Newsletter | September 13, 2023

09.13.23 -- Ensure HPAPI Safety And Quality With The Right CDMO Partner

How To Select The Ideal HPAPI Manufacturing Partner

As you begin the journey to manufacturing your highly potent active pharmaceutical ingredient (HPAPI) therapeutic, consider what you need in a CDMO partner. An experienced manufacturer will have thoughtful recommendations on process, equipment design, and employee training, ensuring that a safe, high-quality therapeutic reaches the patient.


Prioritize Safety And Mitigate Risk In HPAPI Manufacturing

To safely manufacture HPAPIs, there are three key factors that manufacturers must prioritize: strong containment strategies based on designated occupational exposure levels (OELs), thoughtful process development and familiarization, and a team of highly trained, experienced personnel to handle the product.


From Bench To Batch: Strategies For Scaling HPAPI Production

HPAPIs have become increasingly popular, as they tend to be more targeted and cause fewer side effects due to their low dosage. However, highly potent materials bring additional challenges to manufacturing processes. Examine considerations for optimizing HPAPI production methods to reduce risk and deliver therapies to patients with speed.


Implement A Risk-Based Approach To Safely Manufacture HPAPIs

Designing a therapeutic with a highly potent active pharmaceutical ingredient (HPAPI) has the potential to reap major benefits for patients in need, including those diagnosed with cancer. To successfully reach patients, identify a manufacturing partner with the experience and knowledge needed to bring your product to market safely and effectively.


The Paradigm Shift To Continuous Flow Processes: A Holistic View

The need for continuous flow manufacturing continues to grow, as it offers a number of important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process. Explore dangerous chemistries and continuous flow processes for the manufacture of safe, efficacious, cost-effective products.



Small Molecule APIs: From Pre-RSM To Final API

Ajinomoto Bio-Pharma Services has over 40 years of experience providing high-quality APIs and intermediates. Our chemists are leading experts in organic chemistry and our advanced facilities provide the capacity and quality systems to meet your small molecule APIs and intermediates needs.

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