GHP Q3 2021

46 GHP / Q3 2021 , Jul21181 Efficient CDMO Services Chime Biologics provides client-centric and cost-effective services for timely premier-quality biopharmaceutical development andmanufacturing. The Chime single-use facility supplies drug substances and drug products tomore than 20 countries and is compliant for all major markets including US, Europe and UK. It also supports clients looking for a strategic local partner for the Chinamarket. Named Best Contract Development andManufacturing Organisation 2021 – China by Global Health & Pharmamagazine, we profile the company to find out more. Chime Biologics is a world-class contract development and manufacturing organisation (CDMO) that has delivered more than 30 programmes compliant with FDA, EMA, NMPA, and more than 20 other regulatory authority requirements. It is proud of its record for quality, compliance, bioprocessing expertise, and cost-effectiveness. The experienced team has successfully delivered CMC, DS and DP process development and GMP manufacture programmes including mAb, bsAB, fusion proteins, and conjugated proteins, and they are available to discuss how best to support priority programmes. Most biotechs do not have their own process development and manufacturing capabilities and will outsource to development and manufacturing partners. Chime has several clients operating a virtual model, as well as multiple clients using its facilities as additional capacity, either for drug substances, drug products, or both. In some cases, clients use Chime’s services to supply specific markets and to de-risk their supply chain. Chime began operating its current state-of-the-art facility in 2013 and during its construction, built a core senior team with international experience in biologics process development and manufacture. This included process and analytical testing and characterisation experience as well as quality and regulatory function experience. Within the last 18 months, Chime’s staff have adjusted to remote working, since travel was impacted throughout the world due to the COVID-19 pandemic. This was done using technology such as Microsoft Teams and Zoom for remote site tours, technical and quality audits, and to allow remote person in plant where possible. COVID-19 has been the focus of many companies for vaccine and therapeutic product development. The majority of these processes are reliant on single-use technology, making supply a potential constraint to development timelines. Chime has supply agreements with major single-use suppliers and has invested heavily in critical inventory to have immediate availability. Chime has also developed back-up single-use suppliers as a contingency to maintaining critical programme milestones. Chime recently signed a commercial manufacturing agreement for a potential COVID-19 therapeutic to supply global markets outside the US. Other clients have come to the company for development of products that are not for COVID-19 but need to be transferred out from internal capacity or from other CDMOs in order to keep momentum in multiple programmes in parallel. In this short term, this trend is likely to continue and Chime wants to offer support for development where a process has yet to be established or for GMP manufacture where a process already exists. Meanwhile, Chime has a number of exciting plans ahead. Firstly, it has started construction of its GMP-2 facility on its existing site. This is in direct response to capacity demand for clinical and commercial manufacturing capacity. This includes expansion of its MSAT capacity to support process characterisation and process qualification activities. Also, Chime is investing in a new bioprocess innovation centre which will formalise its research and development process and expand its capabilities for this function. Alongside this, it has launched The Chime Innovation Center to address a client need for cell line engineering and development. Many of its existing clients already have cell lines at MCB stage when Chime begins collaboration, however some collaborators need a new cell line to produce a new product for development or want to change to a more productive cell line before late stage development. Finally, chime has announced the expansion of commercial manufacturing capacity on a new bigger site. This will ensure it can scale up and grow with its existing clients and have capacity for new clients who need manufacturing capacity supply or for local support in China. Company: Chime Biologics (Wuhan) Co. Ltd Contact: Vincent Liu Email: [email protected] Website: