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Bringing new biologics to market is complex, with high failure rates. Learn how de-risking formulation and optimizing shelf life early can accelerate your drug product development. Discover strategies to overcome common challenges.
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1. Current Situation
2. Typical Market Trends
3. Current Challenges and How They Are Solved
4. How Leukocare Can Support These Challenges
5. Value Provided to Customers
6. FAQ
Paving the Way for New Therapies: A Look at Drug Product Development
The path to bringing a new drug to market is complex and filled with challenges. If you're leading Chemistry, Manufacturing, and Controls (CMC) or drug product development, you're under pressure to handle this landscape well. This article will explore the current state of drug development, common trends, and how to tackle the challenges that arise.
1. Current Situation
Developing a new drug is a lengthy and expensive process. It can take 10 to 15 years for a new drug to get approved [1]. Many promising candidates fail along the way, often due to issues with the drug's formulation. In fact, 95% of drugs that enter preclinical trials do not make it to a successful Phase III [2, 3]. Early planning and de-risking formulation are critical to improving these odds [2, 3].
Small and emerging biotech companies are responsible for a large share of new drugs approved by the FDA [4]. These companies often face unique hurdles due to their size and scale, including navigating complex molecules and accelerated timelines tied to funding [4].
The biopharmaceutical market is growing rapidly and is expected to reach $856.1 billion by 2030 [21, 5]. This growth is driven by the increasing demand for advanced therapies like biologics, as well as cell and gene therapies [21, 5]. These complex treatments require specialized manufacturing and delivery methods, adding another layer of difficulty to the development process [7].
2. Typical Market Trends
Several key trends are shaping the drug development landscape.
Outsourcing is on the rise. Many biotech companies, especially smaller ones, are relying on contract development and manufacturing organizations (CDMOs) to handle drug development and manufacturing [22, 8]. This helps them get specialized expertise and resources without the high cost of building their own facilities [22, 8]. The global biotechnology outsourcing market is expected to grow a lot as biopharmaceutical development gets more complex.
Advanced drug delivery systems are in demand. To improve the effectiveness and safety of drugs, companies are using advanced delivery technologies like nanoparticles and liposomes [9]. There's also a move toward more patient-friendly options, such as pre-filled syringes and wearable devices [7, 10]. For biologics, which are often administered through injection, innovations in delivery are particularly important [10].
Artificial intelligence (AI) is transforming the industry. AI is being used to speed up drug discovery, optimize formulations, and improve clinical trial design [11, 24]. By analyzing large datasets, AI can help researchers identify new drug targets and predict how a drug will behave in the body [11, 13, 24]. This data-driven approach can save time and money, and increase the likelihood of developing a successful drug [13].
New modalities are gaining traction. Cell and gene therapies are revolutionizing how we treat diseases by addressing the root cause [21, 5]. These advanced therapy medicinal products (ATMPs) are a rapidly growing segment of the market [21, 5]. Viral vectors, like lentiviral and adenoviral vectors, are commonly used to deliver genetic material in these therapies, but they come with challenges like immune responses and manufacturing complexities [15].
3. Current Challenges and How They Are Solved
Drug development teams face a number of challenges, from scientific hurdles to regulatory complexities.
Formulation challenges. A significant number of drug candidates have poor solubility, which can limit their effectiveness [4]. Early assessment of a molecule's properties is key to selecting the right formulation strategy to improve bioavailability [17]. For new modalities like viral vectors and RNA, formulation is even more critical to ensure stability and successful delivery [15].
Regulatory hurdles. The regulatory landscape is constantly evolving, and companies must keep up with new requirements [1]. Regulatory agencies like the FDA have stringent expectations for CMC documentation, and incomplete or insufficient data can lead to delays or rejection [1]. Partnering with a CDMO can provide the regulatory expertise needed to navigate this complex process [20, 6].
Manufacturing complexities. As therapies become more complex, so does the manufacturing process. For biologics, this often involves sterile filtration and aseptic processing to ensure patient safety [7]. Cell and gene therapies have their own unique manufacturing challenges, including standardizing raw materials and ensuring consistency between batches. Outsourcing to a CDMO with specialized capabilities can help overcome these hurdles.
Time and cost pressures. The pressure to develop drugs faster and cheaper is immense [3]. This has led many biotech companies to seek out partners who can help streamline the development process [20, 6]. By outsourcing to a CDMO, companies can reduce their operational costs and accelerate their time to market [6, 8, 20, 22].
4. How Leukocare Can Support These Challenges
Leukocare is a company focused on drug product development, and they have solutions for many challenges biotech and pharma companies face.
If you're a Fast-Track Biotech Leader needing to quickly get to a Biologics License Application (BLA), Leukocare offers a smart formulation platform and AI-based stability prediction. This means you get a fast, clean path to BLA with a regulatory-compliant, commercial-ready formulation. They're like a strategic co-pilot, not just someone doing the work, helping you through the whole process.
For a Small Biotech with CMC Understanding that might not have its own drug product team, Leukocare ensures clear communication and structured processes. They take a hands-on approach to speed up development for Investigational New Drug (IND) and Phase I, avoiding confusing "CMC jargon" and making sure you truly understand.
For a Mid-size Biotech that might already have partners but is short on time or needs special expertise, Leukocare can jump in to solve tough problems. They can help with things like new modalities or lyostability, and they offer a "proof through pilot" approach to build your trust.
If you're Pharma Tackling a New Modality, and your internal teams might not have experience with things like viral vectors or RNA, Leukocare brings deep technical expertise. They can offer mini-workshops, deep dives, and custom support materials to help your team learn and make decisions that meet regulatory standards.
If you're a CDMO wanting to offer full services without building your own formulation team, Leukocare can be a neutral, external partner. They work independently, stay loyal to your client relationships, and use a flexible, practical approach.
5. Value Provided to Customers
Leukocare helps its customers a lot by addressing the specific problems each type of buyer has.
For the Fast-Track Biotech Leader, the big win is getting to BLA quicker with a strong formulation, all backed by data and set up for regulatory success.
For the Small Biotech, the value comes from having a reliable partner who gives you structure, speed, and real substance, delivering reliable, data-driven results.
For the Mid-size Biotech, the value is a trusted partner who can solve complex problems and get results, building your confidence with a pilot-first approach.
For Pharma Tackling a New Modality, the value is getting a clear guide for your modality journey, complete with real data, expertise, and a custom formulation design, so you avoid generic templates.
For the CDMO as a Network Partner, the value is having a silent, seamless, and science-backed formulation team that always stays loyal to your client relationship.
By understanding what different players in drug development really need, you can offer specific solutions that help get new therapies to patients faster and more efficiently.
6. FAQ
What is CMC and why is it important in drug development?
CMC stands for Chemistry, Manufacturing, and Controls. It's a critical part of drug development that focuses on ensuring the quality and consistency of a drug product [1, 23]. It covers everything from the drug substance and manufacturing process to the final drug product and its packaging [23]. Strong CMC data is essential for regulatory approval [1].
What are some of the biggest challenges in developing new drug modalities like cell and gene therapies?
New modalities present unique challenges, including manufacturing complexity, ensuring stability, and navigating a rapidly evolving regulatory landscape [21, 5]. For viral vectors, potential immune responses are also a concern [15].
How is AI changing drug development?
AI is helping to accelerate drug development by analyzing vast amounts of data to identify promising drug candidates, optimize formulations, and streamline clinical trials [11, 24]. This can lead to more effective treatments and reduce the time and cost of getting new drugs to market [13].
Why are so many biotech companies outsourcing to CDMOs?
Outsourcing to a CDMO allows biotech companies, especially smaller ones, to access specialized expertise and manufacturing capabilities without the significant investment required to build their own facilities [20, 6]. This can help them reduce costs, accelerate timelines, and navigate complex regulatory requirements [22, 8].
