Trends in Oral Dose Manufacturing: Potent Handling at Almac

Oral solid dosage forms (OSD) have been the most used and favoured dosage form due to their convenience, stability and patient compliance. However, the landscape of oral dose manufacturing is facing rapid growth and evolution due to the increased demand for pharmaceutical companies to cater to diverse patient demographics and preferences.

Technological advancements play a part in this evolution. Innovations including automation and continuous manufacturing are transforming production methods, which means high-quality standards, reduced production costs and the possibility for manufacturers to adapt to market demands.

One of these trending demands is high-potency drugs. Known for their high level of biological activity at low doses, these treatments have been highly effective across various therapeutic areas including oncology, hormonal imbalances and neurology. As such, they have become crucial for treating severe and life-threatening conditions. There are various benefits to high potency drugs or high potency active pharmaceutical ingredients (HPAPIs).

Such benefits include:

• • Targeted therapy
  • Reduced dosage requirements
  • The ability to target damaged cells more precisely whilst sparing healthy tissues

However, it is worth considering that due to the nature of HPAPIs, the production processes of these drug products require specialised facilities, equipment and stringent safety protocols to prevent cross contamination and protect operators.

Almac Pharma Services has a wealth of experience working with potent compounds with an occupational exposure level (OEL) down to 0.05μg/m3/8hrs.  As such, we continuously invest in state-of-the-art facilities and regular training to ensure operator safety while handling these potent substances.

Regulatory agencies such as the FDA and EMA have established guidelines to ensure the safe production of high potency drugs, and manufacturers must comply with these standards to ensure product quality and safety. At Almac, quality assurance and compliance are at the heart of everything we do. We follow strict regulatory guidelines to ensure pharmaceutical drugs are developed to the highest quality and safety requirements.

The role of CDMOs in potent handling

Contract Development & Manufacturing Organisations (CDMOs) like Almac play a fundamental role in helping pharmaceutical companies develop and manufacture high potency drugs.

To meet industry demands for high potency pharmaceutical drugs, we utilise state-of-the-art facilities to optimise our potent handling processes. For example, all equipment in our newly opened 100,000ft2 commercial manufacturing facility is equipped with state-of-the-art isolators and containment systems, allowing our operators to dispense, blend and mill in a fully contained manner. In addition, all equipment in the facility is equipped with wash-in-place (WIP) technology with the aim to minimise operator exposure to the API and prevent cross contamination.

While pharmaceutical companies will benefit from the technical expertise of CDMOs when navigating the complexities involved in manufacturing high potency drugs. CDMOs are also taking advantage of digital transformation to stay at the forefront of innovation and accelerate timelines, with the shared goal of delivering treatments to patients faster.