While some HPAPIs are cytotoxic, others pose risks through different mechanisms, such as disrupting cell growth or causing harmful biological effects. These factors make handling cytotoxic drugs and HPAPIs a safety-critical operation.

Biopharma Group offers comprehensive support for your HPAPI projects, from early-phase development through to clinical trial supply. Whether you have a temperature sensitive drug substance that requires purification through lyophilisation or a drug product, our team can support you. Our advanced containment facilities enable us to provide full safety assurance and regulatory compliance – including GMP guidelines and OEB 6 requirements. With Biopharma Group’s knowledge of cytotoxic and potent molecules, collaborating with our team ensures consistency, quality and speed across all phases of your HPAPI project.

In the early and clinical development of bioconjugates such as ADCs, working with active material can be highly expensive, particularly in considering its manufacturing complexity, required safety measures, and material costs.

With around 80% of ADCs that are currently approved being lyophilised, Biopharma Group’s expertise in freeze-drying makes us uniquely equipped for delivering ADC projects – from R&D to aseptic fill and finish. In addition to saving you money, we also use our lyophilisation experience to develop placebos that precisely mirror the appearances, reconstitution behaviours, and critical temperatures of your original formulations. This provides the data you require, while minimising the use of actual ADCs during early studies, reducing your project costs and improving safety.

Biopharma Group’s specialisation in freeze-drying also enables us to enhance the stability of your product – and to extend its shelf-life – helping you to achieve its full clinical and commercial potential. Our team also delivers similar benefits for ADCs produced in a liquid format.

The manufacturing of PDCs is a challenging process because of their inherent instability. These products are prone to degradation, while being highly sensitive to moisture, pH shifts and temperature changes. PDCs can also be cytotoxic, which means that they often require specialised safety facilities.

Biopharma Group provides end-to-end support for PDCs to answer these challenges – from R&D to aseptic and high-containment manufacturing. Our approach maximises the stability, safety, and scalability of your PDCs, allowing you to move confidently from early development through to clinical supply and beyond.

As the name suggests, substances of non-specific toxicity are characterised by a lack of available toxicity data. Projects that aim to get these first-in-human (FIH) drugs into clinical trials can be complicated. This is because they not only require specialised safety equipment but may also change in scope as datasets shift.

Biopharma Group’s previous work with this product type – and our deep understanding of FIH applications – allows us to swiftly adapt to evolving data and overcome any project challenges that may arise. This flexible approach enables us to manufacture your non-specific toxicity substance on time and to budget.

Biopharma Group is also highly experienced in safely handling highly potent and potentially hazardous compounds. Working within a high-containment and sterile environment, our team ensures that a GMP-compliant approach is applied to all the products we manufacture for clinic.