The Evolving Biologics Development & Manufacturing Landscape

The Evolving Biologics Development & Manufacturing Landscape

The biotherapeutics sector has generated some of the greatest accomplishments of modern science and has developed highly effective therapeutics for a diverse assortment of diseases, including cardiovascular diseases, metabolic disorders, and wide-ranging rare diseases.

The industry has come an incredibly long way in a short period. For example, in the last five years, the number of facilities in the United States involved in biopharmaceutical production has grown by more than 55%. Also, the global market is expected to reach USD 853 billion by 2030, growing at a compounded annual growth rate (CAGR) of 11.3% from 2022 to 2030.

Along with the rapid revenue and manufacturing capacity growth within the sector, several factors are shaping the future of the biopharmaceutical manufacturing landscape, including trends impacting biologics contract development and manufacturing organizations (CDMOs).

Some of the most prevalent biopharmaceutical manufacturing trends include digitization, the rise of biosimilars, and process innovations to reduce costs and create operational flexibility.

Interestingly, many of the same trends facilitating competitiveness among the more established portions of the market also support the rapidly growing number of novel assets entering the pipeline from emerging biopharma market players.

The Impact of Digitization on Biopharmaceutical Manufacturing 

Over the past few years, the biopharmaceutical industry has experienced a disruptive shift in its established ways of working. Advancements in digital and analytical technologies have enabled companies to deliver new drugs faster, expand manufacturing capacities more quickly, and revamp collaborations with suppliers and CDMOs to accelerate drug delivery. Additionally, hybrid working models have been instituted to manage plant operations despite staffing shortages.

Embracing digitization in biopharma manufacturing can improve quality, speed, agility, and resilience, benefiting drug sponsors and patients.

By adopting digital and analytical tools at scale, innovative biopharmaceutical companies are implementing initiatives delivering value, such as:

Highly Efficient Planning

Digital twins and real-time virtual versions processes can enable biopharma companies to balance short- and long-term demand with the supply of raw materials, equipment capacity, and human assets, leading to improved scheduling of production and lab activities.

Reimagined Large Molecule Manufacturing

Highly innovative biologics manufacturing facilities are experimenting with advanced automation and production technologies coupled with augmented- and assisted-reality tools to facilitate such efficiencies as parametric product releases. These strides would enable significant gains in large molecule manufacturing productivity for human operators and could contribute to lowering the costs of goods.

Deviations Management

Advanced analytics models are helping plant leaders predict and mitigate quality risks, ensuring compliance and maximizing product robustness.

Paperless Biopharmaceutical Operations

Electronic documentation allows information to seamlessly flow from raw-material supply to planning, production, quality, warehousing, and distribution—often spanning internal and third-party supply and partner networks.

Proactive Risk Management

Predictive analytics enable real-time monitoring and management of maintenance, environmental, quality, and other supply-chain risks to maximize throughput, cost, compliance, and sustainability.

Remote Performance Monitoring

Interconnected systems allow real-time tracking of site performance, product status, and issue detection, resulting in more effective decision-making by management.

Due to the high costs of adjusting validated processes, the biopharmaceutical industry has been slower to digitize operations than other manufacturing sectors. However, many manufacturers are pressured to reduce costs and increase efficiencies and are therefore turning to digital technologies. New manufacturers have the distinct advantage of implementing digitization from the outset instead of overhauling legacy systems.

Expanding Biosimilars Market Is Driving the Need for Biopharmaceutical Development and Manufacturing Efficiency

 Arguably, the growing biosimilars market is one of the most significant trends accelerating the need for development and manufacturing efficiency. As of April 2022, there were approximately 200 biosimilars approved globally, and the market is projected to reach USD 44.7 billion by 2026, growing at a CAGR of 23.5% between 2021 and 2026. Factors like patent expirations for blockbuster biologics, advancements in analytical and characterization technologies, and legislative and regulatory support are driving this growth.

 Although slowed by disruptions within manufacturer organizations and the FDA during the COVID-19 pandemic, the biosimilars market rebounded in 2022, and the agency approved six products, while there were only seven approvals in the previous two years. The most meaningful movement in the market is minimally seven biosimilars referencing AbbVie’s blockbuster Humira (adalimumab), the highest revenue-generating therapeutic in history, poised to launch in 2023.

 Since biosimilars are more complex to develop and manufacture than small-molecule generics, the specific economies of the biosimilar sector are still being determined. However, cost pressures within the healthcare system and recent 2022 legislation permitting multiple biosimilars for any given reference product make it clear that the biopharmaceutical market will face increasing cost pressures requiring greater manufacturing and development efficiencies.

The Promise of Continuous Biologics Manufacturing

 As the biopharmaceutical industry matures and cost pressures from the biosimilars segment manifest, the need for more efficient, cost-effective, and robust manufacturing processes has become evident. Continuous or partially continuous manufacturing could be a meaningful opportunity to generate the operational efficiency needed by therapeutics new to the market and established therapeutics facing biosimilar competition.

 As of 2022, the FDA approved only 13 drugs manufactured using continuous manufacturing processes. But, significant efforts and investments are being applied to advance these approaches.

 Continuous manufacturing uptake is challenged by the tremendous expense of changing validated and approved production processes, the reality that some cell types are not amenable to continuous processes, and the prevalence of fed-batch bioreactors.

 Fed-batch bioreactors culture cells until cells eventually consume all the nutrients, overwhelm the media with waste products, and do not fit into continuous processes well. Conversely, perfusion bioreactors can support cells for months by continuously feeding them fresh nutrients, removing spent media, and harvesting products, and are well-suited to continuous biopharmaceutical manufacturing processes. However, this technology lost favor numerous years ago because it is typically more challenging to scale and operate.

 Additionally, work is being done to advance continuous separation technologies and continuous or partially continuous downstream processes. While the adoption of continuous or partially continuous processes is in its infancy, increasing cost-reduction pressures are causing the industry to look at its adoption more carefully.

Single-Use Systems Help Biologics CDMOs Reduce Costs

Single-use systems (SUS) have been on the market for some time and have been widely adopted. A drastic reduction in cross-contamination risks is the number one advantage of SUS, and scaling production is much easier because SUS are highly flexible and avoid the need for significant capital equipment investments.

SUS also offer the opportunity for significant operational cost savings.

It can take weeks to change over production lines for facilities using traditional, fixed equipment. Complex clean-in-place (CIP) and sterilization-in-place (SIP) protocols are time-consuming, labor-intensive, and expensive to execute. With single-use systems, like those used by Scorpius BioManufacturing, the changeover time can be reduced to days and is essential to competing in today's market.

Additionally, SUS contribute to sustainability objectives as a conventional biopharmaceutical facility requires large amounts of energy to heat the steel equipment to operating temperatures and consumes large amounts of resources like pressurized air and water. Single-use assemblies are recycled and have been shown to lower costs and a facility's carbon footprint.

Scorpius BioManufacturing Supports Process and Modality Innovations

Many biopharmaceutical development and manufacturing market trends are those classically faced by maturing markets where innovation is often focused on improving processes to compete within an increasingly competitive market.

Interestingly, the biopharmaceutical market is simultaneously managing classic cost pressure considerations of a more developed market while innovating process technology to address the multitude of complex and novel products in the pipeline. The Scorpius development and manufacturing teams carefully consider movements in the industry, like continuous manufacturing and the growth of the biosimilars market, to determine how to best respond to the industry’s current and future needs.

Regardless of where clients are within their product's innovation lifecycle, Scorpius BioManufacturing services focus on accelerating their product’s journey to market. By integrating analytical methods development, process development, cGMP manufacturing product characterization, and QC release testing, Scorpius can efficiently develop a client-specific clinical manufacturing solution that enables a faster path to commercialization.