De-risking generics pathways in high-potency programmes

Demand for generic drugs continues to grow around the world.
This presents opportunities for pharmaceutical companies as well as patients seeking life-changing therapies. The U.S. remains the largest market for generics globally, making it a strong target for drug developers looking to introduce in-demand treatments for cancers and immunological diseases.
Drugs with highly-potent active pharmaceutical ingredients (HPAPIs) are very effective in these areas of medicine, due to their ability to achieve a powerful therapeutic effect, even at smaller doses.
However, fierce international competition, as well as the need to secure regulatory approval and reach the market first, means that designing processes in the right way is integral to the success of a programme. 

Securing first-mover advantage in generics development

The process for approving a novel drug can be time-consuming and costly. Drug developers must carry out a wide range of studies proving safety and efficacy. It is a process that can often take more than a decade.
However, some markets offer generics developers the opportunity to reduce this timescale by using existing preclinical, clinical and safety studies. Pathways such as the abbreviated new drug application (ANDA) in the U.S. are available to developers who can demonstrate that the generic is bioequivalent to the original drug, and has the same active ingredient, strength, dosage form and route of administration.
There are considerable financial advantages to reaching market first, but developers who wish to gain approval must demonstrate reliable, repeatable processes and compile a package of extensive and trustworthy data.

The extensive requirements of high-potency active pharmaceutical ingredients
This pressure is even more pronounced when HPAPIs are involved. HPAPIs require careful handling, with controls to prevent cross-contamination. Containment and cleaning systems must be in place to ensure the stability of the API and the safety of workers.
The entire process must align with requirements such as the European Union’s good manufacturing practice (GMP) guidelines, which place heavy emphasis on good risk management and toxicological rationale. These processes must perform reliably, even when development scales up to higher volumes.
When a developer partners with a contract development and manufacturing organisation (CDMO), high-quality, seamless tech transfer becomes essential. If teams do not align expectations, standardise processes and address product knowledge gaps at the outset, there is a risk of discrepancies and costly delays.

Improving the likelihood of regulatory approval 

To meet these standards, it is important to carefully consider factors such as facility design, containment and data collection in the HPAPI production process. This can be facilitated by engaging with a trusted partner with experience in the HPAPI space.
Here are three areas that developers and their partners should consider from the outset: 

Process and facility design 

HPAPIs must be produced in a repeatable and reliable manner. This includes closed transfer methods that prevent exposure risks and product loss, as well as units that reduce cleaning time and the need for manual checks. Automation and digitalisation can also be employed to minimise containment risk and improve efficiency. 

Tech transfer 

While partners can be invaluable in helping to meet demand, inefficient tech transfer can result in misaligned manufacturing processes, discrepancies in product quality and potentially costly delays. Processes must be mapped out beforehand, with a clear understanding of exposure limits and containment requirements. Risk assessments and checks should also be carried out to ensure the process and output meet expectations. 

Data gathering 

Generics developers are expected to collect and submit data with a high degree of rigour and accuracy. It is crucial to understand the data requirements of regulators in each market and to ensure that processes for gathering this data are established from the outset.

How Recipharm ensures predictable performance and transfer-ready data 

Recipharm is a specialised high-potency CDMO, whose end-to-end approach allows generics developers to move efficiently from development to manufacturing. 

Generics developers benefit from: 

Specialist expertise 

Our knowledge of HPAPI programmes enables us to develop optimal processes for HPAPI handling and to advise on ways to improve quality and speed up time-to-market. We make sure our processes align with regulatory requirements and work with partners to design programmes with compliance in mind. 

State-of-the-art facilities 

We have invested extensively in purpose-built high-containment facilities that deliver the required quality consistently, even as batch sizes increase.

Effective tech transfer 

By working across development, scale-up and manufacturing, we deliver a unified process that allows customers to spot misalignment, locate efficiencies and develop an inspection-ready, reliable supply of products. 

Data-driven processes 

Tools such as our own ReciPredict™ platform enable partners to get a clearer picture earlier in the process, using data to make adjustments, improve process transparency and produce more complete information for regulators. 

Efficient delivery 

Our specialist expertise and capabilities enable our partners to produce inspection-ready HPAPIs at scale, with 95% right-first-time and 93% on time delivery. Our approach can reduce development timelines by up to 6 months.

Looking for a partner to deliver on your HPAPI requirements? Read our white paper to learn more about how Recipharm can help deliver scalable, consistent supply.
Download the white paper