OCTOBER 202419TECH OUTLOOKThe European pharmaceutical contract development and manufacturing organization (CDMO) market is expanding rapidly due to increased pharmaceutical demand, rising healthcare expenditure, and the advent of disruptive technologies. To succeed in this market, manufacturers must ensure that their facilities, processes, and equipment adhere to strict regulatory requirements and standards, guaranteeing product safety and efficacy. Moreover, they must adopt a continuous improvement mindset to address the specialized equipment and manufacturing processes needed for targeted therapies.Axplora, a company specializing in developing and upscaling complex API production processes, tackles these challenges effectively. Axplora has facilitated FDA approval for 13 new customer drugs in the past five years and is a dependable and agile partner for process development and API manufacturing. The firm has adapted its facilities to handle increasingly complex molecules and invested in new continuous technologies such as chromatography, electrochemistry & flow chemistry. "With our outstanding team of over 120 process development experts and 20 dedicated project managers we provide expertise and service excellence. We have an impressive track record, demonstrated by our successful transfer and validation at scale, of a complex, multi-step API within six months," says Jean Bléhaut, CDMO BU President, Axplora.The firm's expertise in hazardous chemistry enables it to use energetic reagents and chemicals to yield efficient synthesis routes with fewer steps and a lower mass intensity. Axplora is recognized as a leader in the manufacture of antibody-drug conjugates (ADC) and steroids, also leveraging technologies such as HPAPIs and cryogenic chemistry. Following the merger of Farmabios, Novasep, and PharmaZell, Axplora offers unique end-to-end solutions in managing API lifecycles from the clinical phase to post-patent generic life. Having an API network of seven cGMP manufacturing sites across Europe and two in India, as well as a development lab in the US, Axplora ensures quality manufacturing under US, EU and other regulations. The company provides comprehensive services to transition customers' developmental API processes to commercial operation. It evaluates the customer's existing strategies for safety and robustness, optimizes the chemical process including reducing its environmental impact, and develops and validates analytical methods for release. During the technical transfer, the firm thoroughly assesses the process and performs process analytical development to ensure suitability for GMP production of clinical API supplies. Once validated, the process is used to manufacture commercial API products on an industrial scale. A leading big pharma company recently hired Axplora for a project that required a transfer of the process, followed by commercial production of an API for COVID. The entire team rose to the challenge and completed the multi-step synthesis from the letter of intent to process validation in six months at the large-scale site in Mourenx. It was a noteworthy accomplishment, as the job usually takes 12 to 18 months. The success can be attributed to the well-structured project governance system and parallel activities enabled by quickly mobilised resources and close collaboration with its customer.Acknowledging the importance of environmental, social, and governance (ESG) practices, Axplora has initiated carbon reduction programs and launched a global ESG roadmap to offer greener solutions for the pharmaceutical industry. The company also prioritizes employee skill development through its internal university, providing various training opportunities in, among others, management, sales, project management, and presentation skills. With our outstanding team of over 120 process development experts and 20 dedicated project managers we provide expertise and service excellenceJean Bléhaut, CDMO BU President Agile Partner for API Process Development and Manufacturing Innovative API Manufacturing
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