Advanced Technologies Unlocking the Future of Drug Manufacturing
As the manufacturing landscape changes, it opens the door to pursuing hybrid opportunities that push the boundaries of technological advancement in the field. As an Industry Leader in two key domains: flow chemistry and biocatalysis, Asymchem has developed an innovative manufacturing approach that synergizes both: flow biocatalysis, offering a compelling alternative to traditional solid-phase chemical methodologies for more complex architectures, like peptides and oligonucleotides.
Proactive on Sustainability & Risk Mitigation
Finding the right partner for flow chemistry and biocatalysis solutions addresses sustainable and chemical technology aspects of pharmaceutical projects that enable drug manufacturers to benefit from
- A higher quality
- Access to novel chemical structures
- Performance of novel transformations or reactions not practical to implement at large scale in batch mode
- Increased resources, time, and reduced cost savings.
Traditional chemical manufacturing, whether geared toward drug substances, cosmetics, lubricants, or other products, invariably entails hazards that demand meticulous management to safeguard employee health and safety. Contrastly, Asymchem has developed a scientific mechanism for evaluating safety risks, diligently implemented as processes move from laboratory-scale experimentation to progressively larger scales.
A Sound Non-GMP Sourcing Strategy & Regulatory Compliance
Navigating the landscape for non-GMP manufacturing is considerably more exclusive and poses unique challenges in conducting due diligence. There is an inherent risk associated with non-GMP supply chains as it is not uncommon for such non-GMP-focused companies to face sudden closures due to bankruptcy or manufacturing incidents. Consequently, emphasizing risk mitigation in the context of non-GMP materials cannot be overemphasized. Solutions like Asymchem’s make versus buy analyses enable distinctions between raw materials suitable for procurement and those better suited for in-house manufacturing. This determination hinges on multiple factors, including the number of suppliers, the extent of familiarity Asymchem has with these suppliers, and their reputation for being high-quality and dependable.
The fundamental measure of compliance lies in adhering to GMP requirements. The extent to which a CDMO rigorously implements its quality system serves as the litmus test, often best manifested through an extensive track record of outstanding regulatory performance. Most CDMOs are focused on medicinal chemistry, prioritizing the swift synthesis of compounds for early-stage studies with scant attention to process efficiency and sustainability. In stark contrast, acting as a process R&D and manufacturing company enables the acquisition of big pharma clients right from inception.
Working with a trusted CDMO for innovation and acceleration
One of the reasons that Asymchem is so focused on technology is that technology is borderless. In its capacity as a CDMO, Asymchem delivers tangible drug substances, complimenting the pursuit of cutting-edge technology that fosters the generation of invaluable knowledge.
The true essence of Asymchem which crafts these assets and serves as the cornerstone of its offerings starts in China. Key differentiators of Asymchem’s flow biocatalysis for manufacturing include:
- Profound commitment to environmental risk management, working exclusively with materials that can be disposed of responsibly.
- Meticulous selection of prospective vendors for non-GMP manufacturing, while also qualifying themselves as a supplier for unexpected disruptions
- Constant generation of novel opportunities for innovation and enhancement — opportunities that might elude those with less advanced capabilities.
Explore more about flow biocatalysis with Asymchem here!