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Labcorp Message (as of July 21, 4:00 p.m. ET)

  • All Labcorp core systems impacted by the CrowdStrike issues are currently back online.
  • Some of our patient service centers and in-office labs may be experiencing technical issues with retrieving orders.
  • We are working hard to resolve this issue.
  • If you have a copy of your order, this will help expedite the process.
  • We appreciate your patience as we work to restore business operations.

Biologics, biosimilars and small molecule development

  • Thousands of biologics studies and over 40 integrated biologics IND/CTA-enabling packages in the last 4 years

  • In vitro characterization of more than 250 biologics each year

     

  • Proven regulatory knowhow— our scientists have participated in the development of the ICH S6 guidelines

Biologics: Development & Testing

Every biologic molecule is uniquely developed, so we offer a dedicated team of experts to partner with you. Together, we will address the complexities of your molecule to transform data into actionable insights.

Your biologic requires a unique solution. Let’s create it together.

With no two biologic molecules and no two studies alike, it helps to partner with a cross-functional team of experts who deliver proven expertise. Our biologic specialists in CMC, Candidate Optimization, Safety Assessment and Bioanalysis are led by a solutions director with more than 10 years of biologics development experience. You’ll get a custom strategy and accomplished leadership dedicated to your molecule’s success.

Maximize your biologics program. Maximize Your ROI.

Maximizing your biologic program to deliver the greatest value from your development investment is more than just our specialty – it’s our priority. Whether your goal is commercial approval or sale of your molecule prior to Phase I, our team of dedicated biologics solution experts can develop a unique program to maximize your results and yield the most value from your asset. 

Put your energy into what you do best.

Just as there are no two molecules alike, there are no partner needs that are the same. You are the expert for your compound and we are the experts in helping you develop it as quickly and efficiently as possible. Together, let’s develop the best path for your biologic.

Given the specialized nature of biologic development, you’ll benefit from the broadest set of capabilities across the industry. With full-service lab capabilities on three continents, our team serves as a true extension of your own lab personnel, providing you access to end-to-end development solutions that stretch your limited resources farther.

Biosimilars: Development & Testing

Access innovative solutions at any stage in your biosimilar program – from early research through commercialization – with an experienced partner that can offer complete, strategic support.

  • Leverage our experience working on more than 100 unique biosimilars of 23 innovator products

  • Generate robust analytical data to assess biosimilarity at any stage in development

  • Access clinical development and payer expertise focused on your therapeutic area

Realize the market potential of biosimilars

With over 40% of today’s molecules developed as biologics, biosimilars represent a growing opportunity with significant market potential. However, developing a biosimilar and achieving market success is not a straightforward, one-size-fits-all process.

As the only CRO that can provide an integrated biosimilar development solution starting with CMC analytical characterization through nonclinical, clinical and market access activities, we can offer a holistic strategy and cross-functional expertise to optimize your biosimilar’s development. 

Navigate the regulatory landscape

During biosimilar development, many key issues need to be considered based on current regulatory guidance. You need a partner that can help you understand the requirements of different regulatory authorities, the important differences between EMA and FDA guidelines and to keep up with evolving recommendations. Working together, we can help prepare you for agency meetings and enable early engagement to help reduce your time and cost of navigating the global regulatory landscape.  

Get support from early phases through commercialization

Getting market access support – early in development – is another crucial area to achieving success in biosimilars. Rely on our experts to help you create a strong, analysis-based similarity package that considers the needs of payers, providers and patients so you can fully realize the value of your product.

Together, we can assess the competitive landscape and design a strategy for reimbursement that maximizes your market potential.  

Tap into extensive CMC

Controlling variability and assessing biosimilarity is the first step in a biosimilar’s successful development. Trust in our robust analytical approaches to enable physicochemical characterization, assess biosimilarity and identify risks by using the most optimal, fit-for-purpose testing methods.

Take advantage of our Biosimilar CMC Analytical Master Files – unique guides that serve as the foundation for risk-mitigated biosimilarity assessment, client data evaluation and consultation to support your biosimilar program throughout its development and product lifecycle. When your product reaches the market, we’ll help you maintain its availability through our GMP global batch release and stability testing. 

Get expert support for your nonclinical and bioanalytical needs

As the only CRO that can provide an integrated biosimilar development solution, your program is covered – from the very start. Let us support your nonclinical needs with in-vivo studies (efficacy/pharmacology, pharmacokinetic (PK) and toxicity), bioanalytical method validation and sample analysis, and immunochemistry including anti-drug antibody (ADA) and neutralizing antibody (NAb) assessment in animal and human matrices

Shorten timelines by streamlining Phase I and III studies

When you partner with a proven CRO, expect more than biosimilars expertise. With Labcorp, you’ll benefit from our global strategic partnership that includes the largest healthcare and research networks, with investigators experienced in biosimilars.

Our four global clinical research units and three hospital alliances have a combined 400-bed capacity to handle the needs of your phase I trials.

We’ll also help you work with the right clinical sites to deliver your patient studies by using real-world data from our Xcellerate® Informatics Suite that identifies investigators with deep experience testing biosimilars and compounds in your therapeutic areas. As a result, you’ll make smarter site selection decisions, boost your recruitment rates and optimize your clinical trial.  

Small Molecule Development

  • An experienced team delivering more than 60 IND/CTA enabling packages each year

  • Decision-driving insights with an unsurpassed program management function

  • Study designs that result in an average of 20% savings without compromising quality

Having worked on 100% of the top 50 best-selling drugs available today, we help maximize the full potential of your molecule. From lead optimization through commercialization we partner with you to deliver decision-driving data along the development journey.

Helping you make it happen.

You need a solutions provider with a deep appreciation of both the challenges and the potential of your molecule. Having delivered the largest volume of drug development data in the world, we understand why developing your molecule requires tailored solutions at every stage. Find out how our small molecule solutions help our clients identify new approaches to improve study designs and anticipate development challenges as they evolve. 

Solutions tailored for you.

It takes specialized capabilities and extensive resources to develop a small molecule. Having these resources internally is often prohibitive yet outsourcing them means you have to manage multiple providers. From lead optimization through commercialization, we give you access to end-to-end development solutions that can stretch your limited resources farther and access a true extension of your own lab personnel.