Highly potent active pharmaceutical ingredients (HPAPIs) are at the forefront of pharmaceutical manufacturing. They are particularly common in targeted therapies and personalized medicines. This is primarily due to their potent therapeutic effects at low dosage forms.
High-potency APIs present countless opportunities in the field of novel drug development. However, developing and manufacturing effective HPAPIs presents a variety of challenges.
There is no global standard on safety and quality protocols in HPAPI production. However, the regulatory landscape is shifting. For example, the majority of companies follow ISPE Guidelines in relation to particular containment performance.
As a base requirement, companies should abide by rigorous standard operating procedures (SOPs), which include containment strategies, employee training programs, quality systems, and more. Despite the inherent challenges, there are now more groundbreaking, highly potent APIs in drug development pipelines than ever before.
Highly potent compounds were initially confined to oncology research areas as they demonstrated restricted applicability for drug products beyond cancer treatment due to their limited specificity. The situation has since changed, and novel drug delivery systems, such as antibody-drug conjugates (ADCs), have paved the way to highly targeted therapies.
They can deliver outstanding efficiency while mitigating some side effects of cancer therapies. Many commercial aspects amplify this improved efficacy, too.
Companies can produce HPAPIs with elevated levels of pharmacological activity using reduced volumes of active ingredients. This emerging market is anticipated to reach $32 billion by 2028, signifying a broader transition toward more efficacious and fine-tuned treatment regimes.
Challenges of HPAPI manufacturing
Containment
Image Credit: Powder Systems
HPAPI manufacturing and development places extra emphasis on containment. This is a key feature to ensure personnel safety, environmental protection, and regulatory compliance. Occupational exposure limits (OEL) for HPAPIs are considerably low, which asserts that exposure to even tiny volumes can present severe health risks to workers. Moreover, the risks and dangers of cross-contamination with other products cannot be ignored.
Isolated manufacturing zones designated specifically for high-potency products are crucial for HPAPI handling. These zones are engineered to the highest standards to prevent the migration of hazardous particles to non-designated areas. Specialized equipment, rigorous protocols, and stringent facility design are part of the engineering controls of containment zones. Key measures include:
- Closed systems
- Dedicated air handling units
- High-efficiency particular air (HEPA) filtration
- Stringent decontamination protocols
Planning well defined zones, limiting personnel movement, and using state-of-the-art containment technologies highlight the industry’s commitment to ensuring the safe handling of potent compounds in commercial manufacturing of new drug systems.
Scalability
Scalability presents an additional challenge as early molecule discovery must translate to a workable commercial product. This demands powerful equipment suitable for scaling, as well as strong relationships with outsourcing partners.
The potency and high value of HPAPIs present a variety of manufacturing scales and batch volumes when compared to APIs. Meeting market demand generally requires fewer volumes and smaller batches to minimize financial risk related to batch loss.
Outsourcing decisions
Outsourcing HPAPI manufacturing can help manufacturers overcome the many infrastructural challenges. However, making this decision is more complex. In-house manufacturing requires major investment in specialized facilities and equipment, as well as a commitment to maintaining compliance with continuously evolving regulatory standards. Burdens can be alleviated by outsourcing to contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs).
However, outsourcing does not mean there is no risk. The main concern is selecting competent CMOs or CDMOs with demonstrated proficiency in safely handling highly potent compounds.
HPAPI manufacturing is by nature a complex process, which necessitates a great understanding of how to properly handle potent substances.
Moreover, compliance with developing regulatory standards, ensuring rigorous quality control measures are implemented, and safeguarding intellectual property are also major challenges. Companies may, for instance, decide to carry out in-house R&D but transfer commercial production to the CMO.
On the other hand, a CDMO may initiate the research to allow the company to prepare and open its manufacturing site. The integrity of the production chain is becoming progressively more important in HPAPI production, as various stakeholders need the right equipment working in tandem.
These challenges highlight the need for careful planning, clear contractual agreements, and the selection of a dependable outsourcing partner when considering outsourcing HPAPI manufacturing.
Seizing the opportunities
Market growth
The upswing recently anticipated in the HPAPI market presents a great opportunity. This growth is supported by the increased demand for targeted therapies and personalized medicine, wherein HPAPIs play a key role due to their potent therapeutic efficacy.
This is a significant commercial opportunity influenced by the potential to command premium pricing due to the specialized nature of HPAPIs. Furthermore, the growing prevalence of chronic ailments further catalyzes this demand, ushering in a new revenue stream for HPAPI manufacturers.
New emergent HPAPI manufacturing technologies signal a new era of progress and efficiency in pharmaceutical development. These breakthroughs, which range from novel containment solutions to automation and real-time monitoring systems, are crucial when it comes to facing the inherent challenges HPAPI manufacturing presents.
By facilitating precision control over the manufacturing process and minimizing contamination risk, these technological strides boost operational efficiency and move the industry closer toward the required safety standards.
About Powder Systems
Powder Systems Limited (PSL) provides a full range of solid liquid separation solutions for filtration, drying, and processing from research and development activities up to larger commercial production scale. Quality and innovation are central to everything they do. They are proud of their award-winning track record and have been working with industry partners for over 35 years. PSL supports clients by developing solutions to overcome challenging manufacturing processes and provide first-class aftercare services.
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