Choose A CDMO Partner That Integrates Market Intelligence For Aseptic Fill And Finish

During drug development, converting an unformulated active substance into a safe and high-quality final product requires several technical decisions, including primary container selection (a complex and multifaceted decision in and of itself), choice of excipients, and more. Implementing precisely tailored, service-optimized aseptic fill/finish processes, specifically, is crucial for mitigating risks and achieving desired product outcomes. 

Today, a plethora of contract development and manufacturing organizations (CDMOs) provide aseptic fill/finish services around the world. However, to offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering.

The Importance of Market Intelligence

The remarkable digital infrastructure available today lets us gather and analyze market data points both deep and wide. In the right hands, quality intelligence yields quality insights, and quality insights are crucial for staying ahead of the proverbial game. A dynamic, real-time analysis of market trends helps define expectations, proactively mitigate identified risks, and drive confident decision-making during budget forecasting and production planning while materializing long-term strategic expansion plans.

To that end, a world-class CDMO takes time to cultivate deep knowledge of your chosen suppliers, competitive landscape, and scientific context. Drawing information from market fundamentals, novel research, funding announcements, and more, your partner should be able to recommend suppliers (paying careful attention to a supplier’s brand history and financial status), product attributes, and timelines that meet business and regulatory targets.

Other important variables affecting fill/finish operations, specifically, include:

• API and Raw Material Pricing: Indexing cost fluctuations for API/BDS (bulk drug substance) and other raw materials is important to make informed decisions that positively impact your cost of goods sold (COGS) and overall profitability. An effective CDMO will track this information and factor in global commodity prices to anticipate and address high-impact cost variables.
• Supply Market Economies: Economic conditions affecting your suppliers also play a large role in determining your COGS. Proactively monitoring these trends helps you choose suppliers that offer an ideal mix of cost, quality, and expected price stability. A forward-thinking CDMO will have the skillsets and relationships required to drive true predictive insights.
• Geopolitical Climate: Major policy changes can have a dramatic impact on your ability to source materials, achieve regulatory clearance, control price, or commercialize a product at all. Tracking geopolitical trends helps you marshal resources and make informed strategic decisions when doing business around the globe. An experienced CDMO will also provide highly specific strategic roadmap based on foreign governments’ existing and anticipated policies, behaviors, and regulatory expectations.

A firm grasp of real-time market intelligence is also critical for ensuring your chosen CDMO is adaptive and agile. Extraordinary events – such as natural disasters or a global pandemic – can devastate supply chains and supply economies, creating unexpected material and cost constraints. Accordingly, a firm that identifies (and prepares for) future risks is better positioned to weather unforeseen storms and protect your business during chaotic times.

Adapting Market Intelligence to Your Needs

Once your CDMO partner has curated the intelligence required to make informed decisions, they must be able to utilize that intelligence to meet your specific needs and add value. Providing a general report is not sufficient: all intelligence must be analyzed, compartmentalized, and presented in a manner aligned to your unique needs and goals. The right methodology can help you improve supplier quality, mitigate compliance and regulatory risks earlier and more cost-effectively, and importantly, expand or scale operations proactively, instead of reactively.

Integrated aseptic fill/finish market intelligence should position your CDMO to ensure:

• Proactivity: Your CDMO should be ready and willing to expand its manufacturing capabilities and capacities based on predictive insights. This could include expanding drug product offerings up (i.e., product capacity) or out (i.e., product capability).
• Flexibility: No two projects are the same. Accordingly, your CDMO should be flexible and accommodating for any product type or batch size. Small-batch aseptic products, for instance, not only present new sterilization, handling, and filling challenges, they also require reduced time-to-market.
• Comprehensive Expertise: Your chosen CDMO should be able to provide robust expertise based on successful, real-world experience. This range of expertise should include technical expertise (factoring in quality, MSAT, regulatory support, batch release planning, etc.), equipment expertise (leveraging and maintaining superior manufacturing equipment), expertise in personnel management, and expertise in supply chain management.

A thoughtful CDMO will focus not only the parameters directly affecting production but incorporate a wider view covering all channels associated with bringing a product to market, including regulatory and marketing. Look for a CDMO that has specific teams dedicated to these channels and incorporates a multi-dimensional view in every aspect of project planning.

Intelligence as a Catalyst for Innovation

Ultimately, a truly effective CDMO partner should be equipped to turn market intelligence into actionable, valuable innovation. Your partner should leverage advances in digitization, integrated IT, automation, and environmental conditioning to positively transform your aseptic fill/finish operations and deliver excellent value over the course of the product lifecycle. 

In today’s volatile and increasingly competitive market, innovative, differentiated production cycles can mean the difference between success and failure. Investors, payers, and patients expect products that live at the intersection of high value and sensible cost, and strategic, intelligence-driven production is fundamental to meeting these expectations.

Accordingly, at Samsung Biologics, we believe that a differentiated, strategic approach to product development, production, approval, and distribution is the rule, not the exception. Samsung has worked with small virtual companies with a single product and large international companies with deep pipelines. Each molecule brings unique characteristics and complexities, which is why we develop strategies and processes from the ground up instead of relying on overly general, standardized processes.

Case Study

Recently, a client approached us requesting the technology transfer of a unique commercialized product as part of an outsourcing practice. Key objectives included:

1. Adding redundancy to the client’s supply chain to improve resiliency & stability.
2. Improving certain process elements to enhance long-term product and production characteristics.

After listening to their needs, cultivating market intelligence, and entering collaborative discussions for the better part of a year, we agreed to help, anticipating complex technical needs and regulatory challenges. Beyond a “normal” tech transfer scope of work, the product/process would require:

• Developing out and remodeling a substantial portion of our manufacturing floor.

• Purchasing and validating a $1M+ piece of equipment crucial to the client’s process optimization.
• Purchasing, validating, and scoping long-term use of new premium-grade aseptic filling equipment dedicated specifically to this client’s product.
• Implementing a new container closure type for our site.
• Modifying software and hardware for two existing lyophilizer units, accommodating a processing cycle unique to the client’s product.
• Adapting our health, environmental and safety protocols specifically to the client’s process and product.
• Assisting in design and implementation of unique filtration systems.
• Providing a specialized visual inspection process tailored to the product’s unique characteristics.

Once the business agreements were in place, equipment and components were purchased early and work began on the technology transfer. Based on the established parameters, our experienced technical personnel – equipped with significant market and product– knew this was going to be a challenge from kickoff to regulatory approval.

The project proceeded on pace until a significant technical roadblock halted work just months before regulatory filing was planned. Through a robust series of investigations and experiments, we determined that the manufacturing process had to be fundamentally redesigned, eliminating the need for the scoped $1M+ piece of equipment – which Samsung had purchased specifically to service this project – from the process entirely. All of this came to a head while ensuring a hectic routine production schedule for other clients was not impacted.

Fortunately, Samsung subject matter experts (SMEs) were able to offer this client several viable ways to proceed, largely because of integrated market intelligence. By contextualizing the competitive field, leveraging experiential knowledge of similar products, offering multiple aseptic process options, and understanding the product’s specific regulatory environment, we positioned our client for future regulatory success while saving costs and minimizing disruption.

Preparing for an Uncertain Future

“Intelligence is the ability to adapt to change.” ~ Stephen Hawking

Ultimately, a worthwhile CDMO will do more than simply collect market intelligence: they will contextualize, integrate, and fully leverage it to better safeguard your business in uncertain times. If you are scoping a fill/finish project, partner with a CDMO that acts as both a strategic partner and problem solver. Samsung Biologics has the aseptic fill/finish experience required to meet and exceed almost any client expectation, and we are proud of our proven ability to problem solve in the face of complex and meaningful challenges.

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated contract service provider offering development, manufacturing, and testing services, all from a single location. We provide highly tailored solutions to clients, while meeting the evolving needs of the global healthcare industry.

With proven regulatory approvals, Samsung Biologics is a trusted CDMO partner of choice, and is uniquely able to provide seamless offerings from cell line development to final fill/finish as well as laboratory testing services at every stage for biopharmaceutical products.

To maximize our operational efficiency and expand capabilities in response to growing biomanufacturing demands, Samsung Biologics is constructing a fourth plant, which will further advance the company’s standing as the world’s largest manufacturing facility at a single site—holding a 604KL total capacity upon completion. Our facilities are all cGMP compliant with bioreactors ranging from small to large scales. We continue to upgrade our capabilities to accommodate our clients by investing in single-use technology and additional aseptic filling capacity. To further expand our global presence, Samsung Biologics will also open a new R&D Center in South San Francisco, which will be operational starting in October 2020. We are committed to an on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions, operational excellence, and proven expertise.