The process of biological product manufacturing (BPM) is a series of tightly connected operations which aims to efficiently deliver therapeutic products by utilising recombinant DNA technology, other forms of genetic alteration or developing a new compound or substance. The end product can vary from a virus to a vaccine, but has to meet the set aim of therapeutic application. The companies involved in BPM use multidisciplinary approaches including wet lab R&D, data analysis and scale-up strategies to create an end-to-end pipeline and maintain the quality of the biological product. Strong pipeline management methods are required to ensure that the biological product manufacturing process strictly follows Good Manufacturing Practice (GMP) guidelines. To help companies with the multidisciplinary nature of the BPM process, we have compiled a list of 6 management tips for the end-to-end production pipeline.
1. Managing of consumables and reagents stock
An important factor for maintaining a healthy and error-free pipeline in the manufacturing process is managing the consumables that have been utilised or are planned to be utilised. First and foremost, to ensure you will not run out of the necessary materials to keep your pipeline moving. Running out of materials upstream in your process can mean delays in developing and delivering your products downstream. Lab management software like Labstep can help you with keeping full track of your consumables and reagents. This is important not only for keeping a good record of your inventory, but also to ensure that any inconsistencies which have occurred with the manufacturing process in the past are fully traced and investigated - a crucial element in the maintenance of the whole BPM process and ensuring a smooth transition throughout the process, adhering to the GMP.
2. Linking parent and process-derived daughter materials
Keeping a tight link between your ‘raw’ materials and the products you derived from those through processing is imperative in your manufacturing pipeline. As with reagents, recording these links comes in useful when you need to trace back errors, but also successes in your final products. In your inventory management or product pipeline, make sure your software system allows you to establish these links clearly and allows you to maintain a hierarchical overview of the relationship between your raw materials, semi-processed products and final products. Such data management features are essential for GMP and ultimately deliver effective R&D measures for your company.
3. Establishing process and team responsibility along the pipeline
Ensuring that your team is aware of the full manufacturing process, but knows specific respective responsibilities is crucial for establishing a healthy manufacturing pipeline. A good approach to achieving this is to first, openly and explicitly discuss responsibilities and expectations for each team member. To facilitate efficient collaboration and responsibility hand-over between team members, a single connected research environment that reflects your team setup is a must. A single software to manage your pipeline processes and inventory and data avoids confusion, reduces admin time and unifies your team workflow. Additionally, it enables easy data management, efficient communication and can also help with security and access control.
4. Tracking incoming client requests
Rapid responsiveness to incoming client requests is crucial during the stages of building up your manufacturing pipeline. Having a reputation of a slow-to respond manufacturer may be detrimental for your sales, incentivising your clients to switch to other manufacturers in a highly competitive BPM market. It is also important to ensure that you have an expansive capacity to accommodate a growing number of client requests aiming to scale up their production with your help. Using a unified software that records incoming client requests and instantly activates the necessary successive processes can facilitate a rapid response from your team and also enables you to scale effortlessly. A unified software will also ensure that your researchers working on the different stages in your pipeline are always up to date on demand and are on the same page in terms of prioritisation and collective team effort.
5. Setting up processes to be scalable
According to biological product manufacturing market segmentation statistics, hospitals, specialised clinics and government research institutes comprise the largest end-user segments in the industry. It is expected that working with large institutions like those represented in this segment will require a strong capacity for manufacturing process scalability. Setting up your manufacturing pipeline accounting for scalability considerations from the get-go is crucial for building a successful portfolio.
6. Quality control checks
Strictly following the GMP guidelines in the manufacturing business is one of the most important aspects that affects your pipeline from end to end. The GMP guidelines are largely concerned with the state of the manufacturing facility, the manufacturing process itself and other phases like the clinical trials of the BPM, as well as quality controls of its safety and purity. It is hence crucial to understand the full spectrum of regulatory requirements and implement your quality control checks into your workflow to ensure that the process cannot be undermined by regulatory interference. Incorporating this digitally, i.e. through managing inventory, machinery and devices and wet-lab environments in-software is an efficient way to never drop the ball on quality control.
Labstep is a provider of scientific data management software for R&D organisations across industries (Biotech, Pharma, Biology, Chemicals, Agriculture etc) who need to manage, capture, share and use data effectively.
The Labstep platform is an end to end flexible research environment that connects your notebook, inventory, applications and data in one collaborative workspace.
To learn more about Labstep’s lab inventory management module, get in touch. Contact us or book a demo today.