Bispecific antibodies, monoclonal antibodies (mAbs), and other biopharmaceutical drugs can be more potent and specified than small molecules because of their macromolecular architecture, which means they can be targeted more precisely thanks to their structural complexity.
But this structural complexity can also make the manufacturing process fairly challenging, and biotech firms need to be able to overcome these challenges to effectively bring their innovative therapies to the market.
This article will discuss the 5 biotech challenges and the solutions for overcoming them.
1. Production Parameters
Determining and achieving the optimal conditions for production processes is the first challenge that biotech firms will face. They’ll need to make the right choices based on purification methods and cell culture conditions which is made difficult due to the need to control factors like product quality, purity, and yield.
There’s unpredictability from the variability in raw materials and biological systems, which means effective control strategies need to be implemented to ensure batches are consistent and reproducible.
2. Scalability
Another element of biopharmaceutical production that can be challenging is transitioning from small-scale lab processes to larger-scale manufacturing.
This can present issues with efficiency and variability, and it’s important that biotech firms ensure their processes are scalable and reproducible to successfully scale up without bottlenecks.
3. Regulatory Compliance
In the early stages of drug development, meeting regulatory requirements can be a hurdle.
Pharma companies must ensure that their processes adhere to the guidelines established by regulatory authorities if they want to quickly advance to later stages of development without wasting resources.
4. Infrastructure
Establishing the infrastructure for process development presents its own challenges, and drug development companies will need to learn quickly as they integrate novel technologies and methodologies into the processes.
Many processes simply can’t operate without the necessary infrastructure, and that means investing in often expensive solutions to achieve the desired results.
5. Cost
Cost is the final challenge related to biotech production, and companies need to set realistic efficiency goals based on their budgetary limitations.
This involves making strategic decisions to thoughtfully allocate resources for achieving data milestones.
How to Resolve or Avoid These Challenges
The best way to resolve or even avoid these challenges is to utilize an optimized development (pre-GMP) package provided by a company like Wheeler Bio. These packages help to make the drug development process more efficient while ensuring high-quality standards are met.
Biotechs can use a pre-GMP process development package to streamline their pathway from the early phases of development right up to CGMP manufacturing, reducing the challenges associated with handling the research and production stages alone. This approach ultimately enables companies to confidently and efficiently advance toward commercialization.
Conclusion
There are numerous challenges to be faced along the journey from drug development to delivery, but there are companies in existence today that offer solutions to mitigate these obstacles and help you forge a smoother path to market.
Biotechs can take advantage of these company offerings to reduce costs and speed up their drug development processes, revolutionizing the drug development journey and maximizing their success.
