ChemPartner
A True Pharmaceutical Alliance Partner

The timeline between nominating a compound as a New Clinical Entity (NCE) and ultimately marketing the drug on a commercial scale has remained the same for decades—typically five to six years. However, in the biopharmaceutical marketplace, a company called ChemPartner—through its Chinese subsidiary, China Gateway—is innovating the process. After realizing that both the discovery and Chemistry, Manufacturing & Control (CMC) Development activities needed to be done more effectively, particularly for companies who may not have internal capacity for these activities, ChemPartner changed the game.

As a Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO), ChemPartner has helped hundreds of customers discover and develop their NCEs. ChemPartner has helped to identify improved manufacturing processes to help its clients enjoy significant cost savings. For example, one of its clients required the Cost of Goods (COGS) target for a Registration Starting Material (RSM) to be significantly less than the initial COGS estimated in early development. To make the drug commercially viable on the marketplace, the client needed to decrease the COGS for this RSM by a factor of two or more. This particular RSM was actually manufactured from two earlier advanced intermediates with a total of 18 chemical steps. “We worked with the client toward improving the manufacturing processes for these compounds. At each of the 18 steps, we identified and developed better choices of reagents, catalysts, solvents, and stoichiometry, and we improved the unit operations. Today, we have a long-term supply contract to manufacture this key RSM as well as another RSM, simply because we achieved a significant reduction in their COGS and have proven to be a reliable partner,” explains Donald Hou, Senior Vice President at ChemPartner and a thirty-six year pharmaceutical industry veteran.

Similar to the aforementioned example, ChemPartner aids a host of customers, ranging from big pharma firms to small virtual biotech companies, in optimizing the manufacturing processes for both small and large molecules. Be it process development, pre-formulation development, analytical method development and validation, or CMC CTD support for regulatory filings, ChemPartner’s 500+ CMC team of chemists, engineers, quality control, quality assurance, plant operational, and support staff is equipped to accomplish the research development and non-GMP and GMP manufacturing initiatives of pharma and biotech companies across the world.

We cover everything related to a new clinical entity’s discovery, production, and regulatory processes, and we have evolved into a one-stop solution provider for both small and large molecules

While it started out in the discovery/CRO segment, the organization has grown leaps and bounds as a CDMO since entering the CMC development space in 2007. Today, ChemPartner is uniquely positioned as both a CRO and CDMO. “We cover everything related to NCE discovery, production, and regulatory processes, and have now evolved into a one-stop solution provider for the pharmaceutical and biotechnology industries,” adds Hou.

To ChemPartner, the company slogan, “Your True Pharmaceutical Alliance Partner,” isn’t just a fancy catchphrase. ChemPartner works in close partnerships with clients to understand their requirements and COGS targets before determining if the processes are sustainable to develop the drug commercially. “We pay close attention and work with our customers and help them achieve their development/ project objectives including obtaining the targeted COGS,” explains Hou. To create transparency and avoid “surprises,” ChemPartner establishes open lines of communication and provides clients with a Gantt chart so every step of the development process is closely monitored and allows for adjustments to be made as necessary.

These are exciting times for ChemPartner, as they recently extended biologics capabilities including monoclonal antibodies and antibody-drug conjugates (ADCs) with the overarching goal to “develop safe, robust CMC manufacturing processes at a satisfactory cost point.” This year, ChemPartner is in the process of launching a new CMC Biologicals GMP facility in Qidong, located north of Shanghai. The CDMO will also be adding CMC small molecule commercial GMP manufacturing capabilities at the Fengxian site (located in Shanghai) by the year 2021, with plans of doubling its current manufacturing capacity.