In recent years the healthcare landscape has evolved at a significant pace, particularly regarding the development of complex drugs and new therapeutic approaches and modalities requiring advances in manufacturing technology. With concomitant political and economic factors impacting the integrated global supply chain, we have a set of shifting circumstances that are continually challenging biopharma innovators and developers.
The number of FDA new drug approvals in 2022 was 37, which included 22 small molecule and 15 biologic drugs. Oncology was the lead therapeutic area with 11 approvals, followed by autoimmune therapies with 7 approvals. 23 of the 37 FDA-approved drugs in 2022 were considered first-in-class therapies. Additionally, there is an encouraging number of new targeted medicines being developed based on the principles of personalised medicines. The knock-on effect of this for all stakeholders in the drug development space, from contract researchers to contract manufacturing organisations (CMOs), is better access to innovative solutions enabled by technology and newly developed expertise.
It is anticipated that these technologies and expertise will create opportunities for greater flexibility in drug development, translating into efficiencies across functions for CMOs. Adapting timelines and workflows are examples of how to incorporate flexibility into processes. In collaboration with clients, efficiency gains can be optimised.
Quantifying flexibility as CMO characteristics
There are multiple examples where Symbiosis leverages collaborative and operational flexibility that helps to differentiate the company. This could be flexibility in manufacturing slot scheduling, exemplified by being able to bring forward or delay manufacture at relatively short notice with only minimal impact. Our clients tell us that they value highly our responsiveness and flexibility.
Flexibility can be realised when it comes to the manufacturing process. Where the industry is governed by the regulatory framework, there remains some opportunity to be flexible in terms of manufacturing solutions which can help support development challenges a client may face. Small agile CMOs like Symbiosis can offer a greater level of value-adding flexibility, particularly in the early stages of drug development.
The mutual benefits of flexibility are demonstrated by a client that had a drug substance requiring specific containment for manufacture of drug product. The Symbiosis team worked to assess the product and its manufacturing process and were able to implement appropriate processes to enable safe and efficient manufacture. The client benefitted from a process that was suitable for the follow-on development candidate in its pipeline.
A flexible approach can enable the start of the manufacturing process in good time and avoid protracted technical difficulties upfront. Changes to the project once initiated may lead to delays. A balance is required, and our expertise will enable efficiency gains throughout manufacturing.
Symbiosis has experience of clients needing to change their processes in the transition from clinical trial batch to commercial manufacturing. When required, we will work with clients to redesign the manufacturing process to achieve commercialisation objectives, whilst engineering the design to optimise efficiency. In our experience, this flexibility creates lasting relationships that are built on trust.
Similarly, across the complex emerging modalities (e.g, ADCs, ATMPs), Symbiosis has a series of optimised processes that leverage our experience to gain process efficiencies. However, we will consider the potential impact of factors such as the introduction of new equipment, new reagents and new in-process measurement methods to determine a suitable protocol for development, with consideration for commercial release later on in the lifecycle, that will deliver long-term gains for our clients.
Flexibility in support levels
Due to our position in the market and the typical client profile, we support a wide range of clients regarding size and experience and this is when we deliver additional value by leveraging our experience.
We can provide advice and guidance on aspects that drug developers might have uncertainty about, such as how to approach certain types of manufacturing platform. Additionally, we can support with insight into the technologies that can enable scale-up scenarios or allay concerns about how to implement guidelines and regulations. We know that our clients appreciate our specialist expertise that adds value to both the project and their drug product. Delivering important aspects of quality, experience and a fitting service portfolio, as well as having a client and patient-centred attitude, is where we can deliver additional value for developers.
Flexibility in approach
It is common that our clients have an urgent requirement for fast access to timeslots. Following discussions with such clients and understanding their needs, we can amend our manufacturing schedule to be flexible, whilst maintaining our commitments to all other clients.
We have been able to offer start times within 2 weeks and achieved this by being flexible with the schedule. The wider Symbiosis team – Technical, PM, QC and QA – effected communications to enable our team to understand the Client’s process, discuss technical/information requirements, ensuring an open and collaborative approach, all working towards the same goal.
Flexibility as a core value proposition
Symbiosis has a set of value propositions that very clearly define our service offering, philosophy and commitment to serving our clients. We feel it is these that help set our overall agenda and allow for consistent delivery of service that we know our clients value. It is these factors that set us apart and go beyond the usual considerations of cost and availability that harness the relationship making it a collaborative partnership. This is the value of Symbiosis.
To find out more about our flexible approach, contact us today