Pharmaceutical and Biopharmaceutical Manufacturing Industry Memberships
As part of our mission to remain the foremost microbial biomanufacturing CDMO, Luina Bio supports the following biopharmaceutical manufacturing industry organizations:
Pharmaceutical Manufacturing Partners
We have partnered with Scendea to deliver regulatory support services.
Scendea is a leading product development and regulatory consulting practice for the pharmaceutical and biotechnology industry. Over the past 20 years, Scendea has been involved in over 1,000 development programs. Scendea has team members based in the U.K., Ireland, the Netherlands, and the U.S. This expert team delivers strategic and operational assistance in the fields of quality/CMC, non-clinical/toxicology, clinical/medical, and regulatory support to successfully guide products from early development to marketing approval.
Phage Consultants specializes in prevention and troubleshooting of phage contamination problems in production and laboratory setups. The company offers a range of services including phage and prophage detection, facility audits and initial assessments, consultations, personnel training, advice on bioprocess optimization and new facility development. Since its establishment in 2007, Phage Consultants has successfully completed over 150 phage prevention and troubleshooting jobs and remains a global leader in prevention and resolution of phage-related production irregularities.
Phage prevention depends heavily on extensive and reliable sample testing — Phage Consultants offers routine testing of incoming bacterial strains and cell banks for the presence of both lytic phages and prophages, a service frequently used and highly recommended by Luina Bio.