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Protecting the Supply Chain: What Immunodiagnostic Companies Need to Know

Diagnostic companies invest substantially in developing new products. Many think their biggest challenge will be developing the perfect test, but optimizing their new product supply chain to be secure and efficient is nearly as important and difficult as creating their product. The best diagnostic will fail in the market if the company can’t meet production timelines and costs.

During and post-development, immunodiagnostic companies find themselves in a few specific binds:

  • In-house manufacturing can’t keep up with product portfolio expansion.
  • Antibody manufacturing can be inherently unpredictable.
  • It is challenging to assess the reliability of a potential outsourcing supplier against price point.

In this article, we’ll take a look at how these issues impact product launch and revenue, and present some suggestions for overcoming these roadblocks.

In-house manufacturing: how much trouble is it worth?

Speed to market can heavily influence a new product’s success. Even when there are no pressing competitors, any delay lengthens the runway to seeing a return on investment (ROI). In-house manufacturing can decrease the cost of manufacturing each product (after the initial capital expenditure) and could help get products out the door faster and on a company’s own schedule.

In-house manufacturing comes with significant challenges.

As a company’s product portfolio grows, their own manufacturing facility begins to lose its supply chain advantages. Companies with in-house facilities designed around roller bottles, ascites, or a single product at a time eventually reach their capacity. Products are delayed not due to issues in development or design, but because in-house facilities are already booked out with current products.

Changes in production strategy between products or in the manufacturing process also affects how much and how quickly each batch of antibody can be made. In an overburdened production facility, flexibility is a commodity.

Organizations with insufficient in-house production face two choices:

  1. Build out their internal capacity to meet their growing portfolio needs
  2. Outsource to a contract manufacturing organization (CMO)

Impact of Investment

As the product pipeline grows, companies reliant on in-house manufacturing may consider building out additional capacity. To make this decision, they must carefully weigh the benefits of additional manufacturing space against the risk of the investment.

While “adding more capacity” sounds like an easy fix, new facilities cost millions of dollars to construct and maintain. In a volatile industry, this is an enormous risk. Product demand is difficult to forecast, and redundant capacity can be an expensive mistake.

Redundant in-house capacity can be an expensive mistake.

Building out a new facility – especially a GMP facility – can take years.  For that reason, companies need to invest well before they have a product to launch. Therefore, they need to be certain that a build-out will have the appropriate ROI before deciding it is the right option for them.

Turning to a CMO

The alternative option is to employ a contract manufacturing organization (CMO). These entities offer services to simplify the production process to save diagnostic companies time and money.

CMOs provide flexibility via their own manufacturing facilities. A good CMO will have the ability to scale-up or -down according to the product’s market demand without putting strain on prices or timelines.

This is especially true for CMOs with modular, closed-loop biomanufacturing systems such as hollow fiber bioreactors. This in vitro method of production takes up very little space and can be wheeled in and out of facilities as needed. This added level of adaptability allows CMOs to reduce overhead costs and pass those saving on to the customer.

A CMO also brings expertise and quality, both of which are difficult and expensive to obtain and manage. For companies with fledgling products, bringing in a CMO who can optimize a production process to decrease manufacturing cost of goods is a worthwhile investment.

C3 as your manufacturing partner

Cell Culture Company’s mAbVault program may be the supply chain answer your company is looking for. Over the past thirty years, we have produced low cost, high quality biologics for some of the largest diagnostic companies in the world. Our supply chain solutions offer:

  • Guaranteed price per mg of product
  • Guaranteed quantities and long-term storage
  • Lower investment, cost, and flexible pricing options
  • Pay only when we ship product to you

For more information on mAbVault or to discuss supply chain options with us, please visit our website at https://cellculturecompany.com/supply-chain.

Post by Samantha Dunmire, PhD and Emily Wozniak, PhD

Ditch the Mouse: How to Tackle Your Ascites Problem

Despite decades of advancements in in vitro antibody production methods, many of the world’s largest diagnostics and reagents companies are still manufacturing in mice. The ascites method of manufacturing is inherently problematic due to batch inconsistency, supply chain unreliability, quality issues, and the ethics of using animals when alternatives are available.

In this post, we’ll walk through the history of ascites manufacturing, why more and more companies are moving away from ascites, and how it can be effectively accomplished while minimizing risk to the product.

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The Perfusion Revolution

Article contributed by Brittni Peterson, PhD, and Emily Wozniak, PhD
Adopting new technologies is a challenge in heavily regulated environments, as innovation is often stymied in favor of safer, established technologies. This is especially true of the biomanufacturing industry. Mainstream bioreactors have been improved only incrementally since the original fermenters that produced ingredients like citric acid in the 1920s (Pictured, left) or yeast in the 1930s and 40s (de Becze and Leibmann, 1944).
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Finding your fit: Small-scale CDMOs

Article Contributed by Brittni Peterson, PhD and Emily Wozniak, PhD

Large-scale therapeutic products (many kg’s per year) command respect from contract manufacturers. These products generally consume dedicated manufacturing suites for multiple years and guarantee premium budgets. Their owners are often large pharmaceutical companies with significant resources and a track record of paying for the best.

Most Contract Development and Manufacturing Organizations (CDMOs) cater to these products because they are manufactured at a high price tag and come with guaranteed capacity utilization.

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