Monoclonal Antibody Manufacturing in Biopharma Companies

A company’s strategy is crucial for determining future success, and therefore, it needs to constantly change in line with market dynamics.

Today, mAbs represent the dominant product class within biopharmaceuticals, driven largely by the increasing prevalence of – and increasingly sophisticated approaches to treating – severe and complex diseases, including cancers. Additionally, in 2020, 55% of biologics reached the clinical stage (628 of 1133), with 426 products related to mAbs. Accordingly, most development stage biologics today are mAbs or  mAb-related.

In recent years, the standardization of biologics manufacturing processes has given biopharmaceutical companies multiple viable options for producing mAbs, like do it in-house or partnering with a contract biologics manufacturer. Although building in-house does offer the advantage of direct control, the time, labor, and spend required to implement this often makes it the inefficient choice. By working with an innovative, strategic, and experienced CDMO you can make better use of valuable internal resources, leverage a deep pool of industry experience, and mitigate risk across development cycles, keeping you competitive in a rapidly evolving market.

The process of selecting the right CDMO partner needs to be performed after careful analysis of many factors: any of which, if overlooked, can create risk of delay or cost overrun. These factors are:

  • Speed to Market
  • Scale Up efficiency
  • Expert Partner

Now, let´s see them one by one

Critical factors that Biopharma Companies should consider when manufacturing mAbs

1. Speed to market

As the global biologics market continues to grow, speed has never been a greater priority.

Increased speed helps biopharmaceutical companies provide breakthrough therapies and give new hope to patients. The market tends to reward novelty, making first-to-market launches highly valuable. Additionally, it adds time pressure on long-term profitability, creating sharply defined peak revenue windows within market cycles.

That is why, an ideal contract manufacturing partner should prioritize both speed and due diligence immediately following project execution. The goal here is to reduce total development time while preserving or improving quality. A complete technology transfer should occur as quickly as possible, in a validated facility ready for immediate use.

Related Read: Accelerating Biologics Manufacturing

2. Scale Up Efficiency

No matter what stage of development your mAb molecule is in, you need to be able to produce or exceed your target yield at your desired scale. Underperforming here drives up your cost of goods, hurting profitability.

bioreactor

Equally important, however, is the ability to change scale of production at will. Many facilities are equipped to effectively manage production at one scale (such as early clinical, late clinical, and commercial), but not at others. This essentially guarantees significant time and productivity loss when unforeseen changes occur, creating notable risk.

Beyond speed, a quality manufacturing partner will be able to accommodate your mAb production at any developmental stage (such as cell line development, toxicology, phases 1-3, and commercial), saving you considerable investments in talent and technology.

If product needs change, a partner with a multiscale facility can pivot to meet your needs in little time, with all resources, supplies, and personnel already on-site.

Related Read: Upstream and Downstream Optimization in Biologics Manufacturing can Help Reduce Inefficiencies and Cost

3. Expert partner

Working with an expert contract manufacturing organization you forge a partnership that adds true value, both within your specific project context and for your organization.

our team

When unexpected challenges appear, efficient resolution requires problem discovery, robust strategy, and confident execution. By hiring a team of experienced specialists, a high-value partner will help you proactively flag issues hiding in plain sight, as well as resolve issues that emerge during production.

Additionally, your partner should be able to provide regulatory support for your submission, helping you navigate dossier creation, submission, and revision. By offering both manufacturing and regulatory support, the right partner creates unmistakable value, given the capital investments required to staff both operational areas.

Related Read: 4 Factors to Consider to select your CDMO Partner

Speed to market, efficiency at scale, and operational knowledge bases are critical factors developers must consider when deciding to manufacture mAbs through a contract manufacturer.

As an expert CDMO, 53Biologics offers its customers valuable technical and strategic capabilities that reduce time to market, improve efficiency, and solve costly problems along the way. We provide fully integrated end-to-end services –including cell line development, commercial manufacturing of drug substance and drug product, and biosafety testing services– all from a single site, delivering our customers value, consistency, and peace of mind.

If you are looking to develop or commercialize a mAb product in an increasingly competitive marketplace, we are here to help you meet and exceed your goals.

Talk to the mAb manufacturing experts at 53Biologics NOW!