Traditionally, U.S. life sciences contract organizations have focused on either research (CRO) or development and manufacturing (CDMO). Founded in 2009, LakePharma is defying tradition and has evolved into the first U.S.-based, full-scale CRDMO to provide an integrated suite of end-to-end services for the biologics development community.

Throughout its 10-year history, LakePharma has contributed to the development of hundreds of therapeutic and diagnostic products. The company specializes in the production and evaluation of DNA vectors, viral vectors, cell lines, proteins, antibodies, and conjugates. Its integrated solutions bridge discovery, engineering, preclinical process development, and cGMP manufacturing for Phase I/II clinical trials.

LakePharma is also at the forefront of small-scale GMP manufacturing with its microBiomanufacturing™ approach, which is fast, flexible, and typically with a shorter queue time. Utilizing single-use technology, cGMP production batches can range from 1 gram to 1 kilogram, enabling the rapid advancement of biologic candidates from process development to clinical supply, proof-of-concept testing, and commercial production of certain niche products.

Geographically, the company’s footprint includes six locations in key U.S. biopharma/biotech hubs. Although each facility has a distinct focus, such as the new Worcester-based Vector Center, close collaboration and a state-of-the-art IT infrastructure supports a seamless integration.

Supporting Biologics Development

Hua Tu, PhD, the founder and CEO of LakePharma, offers a personal perspective into the company’s future strategies to best support their customers.

What sets LakePharma apart from other contract organizations?

What distinguishes LakePharma most is its integrated solution services. We can develop products from discovery through GMP manufacturing with all activities seamlessly integrated to minimize gaps in technology transfer. In doing so, LakePharma has evolved the biologics CRO/CDMO business model to a new level—a CRDMO.

A prime example of these capabilities is LakePharma’s development of anti-idiotypic antibodies to be used in companion diagnostics or analyte-specific reagent (ASR) applications. The LakePharma Antibody Center in San Carlos, CA, has completed hundreds of challenging discovery programs by utilizing a variety of antibody discovery technologies from in vivo immunization with DNA to synthetic antibody libraries (in-house or in collaboration with Twist Bioscience). After antibody leads are discovered, we can produce recombinant antibodies and characterize them with a range of functional and biophysical assays to select the best lead to advance to development.

LakePharma offers multiple technology platforms for high yield production of recombinant antibodies.  The TunaCHO™ transient expression platform has been engineered for gram-scale production, while the CHO-GSN™ stable cell line technology platform can generate high-yield stable cell lines that are ready for use in clients’ commercial manufacturing. Clients can purchase commercial use licenses from us for these production platforms, offering a quick, convenient path to commercialization. LakePharma can perform the entire process development (upstream, downstream, analytical, formulation, stability, and release assay) and manufacture the products under GMP conditions for ASR applications. These activities span a wide range of technical expertise and are all performed in LakePharma’s U.S. facilities, solidifying our position as a true end-to-end provider.

What drove the decision to become the first U.S.-based CRDMO?

Building end-to-end capabilities and offering integrated solutions has always been our vision. Clients and the market want a one-stop shop and a partner who can take care of the entire project.

There are several examples of the CRDMO in the small molecule space, so building value as an integrated solution provider is not a new concept. Biologics are inherently more challenging than small molecules and require more technology and expertise to succeed. We have been relentless in developing the technologies to support these functions and have created the most comprehensive technology platform in the industry.

How does the company support the cell and gene therapy markets?

LakePharma performs development and production of adeno-associated virus (AAV), lentivirus, and next-generation gene delivery technologies at our Vector Center in Worcester, MA. Both AAV and lentivirus engineering and production services are in high demand due to the explosive growth in gene and cell therapy, which is only expected to accelerate. LakePharma has developed its own virus engineering and production platforms, designed to offer superior performance when compared to other systems currently available, utilizing high-density suspension cell cultures that are scalable and ready to transition to GMP manufacturing.

The LakePharma microBiomanufacturing™ Center in Hopkinton, MA, provides GMP manufacturing services for plasmid DNA, which can be used as a key ingredient for GMP manufacturing of viral vectors and other biologics. We have developed a flexible plasmid DNA platform that is scalable to meet client needs, ranging from milligram- to gram-scale production.

LakePharma also provides tools for the emerging cell therapy space. In addition to producing plasmid DNA and viral vectors, LakePharma produces proteins and antibodies that serve as key reagents to select, maintain, grow, and stimulate cells. Because the company offers a wide range of technology and production platforms, LakePharma can be a one-stop shop for engineering and production of GMP-grade materials for the cell therapy markets.

What’s next for LakePharma?

Our current focus is to establish additional GMP manufacturing capabilities in biologics, diagnostics, and vector production. We are considering Texas and other states for a potential site to build a campus for Phase III clinical and commercial GMP manufacturing. That will materialize the vision of providing our customers with true end-to-end solutions from discovery to diagnostics and drug products that can benefit patients.

 

To explore more LakePharma’s integrated solutions for biologics, please visit here.

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