Ensuring High-Quality Accelerated Biologics Manufacturing
As the pharma industry evolves and advanced therapeutics such as gene therapies and cell-based products gain momentum in the market, the demand for rapid timelines from development to commercialisation is rising. Development and manufacturing speed is critical for drug manufacturers to expedite medicines that have the potential to change patients’ lives. In addition, they need to demonstrate a return on investment to investors to keep developing and driving products forward.
Optimising development and manufacturing processes to accelerate biologics production while keeping costs down is essential to meeting market demand. Streamlining drug product (DP) manufacture helps to shorten timelines for biologics production, but this process requires expertise and experience.
In this article, Jinhyeok Jeong and John Thomas, Senior Directors of DP Inspection & Packaging and DP MSAT, explores the major areas of DP manufacturing that can accelerate timelines from development to commercialisation, along with the necessary qualities that should be sought after in a specialist service-providing partner.
The Need for Speed to Market
In the highly competitive biopharmaceutical industry, bringing a product to market at speed positions an organisation for commercial success and ultimately helps improve patient outcomes as quickly as possible.
On-time delivery is of the utmost importance. Clients need to be competitive by reaching the market fast. For healthcare professionals, on-time delivery of therapeutics is essential to facilitate seamless healthcare planning and, importantly, continuity of care. Finally, and perhaps most significantly, for patients, quick access to life-changing therapies can improve outcomes and prognosis.
However, bringing a drug product to market quickly can be complex. Drug developers must balance the urgency of getting effective treatments to patients with the need to ensure safety, efficacy and regulatory compliance. Rushing through the development process can increase the risk of potential safety issues, and insufficient testing or validation can lead to subpar products that do not deliver the desired therapeutic benefits.
Rapidly scaling up production and distribution to meet increased demand can also strain the supply chain, with shortages in materials and manufacturing issues impacting the availability of the drug.
Strategies to Consider for Accelerated Timelines
To reach milestones quickly and overcome potential challenges, drug developers in DP manufacturing should consider several strategies. The strategies to streamline manufacturing speed include:
● Establishing a Robust Supply Chain
With more outsourcing, new modalities and high demand for therapeutics, it is essential to establish a strong supply chain. Reliable access to materials during drug development and manufacturing can minimise delays that can be caused by long lead times.
● Maintaining Efficient Technology (Tech) Transfer
Companies can benefit from a streamlined tech transfer process that ensures seamless communication through every stage of a drug development project. Timely tech transfer supports commercial-scale quality and the production goals of the project. Implementing tech transfer strategies will expedite therapy production and improve patient outcomes.
● Reducing Risks During Production
By identifying time constraints and process limitations that could lead to delays further down the development pipeline, areas can be identified that may need additional attention to detail. This allows for a mitigation plan to be put into place to preempt possible manufacturing challenges and allow for a solution to be implemented to then accelerate the path to commercialisation.
● Meeting Changing Regulatory Requirements and Guidelines
A strict quality management system (QMS) should be implemented throughout manufacture so that every raw material, component of drug production and manufacturing process is well characterised and defined to meet all good manufacturing practice (GMP) regulations. Integration of QMS will ensure the quality, safety and efficacy of all therapeutics reaching commercialisation.
● Ensuring Efficient and Timely Batch Release
Once a commercial batch has been manufactured, it should be released within the defined time frame of 30 days. Quality control (QC) testing should take place to confirm that GMP guidelines have been followed. At this point, information spanning all processes, procedures, drug formulation and equipment details should be collated and filed, so a batch can be released immediately. Continuous process verification (CPV) should be conducted for each commercial batch. The critical quality attributes should also be monitored throughout to ensure the commercial production process remains in compliance with regulatory guidelines.
● Maintaining Flexibility
Having flexibility through the conditional release of a therapeutic during commercialisation allows for DS batch release and DP manufacture to run in parallel. This can help balance the demand for critical treatments with patient safety. In addition, this can highlight the competitive advantage of end-to-end batch manufacturing.
● Encouraging Open Communication
Effective communication between the biologics developer and contract development and manufacturing organisation (CDMO) should be maintained from the beginning of the delivery process. Working together as a single unit allows for production goal alignment and incorporates originator client and CDMO expertise into technical and strategic planning workflows. This does not just maintain expectations of both entities throughout, but positions the project for success.
Engaging with an Experienced CDMO
Developing a DP is complex and comes with scientific, technical and regulatory challenges that can slow the progress to market. Therefore, companies are increasingly outsourcing activities to CDMOs to overcome development and manufacturing challenges, such as:
● The need to scale up biologics production.
● Maintaining product quality through to commercialisation.
● The requirement for specialised equipment and expertise.
The CDMO outsourcing market is predicted to increase by $287 billion between 2023 and 2030, at a compound annual growth rate of 9.2%. With demand in the market for therapeutics increasing, it is becoming more and more advantageous for manufacturers to align with an experienced CDMO from the beginning of development.
Engaging with a CDMO early in the drug development process ensures that goals are clearly defined so that the needs and outcomes of the project are considered when establishing a timeline. Embedding strict milestones into the timeline will ensure streamlined production with continued project momentum.
Forming a supportive and communicative partnership with a CDMO can propel the manufacture of biologics. Access to expert knowledge and specialised equipment can be gained through collaboration with a CDMO with experience driving therapeutics to commercialisation. In addition, it is essential to align with a CDMO that is at the forefront of developments in the biologics space, such as automated manufacturing and AI systems that are streamlining processes and data analysis, providing real-time insights that can further accelerate life-saving therapies to market.