Shutterstock
We at EPM HQ heard from Vincenza Pironti, PhD, Strategic Marketing Director, and Ramesh Jagadeesan, Vice President, Analytical Development, at Recipharm to get their thoughts on the outlook for the world of pharma throughout 2024.
The Desire to Overcome Various Issues and What the Outlook is for Global Pharma in 2024
Vincenza Pironti, PhD, Strategic Marketing Director, Recipharm:
The global biopharmaceutical market is projected to be worth $856.1 billion by 2030, up from $333.1 billion in 2022. This impressive growth is being driven not just by increasing demand for existing biologics, but by accelerating rates of development of innovative new treatments for rare and orphan diseases.
However, keeping up with this demand poses challenges. For instance, they need to consider ways of filling large volumes of individual doses, while ensuring sterility and optimising manufacturing efficiency. They also need to consider how they can improve product distribution, particularly to markets a long distance from the manufacturing site. Biologics are often costly, and companies can ill afford product waste due to breakage.
One option is to explore alternative container options to streamline manufacturing and address logistical challenges. Blow-fill-seal (BFS) containers, for instance, can offer cost-effective sterile fill & finish at high volumes. As they are made from polymers, BFS containers have a low risk of breakage, ensuring that biologics can safely reach their final destination. The composition of BFS containers also allows for single-dose manufacturing, minimising drug wastage from expired drugs left in multi-dose containers.
In the past, BFS was unsuitable for biologics, due to the high temperatures involved in traditional manufacturing techniques. Recent advances allow drug formulation temperature to be factored into BFS manufacturing, meaning such formats are now promising for the aseptic filling of biologics.
Navigating the Regulatory and Analytical Landscape in 2024 and Beyond
Ramesh Jagadeesan, Vice President, Analytical Development, Recipharm:
Analytical testing plays a key role in producing qualitative and quantitative evidence that an oral solid dosage (OSD) drug is safe for use while providing insight into product potency, efficacy, and quality. A comprehensive understanding of these attributes is vital to bringing therapies to market in this highly regulated industry, with regulatory agencies requiring extensive analytical data as part of the drug approval process.
However, the emergence of increasingly complex active pharmaceutical ingredients (APIs) has resulted in an estimated 70-90% of drugs currently under development being poorly soluble. This has not only added complexity to OSD formulation but also the development and validation of suitable analytical techniques to determine the drug’s effectiveness and safety.
As we move into 2024, overcoming the challenges surrounding the analysis of increasingly complex formulations will rely on specialised, comprehensive, and innovative analytical development. OSD developers and manufacturers must follow a robust strategy for designing fit-for-purpose analytical methods to resolve issues, such as those related to sample preparation and reproducibility. A robust strategy will encompass:
- An extensive literature search to identify tests that could provide the required information about a drug substance or product.
- Compound characterisation using standard techniques.
- Selection of the appropriate analytical technique for the characteristic or functional information.
- Definition of the analytical target profile.
- Identification of the critical method parameters.
In addition to adopting robust analytical method design strategies, OSD producers must continue to leverage advancements in technologies and equipment providing new possibilities for more in-depth testing during drug development. This could include the adoption of technologies like inductively coupled plasma optical emission spectroscopy (ICP-OES) to identify trace elements within drug formulations. With this approach, developers and manufacturers can ensure their OSD drug meets increasingly stringent regulatory standards.