Biotechnology companies have specific needs when it comes to the design and construction of their facilities. They need laboratories that are specifically designed for the handling of sensitive materials, as well as clean rooms and other spaces that meet stringent requirements for air quality and purity. This article will discuss some of the challenges involved in designing and constructing a facility for a biotechnology company.
Startup organizations generally lack the technical skills and resources to design and build their own lab facilities properly. This is typical among startup organizations formed around concepts, researchers, patents, and technologies. They are much more likely to be accustomed to lab-based development and cannot contemplate the scalability of mass production at facilities. These characteristics can carry over and impact the design and construction of a biotech facility.
Below are some of the reasons that lead to technical obstacles.
- Gap between what scientists think is necessary to develop a commercially viable process and the actual needs of businesses
- R&D is frequently drawn to more powerful and more extensive lab equipment, which isn’t always essential for scaling or efficiency during process development at facilities. End to End facilities deals with common processes involving lab centrifuges, manual handling, surfactant/solvent usage, and batch professing depending on where BSC is placed in relation to refrigerator and incubator
- Due to unfamiliarity with industrial systems and systems, inefficient, tedious, and lengthy processes cost inefficiencies exist
- Processes are viewed in the context of laboratory procedures that are usually inefficient, have little output, and are susceptible to contamination
- Quality Control, Quality Assurance, Biosafety, Industrial Safety, and Biosecurity are disregarded as they are seen as obstacles to progress.
- False sense of security based on small scale exposure in research labs and universities
Biotech startups face numerous manufacturing challenges. They must have facilities with equipment to design and validate their manufacturing processes and ensure that their products meet all regulatory requirements.
Lack of Necessary Facility Design
One of the major challenges is not having an adequate facility with technology and organization set up to bring products to Phase 1 and Phase 2 clinical trials. Biotech startups with this inadequacy cannot manufacture safe and efficacious products in a consistent and reproducible manner, according to GMPs. Having a facility with industry-compliant design must be a corporate goal.
Scalability While Maintaining Accuracy
Biotech companies must maintain Accuracy, precision, and consistency in order to achieve scalability. Keeping up with demand is tricky because of product yield, equipment variability, number of dosages, product presentation, and raw material variability. Plus, it’s important to consider how many clinics and patients will need the product at all phases, making it difficult to figure out how much and how big a facility should be.
Regulations governing the manufacture of biologics are constantly changing, and companies must be prepared to adapt their processes and facilities accordingly. All manufacturing process data must be reviewed to meet GMP regulatory requirements, including the 21 CFR Part 11 requirement for electronic records.
It is not easy to find and train employees who can work in a biotech facility. The company must have a plan in place to find and retain qualified employees. The company must also have a system in place to track employee training and certification and compliance with safety regulations. Another operational challenge is managing the inventory of raw materials and finished goods. The company must have a system to track all components in the manufacturing process, from start to finish.
The company also needs a plan for the disposition of products that don’t meet specifications or are recalled. The company must have a plan to ensure the security of its facility and data.
They must also have a system in place to track and report any adverse events that occur during manufacturing.
Biotech facilities are expensive to build and operate. Startups often don’t have the capital to invest in a state-of-the-art facility, so they must find creative ways to finance their operations.
The company must also have a plan for long-term financing of its facility.
Operating a biotech manufacturing facility is not cheap. Companies must have a plan for covering the costs of utilities, labor, raw materials, and equipment.
The company must also have a plan to recover the cost of building and equipping its facility.
It can be challenging to design and build a biotechnology manufacturing facility. Many factors need to be considered before beginning a project or process of this nature. That’s where it comes in handy to have a great project manager or engineering leader on hand who can help pinpoint the particular challenges of the project or process and develop a game plan to address these concerns. A planning checklist may include information on the following:
- The type of products to be manufactured
- The types of processes to be used
- Use of single-use systems (SUS)
- The regulatory environment and any specific requirements that must be met
- How the facility will meet GMP compliance
- An outline of the manufacturing process from start to finish, including all quality control measures
- The maximum and minimal upper and lower limits for process scale
- An estimate of Process time duration from receipt of materials to final form
- Investment funds available to get started (CQV)
- A plan for employee training and safety
- A system for tracking and managing inventory
- Security measures that will be put in place
- Month-to-month cash flow allowances (CFA)
- An adverse event reporting system
In conclusion, while there are many challenges that face biotech start-ups, a successful outcome is possible with careful planning and execution. By understanding the challenges ahead and developing a plan to address them, Managers can ensure that the biotech manufacturing facility is designed and constructed for success.
If you have any questions about setting up a biotech manufacturing facility, please let us know and we would be happy to help.