A Complete Guide to Biopharmaceutical Process Development & Manufacturing
A biopharmaceutical is a medicinal product extracted or manufactured using biological sources. Biologics are often referred to as products manufactured using recombinant DNA technology. Biosimilars, on the other hand, are drugs that have been approved. Biopharmaceutical manufacturing has changed drastically over the last few decades.
Major changes have been witnessed in single-use technology whose advantages include reduced resources for cleaning and cleaning validation, better flexibility, and faster turnaround between products and batches, resulting in increased speed to market and reduced capital costs.
Biopharmaceutical process development and manufacturing focuses on the development and the practices and process approaches in providing regulated and cost-effective manufacturing of biologics in a timely manner that fulfil their intended use. Good manufacturing practices ensure that manufacturers constantly produce drugs to fulfil the purity, strength, identity, and quality.
Here are some of the conditions that must be followed as part of good manufacturing practices:
- Competent and skilled personnel.
- Facilities should be appropriate for their planned purpose with appropriate plumbing, handling, lighting, and sanitation.
- Standard Operating Procedures (SOP) for validation, cleaning, testing, and manufacturing must be established and followed.
- Records to establish GMP compliance should be maintained properly.
Recipe for a Successful Biological Product
For a biopharmaceutical to be successful, there must be a need for the product, and it must be cost-effective and efficacious. On the other hand, from a manufacturer’s standpoint, a successful product is one with a strong process that can be mass-produced on a regular basis and fulfils regulatory specifications. The best ones are those that enhance patient lives.
A successful product fulfils patient requirements in a way that can be supported by local healthcare providers, with a supply chain that reliably supports demand while creating a return on investment to the product developer.
What Do Process Development Scientists Do?
Biopharmaceutical process development scientists have a major role in the manufacturing process Here’s a list of what they do:
- They scale up the production process through plant trials, by making changes to process parameters to ensure quality is maintained during large-scale production.
- Come up with new or improve prevailing processes to optimize the manufacturing process.
- Prepare technical reports and specifications.
- Implement process controls to ensure the products are of the highest quality and are manufactured in a reproducible manner.
- Improve profitability and efficiency of the process by lowering cost and employing new technology to enhance efficiency.
Anaytical Process Development
Cost-effective and efficient paths to candidate drugs are established during the drug development lifecycle. It comprises an examination of the influence of various parameters on product quality and process performance. Access to precise analytical information at the right time is essential to complete process development projects efficiently and effectively.
Consequently, different methods are evaluated frequently and optimized through different phases of the drug development lifecycle for product characterization.
With robust and well-designed analytical testing strategies, it is easy to confidently ensure product quality. This is a significant responsibility and represents a substantial amount of work that must be documented and communicated clearly to ensure effective and efficient review by regulatory authorities before product approval.
Investigative data on product quality and impurity are required to gain comprehensive process knowledge to determine additional parameters required to inspect and enhance the conditions for producing drugs on a commercial scale. Predictive models can be developed to enable technology transfer and scale-up.
So, both the appropriateness and timeliness of the data can affect the productivity of the drug development process.
Biopharmaceutical companies must establish an experienced analytical team that focuses on supporting Biopharmaceutical process development and ensure rapid tech transfer and scale-up of biopharma partner processes.
