Porton Pharma Solutions has just opened its new drug development facility in Cranbury, New Jersey, operated under its US subsidiary J-Star Research. With over 40,000 square feet of floor space, this facility is customer built to provide world-leading services in API crystallization/isolation and drug product development from R&D to GMP delivery. It is adjacent to the existing API synthesis facility at the same Cranbury campus. This addition expands the CMC services offered by J-Star from API synthesis further into fully interactive drug substance and drug product (DS-DP) development.
In addition to three modular and flexible drug product GMP suites, also built in are a dedicated spray drying suite, and a Drug Product Intermediates (DPI) suite where our solvent based, unique techniques in the Co-processing Technology platform can improve API morphology or PSD and results in speedier, simpler, and more robust DP process development. The R&D labs are for Drug Product Development, Material Science (solid form screen & selection and pre-formulation evaluation), Crystallization Process Development, Continuous Processing and Potent Compound handling. These labs allow experimentation and delivery processing from sub-mg to multi-kg scale. All the labs and suites are equipped with comprehensive state-of-the-art instrumentation. The unique arrangement, with extensive material-science-based powder characterization and instrument scale-down capabilities also enables material sparing approach to formulation and DP process development.
“With the new drug development facility in New Jersey, we will be able to solve much more and broader challenging problems in support of fast-paced drug development programs. We have already demonstrated that our integrated DS-DP R&D approach effectively facilitates problem solving and speeds up the developmental works. The DP GMP suites and expanded R&D labs allow our services to benefit more drug development programs.” says Dr. Renee Miao, CEO of J-Star Research and Porton USA.
The facility’s global reach is noteworthy too. In addition to the US establishment, Porton has a full range of DS and DP R&D and manufacturing facilities in China. For compounds moving into late phases or commercialization after early development in the US, tech-transfer support by Porton’s US-based experts to its manufacturing facilities in China offers clients a trusted global approach to drug development and manufacturing.
“Our new drug product facility represents a significant step forward in our mission to provide our clients with the best possible service and solutions. We are excited that our expansion will allow us to further work on projects solving technical challenges as a truly global partner in the pharmaceutical industry” – Oliver Ju, CEO of Porton Pharma Solutions.
About Porton Pharma Solutions
Porton Pharma Solutions is a leading contract development and manufacturing organization (CDMO) providing high-quality technical services to the pharmaceutical industry. With a focus on innovation, technical expertise, and problem-solving, Porton is committed to delivering cost-effective solutions to drug development programs. The company’s services include drug substance development, analytical development, drug product development, and manufacturing. For more information, please visit www.portonpharma.com.