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

• 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.

Analytical Process Development

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. 

Biopharmaceutical process development scientists have a major role in the manufacturing process Here’s a list of what they do:

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.