Known for its competence, responsibility, and innovative capability in chemical supply, Alfa Chemistry recently unveiled its new role as a CDMO service provider for pharmaceutical companies worldwide.
Contract Development and Manufacturing Organization, abbreviated as CDMO, is a preferential way for a majority of pharmaceutical companies to outsource ongoing drug development and drug manufacturing projects.
“With advanced facilities, we are capable of providing CMO, CRO, and CDMO services globally for the design, development, and production of various biologic drug products, including but not limited to recombinant proteins, ADCs, monoclonal antibodies, and bispecific antibodies,” said the Marketing Chief of Alfa Chemistry. “Our technical expertise in biomanufacturing allows us to respond swiftly and solve problems that puzzle our clients efficiently.”
The list of CDMOs services provided by Alfa Chemistry covers nearly every aspect of drug development and manufacturing and is mainly focused on the following areas:
Alfa Chemistry offers customized research services regarding antibody engineering, chemical synthesis, and antibody drug conjugation & screening.
Alfa Chemistry provides a series of integrated contract development services for mAbs, including: antibody humanization, cell line development, upstream process development, downstream process development, formulation process development, ADC process development, analytical method development, standard quality establishment, and stability studies.
Alfa Chemistry provides MCB, WCB, and EOPCB banking services in compliance with European EMA and Chinese NMPA GMP regulatory requirements. In addition, the company is capable of conducting GMP manufacturing at scales ranging from 50 L, 200 L, 500 L, 1,000 L, to 2,000 L for cell culture, linkers, payloads, and complete ADCs. Nevertheless, all productions are monitored by stringent quality management systems.
Besides the above-mentioned services, Alfa Chemistry can also provide insights on navigating complex regulatory processes and advancing client programs from the (pre)clinical to commercial stages.
About Alfa Chemistry
It is universally acknowledged that drug development and manufacturing have no shortcuts. Meanwhile, the complexity of drug development and manufacturing brings about uncertainties, further preventing the success of drug projects. Moreover, challenges may exist in subsequent production scale-up stages where regulations and deadlines must be met. Therefore, an increasing number of pharmaceutical companies are now diverting into new models, that is, outsourcing tasks to CDMO partners capable of providing scientific support throughout the complete drug development and manufacturing process. Among the most reliable CDMOs that strictly keep up with contract requirements and timelines, Alfa Chemistry is ready to step forward for its worldwide customers.