Top 10 late phase considerations

Late phase commercial development and manufacturing

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Successfully navigating clinical trials is an exciting milestone for pharmaceutical and biotechnology organisations,

with just around 10% of products entering clinical trials receiving commercial approval.

Launching a product for commercial sale, however, is not without its challenges. During their project’s late stages, organisations must address uncertain demand, stringent compliance requirements, quality control, waste management and many other variables.

To prepare their product for launch and continually meet commercial demand, it is critical for organisations to select an outsourced partner with a long track record of cGMP manufacturing expertise and a commitment to continual innovation.

Discover how the right partner can help you address ten key challenges organisations face during their projects’ later stages.

1 | New drug application

Prior to commercialisation, organisations must submit a new drug application (NDA) to regulatory authorities detailing their product’s safety, efficacy,

manufacturing details and much more.

The right partner will assist in compiling key portions of the new drug application, ensuring that no detail is missed to satisfy the detailed requirements of regulatory agencies.

New drug applications can take transfers take 6-10 months to review and approve.

2 | Scale-up challenges

Scaling up a project may necessitate significant process changes to achieve the necessary levels of safety, quality, purity and efficiency. An outsourced partner should have a strong track record in API manufacturing, positioning them to identify the most efficient and cost-effective path to success and work to skill fully overcome any unforeseen challenges along the way.

Over 80% of pharmaceutical organisations outsource manufacturing processes.

3 | Risk mitigation

The pharmaceutical industry is notoriously risk-averse, and in addition to ensuring that people and processes are safe, manufacturers must consider factors like intellectual property, supply chain stability, and potential ﬁnancial impacts.

The right outsourced partner should deliver the expertise and guidance to not only minimise process hazards, but also to mitigate other key areas of risk.

Risk-sharing agreements between pharmaceutical manufacturers and outsourced partners are growing at a rate of 24%.

4 | Process improvement

Throughout a project’s duration, organisations should ensure that they are using the most efficient and cost-effective processes possible while maintaining high quality. A partner should continually seek opportunities for process optimisation, improving efficiency and economies of scale for the customer in order to maximise profitability and commercial success.

Design of experiments is one of the top 10 services that pharmaceutical organisations expect to more heavily outsource.

5 | Demand planning

Demand planning can be a key challenge for pharmaceutical organisations as they commercialise their products, with uncertainty around long-term demand and the potential for unplanned shifts in supply requirements. The right partner will aid in production planning, and ensure that all processes have the flexibility and scalability needed to adapt to demand fluctuations.

46% of pharmaceutical supply chain leaders desire more visibility into possible disruptions.

6 | Emerging technologies

As therapeutics continue to rise in complexity, organisations are seeking to apply technologies like continuous processing and biocatalysis to realise greater efficiencies in manufacturing. The right partner will demonstrate a commitment to technology and innovation, with proven experience harnessing innovative technologies at scale in customers’ programmes.

95% of biopharma organisations are prioritising new and innovative products.

7 | Quality control

As a project moves from a smaller scale to commercial-scale manufacturing, it is important to adhere to increasingly rigorous quality standards. An outsourced partner should ensure continued adherence to stringent quality controls, with an experienced quality control team that is dedicated to affirming the product’s ongoing safety, purity and efficacy as quantity increases.

Pharmaceutical professionals cite quality issues as the top deficiency that would prompt them to switch outsourced partners.

8 | Regulatory compliance

Compliance is imperative throughout the entire molecule lifecycle, but especially so as a product reaches the market. A partner should have established expertise in cGMP manufacturing, with a proven track record of regulatory inspections. It is also critical that a partner supplies the necessary supporting evidence in the wake of any process changes.

65% of pharmaceutical manufacturers outsource regulator services.

9 | Collaboration and transparency

Consistent communication is imperative to ensuring manufacturing goes smoothly and that all requirements are met. To maintain close alignment on production planning, process changes, opportunities for improvement and more, organisations should select an outsourced partner known for proven collaboration and partnership.

Nearly all pharmaceutical organisation cite integrity and communication as top qualities to look for in an outsourced partner.

10 | Sustainable waste management

Large-scale manufacturing can generate a substantial amount of waste, including hazardous waste, and it is important to ensure that all types are properly managed. An outsourced partner should show a commitment to mitigating its environmental footprint by minimising the amount of waste produced, recycling wherever possible, and properly treating any remaining waste.

1 in 4 pharmaceutical organisations have set goals to reduce waste-related emissions by 25% or more.

Flexible and scalable manufacturing to maximise commercial success

Ensuring continued project success as you prepare for commercialisation requires the right partner. With more than 50 years of expertise in API manufacturing, at Sterling we have the equipment, cGMP capabilities and expert engineering teams needed to seamlessly scale-up projects. As a PDMO, or partnership development and manufacturing organisation, we also serve as true partners to our customers, maintaining close collaboration as we help them navigate the many complexities that come with commercialisation.