Bringing performance, quality and safety to the pharmaceutical industry

By Kevin Robinson | Published: 4-Oct-2022

Catching up with a trio of industry outsourcing experts, Dr Kevin Robinson explores the key trends have had the biggest impact on the pharmaceutical’s contract service industry in recent times

“The impact of the pandemic cannot be ignored,” states Ben Wylie, Head of Product Management and Marketing at ChargePoint. “This period has seen an unprecedented scale of collaboration between pharma companies, their CDMO partners and equipment vendors. The need to develop vaccines to address COVID-19 saw an influx of investment in the pharma space, particularly to boost sterile manufacturing capacity.” 

“One of the big growth areas and success stories was the validation of mRNA vaccine technology. This required a huge scale-up of manufacturing capacity and logistical effort as the industry was faced with supply chain disruptions, yet needed to mobilise new lines with speed."

"As vaccination programmes persist and the technology is explored in other areas, for influenza virus and in oncology for example, it’s likely that companies will continue to invest in the sterile processing capabilities required to produce such vaccines.”

Bringing performance, quality and safety to the pharmaceutical industry

“Regulations are also evolving, with the latest amendments to Annex 1 of the Good Manufacturing Practice (GMP) guidance set to come into effect shortly. Within the new guidelines, the reduction of manual intervention by line operators is encouraged, with the aim of ensuring safe handling and the reduction of possible contamination.” 

“Similarly, manufacturers are advised to take account of any risks presented by any materials, such as powder products, live organisms and radiopharmaceuticals that pose a biologic or chemical hazard. This could well lead to companies needing to review their existing processes to ensure compliance.”

“An important trend that continues to develop is the adoption of single-use components and equipment,” he adds. “By eradicating the need for cleaning, validation procedures and additional gowning, manufacturers can reduce manual intervention and stay compliant with Annex 1 requirements. It is likely that single-use will see greater uptake in the future as CDMOs invest further in technology that keeps them compliant and improves overall productivity.”

Booming biopharm
“Exponential growth in biopharma is fuelling demand for outsourced capacity, expertise and efficiency,” says Eric Hsu, Account Director, Alliance Management at Samsung Biologics. “The sector’s reliance on contract development and manufacturing organisations (CDMOs) continues to grow as demand for biologic drugs expands around the world.” 

With the global biopharma market projected to reach nearly $900 billion by 2030, demand for these drugs will increase the industry’s reliance on outsourcing owing to limited capabilities and manufacturing capacity, among other reasons.1 Currently valued at approximately $11 billion, the global biologics CDMO market is expected to double by 2027, with CDMOs playing an ever-expanding role in producing the world’s large-molecules.2

Bringing performance, quality and safety to the pharmaceutical industry

“The sudden onset of the COVID-19 pandemic revealed challenges and limitations in the biopharma industry’s critical supply chains,” he continues: “At the same time, the pandemic revealed the benefits of outsourcing to CDMOs that have the technical experience and manufacturing capacity to support drug supply chains.” 

By outsourcing messenger RNA (mRNA) vaccine production to prominent CDMOs, Pfizer/BioNTech, Moderna, AstraZeneca, J&J, Novavax and others were able to manufacture and distribute more than 14 billion doses to the world in less than a year.3 

“Several CDMOs were already well-versed in lipid nanoparticle formulation, a key step in mRNA vaccine production. Also, CDMOs offered the urgent manufacturing capacity needed to deliver life-saving therapeutic treatments to patients. These are the kind of experience and capabilities CDMOs brought to the table and it’s likely that, without these already built-in, the industry’s urgent and prompt response would not have been possible.”

“Manufacturing biologics requires a mastery of technical ability within an aseptic environment to ensure product quality and yield. As growth in biopharmaceuticals continues, outsourcing will continue to play a critical role in the development and production of large-molecule therapeutics."

"Outsourcing allows drug developers to have faster access to newer technologies and methodologies that can accelerate programmes. Samsung Biologics is a prime example of how biologics CDMOs are supporting faster, cost-effective and more sustainable routes to commercial markets and ultimately patients,” he concludes.

Strategic partnerships
“Across the entire spectrum of the pharmaceutical industry the impact of outsourcing has been tremendously positive, especially when it comes to the safe secure supply of medications to patients,” comments Steven Huang, Director of Global Business Development at Bora Pharmaceuticals. “For the first time, the world recognised the critical role that CDMOs play in helping pharma successfully to deliver pandemic vaccines to people at a life-saving pace.” 

Bringing performance, quality and safety to the pharmaceutical industry

“The biggest trend to hit the pharmaceutical industry is how it is relying on outsourcing to develop, manufacture and distribute the vast majority of the world’s pharmaceuticals, especially biologics, and, ultimately, address all patient needs in the most efficient and steam-lined manner.”

“For a vast majority of today’s large-molecule drugs, CDMOs are truly beginning to own the space,” he argues. “Much of pharma, whether it’s developing an investigational new drug (IND) for an oncological application or a faster, less expensive process to manufacture an adalimumab biosimilar, is turning to contract pharma to ensure a faster, less expensive path to markets and patients.” 

“Because of CDMOs’ expertise and advanced capabilities, growth in the sector is accelerating. From sustainable processes to regulatory compliance, pharma is relying on strategic partners to see them through every step of their drug product’s commercial journey.”

“Pressure to reduce the supply chain length and improve lead-time efficiency is prompting companies to increasingly engage external partners to meet the global demand for biologic drugs. This has turned contract manufacturing into an athletic and flexible enabler of these often life-changing drugs.” 

Along with the pace of investment in the development of all biologic drugs, global CDMO capacity is growing. For example, biopharmaceuticals are booming in Asia, bolstered by enhanced regulations, an influx of venture capital, a culture of innovation and government support.

“Although Asian biologics manufacturing has historically focused on biosimilars, it’s now changing as the major regional markets and domestic development mature. Bora, among other leaders in the space, are responding fast, acquiring and expanding capabilities and operations in Asia and North America to produce these drugs at unprecedented levels.”

“Although pharma’s innovation may come from its traditional development paths, delivering these breakthroughs to patients safely and affordably has become the provenance of the world’s biologics CDMOs — and rightfully so given their record of performance, quality and safety.”

References

  1. www.precedenceresearch.com/biopharmaceutical-market.
  2. www.mordorintelligence.com/industry-reports/biologics-contract-development-and-manufacturing-organization-cdmo-market.
  3. www.mckinsey.com/industries/life-sciences/our-insights/on-pins-and-needles-will-covid-19-vaccines-save-the-world.
  4. https://ispe.org/pharmaceutical-engineering/may-june-2018/rise-biopharmaceutical-manufacturing-asia.

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