Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Making The Switch: Continuous Manufacturing vs. Batch Processing of Pharmaceuticals

THE XTALKS BLOG

Pharmaceutical Manufacturing

In contrast to batch processing, continuous manufacturing sends raw materials through an uninterrupted, nonstop process until the final product is completed.

Share this!

May 5, 2016 | by Sarah Massey, M.Sc.

Pharmaceutical manufacturing hasn’t changed much in the last 50 years. While it’s true that some advancements have been made in terms of the technology used to create drugs, the underlying processes are still largely the same. Most drugmakers are still relying upon batch processing, in which a pharmaceutical product is made through a step-wise process.

While reliable, batch processing can be a slow way to manufacture drugs. The more time partially-completed products spend between steps, the higher the risk of potential contamination or human error.

Between 2004 and 2015, the total number of drug recalls grew by over 1,200 percent. While it’s true that the number of newly-approved drugs has been growing at a rapid rate every year, this doesn’t fully account for the increase in drug recalls. As many of the issues with contamination occur during the manufacturing process, it’s important that drugmakers implement the best possible production process to limit the risk of recalls and protect consumer safety.

It’s estimated that the pharmaceutical manufacturing industry wastes up to $50 billion per year on inefficient processes. Various raw materials – including the active pharmaceutical ingredient (API) – are produced at separate facilities around the world, adding to the overall inefficiency of batch manufacturing.

Continuous Manufacturing

In contrast to batch processing, continuous manufacturing sends raw materials through an uninterrupted, nonstop process until the final product is completed. This approach is a faster manufacturing method; the US Food and Drug Administration (FDA) estimates that some drugs which normally take a month to produce using conventional batch processing, may only take one day to make using a continuous manufacturing setup.

Continuous manufacturing – which is the standard method in a number of other sectors, including the automotive, food and electronics industries – is currently used to produce primarily over-the-counter, largely non-pharmaceutical products, such as personal care items. While the technology could be applied to pharmaceutical production, the industry has been slow to adopt continuous processing due in part to its high startup costs.

Along with being a faster, more efficient way to manufacture pharmaceuticals, continuous processing could also be safer compared to batch methods. By eliminating steps involving human intervention, the risk of error could be substantially decreased.

Continuous manufacturing methods also allow quality control to be built directly into the process of drug production. In the case of an identified quality issue, specific quantities of a drug produced via a continuous workflow can still be tracked and identified by a unique lot number.

In addition, once the initial investment into continuous manufacturing equipment, processes and training is recouped, the technique could be an overall cheaper way to produce over-the-counter and prescription drugs. Compared to batch processes, drugmakers who implement a continuous manufacturing method could save between 40 and 50 percent in variable costs, according to the National Science and Technology Council.

These reductions in manufacturing costs could be passed along to consumers in the form of more affordable pharmaceuticals. The continuous processing method could also help prevent drug shortages of vital medications by reducing the lead of time of a given product.



Early Adopters

The continuous drug manufacturing method has already been adopted by some key players in the pharmaceutical industry. Since its approval in July 2015, Vertex’s Orkambi – a drug used to treat patients with cystic fibrosis – has been manufactured using a continuous process.

Earlier this year, pharmaceutical giant Eli Lilly announced that they would be investing €35 million in a purpose-built continuous active pharmaceutical ingredient (API) production facility in Ireland, for products in the company’s late-stage pipeline. The FDA also recently approved the first manufacturing switch from batch to continuous processing of an approved drug. As of last month, Belgium-based drugmaker Janssen has been manufacturing their HIV-1, Prezista, using a continuous manufacturing method.

The FDA has officially endorsed continuous manufacturing in an articles posted on their FDA Voice blog. In addition, the agency has released draft guidance to help pharmaceutical manufacturers modernize their processes.

Despite the lack of regulatory hurdles preventing pharmaceutical companies from adopting a continuous process, there is a lack of experience with the manufacturing technique within the industry. The FDA recommends that drugmakers interested in switching from batch to continuous manufacturing methods have frequent discussions with the regulatory body to facilitate planning and eventual implementation.

As the pharmaceutical industry moves toward precision medicine – in which unique formulations will need to be produced more quickly – it’s unlikely that the traditional batch model will continue to be standard for drug manufacturing. By switching to a continuous process, drugmakers will have more control over their products and will be better able to adapt to changes in demand.



Keywords: Pharmaceutical Manufacturing, Drug Recalls, FDA


| NEXT ARTICLE | MORE BLOG POSTS | NEWS | VIDEOS | POLLS & QUIZZES | WEBINARS |

 

Share this with your colleagues!




READ THESE NEXT
Survey Results Say eConsent Adoption is on the Rise

April 12, 2017 - The State of eConsent 2017 Report released by CRF Health surveyed 100 biotech, pharmaceutical, CRO, and IRB organizations who shared their opinions on Electronic Informed Consent (eConsent) and its ability to produce greater levels of efficiency, effectiveness, and patient engagement in clinical trials.


Ask an Expert: 5 Questions About Regulatory Requirements for Combination Products

April 6, 2017 - The regulatory pathway and corresponding regulatory requirements for combination products can often be unclear and daunting for drug makers and medical device manufacturers.


Cold Chain Considerations for Cell Therapy Clinical Trials

March 30, 2017 - Among the most important components to a successful cell therapy clinical trial is the necessity of controlling the environmental conditions to which the biological product is exposed. To understand how sponsors can reduce risk and position their product well for commercialization, I sat down with Kristen Franklin, Client Services Manager, Cell Therapy and Amy Hendricks, Project Manager, both from Fisher BioServices.

LEAVE A COMMENT
 
  
THE XTALKS VITALS WEBINAR PRODUCTION TIPS BLOG

Top Ten Webinar Production Tips of 2016

REGISTER FOR THESE WEBINARS

Developing a Biological Safety Evaluation


Electronic Informed Consent: 2017 Industry Survey Results


Critical CRO Oversight Metrics: How to Establish the Right Metrics and Monitor them in Real-Time


The Modernization of eCOA Technology for Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.