this unit, we offer our clients a flexible, high-quality and GMP-compliant solution for their development and clinical production needs,” Gregor Kawaletz, Recipharm’s chief commercial officer, said in a statement. “This installation reflects our commitment to investing in innovative technologies that enable faster and more efficient pharmaceutical development.”
Building a global network
CEO Greg Behar told Pharma Manufacturing last month that Recipharm, founded in 1995 and headquartered in Stockholm, Sweden, is “one of the oldest CDMOs out there” with a global footprint and more than 5,000 employees worldwide.
Behar, who took the helm in January 2024, oversees a company which operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK, and the U.S.
“We have done quite well in 2024 partnering in oral solids, sterile fill/finish and with our bio business,” Behar said. “We are partnering with eight out of the top 10 pharma and are more or less ranked number five today in the CDMO industry.”
Behar contends that Recipharm last year “sharpened” its global network, which includes 17 facilities worldwide, and has become a “more agile” company. Targeted investments in 2024 included the expansion of small molecule development capabilities at Recipharm’s center of excellence in Bengaluru, India, with a new sterile product lab.
Last month, Recipharm’s ReciBioPharm — which works with customers to develop and commercialize advanced therapy medicinal products (ATMPs) — was awarded a three-year grant from the Bill & Melinda Gates Foundation to support the global deployment of RNA continuous manufacturing technologies to low- and middle-income countries.
In January, Recipharm also teamed with Quebec-based Spektus Pharma to jointly develop and supply a portfolio of novel central nervous system-focused products using Spektus’ proprietary Flexitab oral drug delivery platform. The two companies will initially target the growing antidepressant market.