Over the last decade, the clinical research and drug development space has undergone transformative changes due to continuous technological advancements and innovative applications. Today, as the COVID-19 pandemic continues to disrupt personal and business activities across the globe, the pharma sector's conventional operations are witnessing a shift from decentralized to digital, highly efficient processes. And at the center of this transition are contract manufacturing organizations that provide state-of-the-art research, development, and manufacturing services to assist drug developers and pharma companies in meeting their tight deadlines and keeping up with the surge in customer expectations.
However, as most contract manufacturing organizations only offer solutions that improve the efficiencies of one specific facet of the overall drug development process, pharma companies must collaborate with multiple partners to holistically strengthen their processes and efficiency. As an antidote to this problem, some pharma firms have developed in-house technological capabilities. But replacing age-old and deeply rooted processes is a time-consuming and expensive endeavor, which hinders C-Suite executives from efficiently utilizing organizational resources and gaining positive ROI.
California-based LakePharma is addressing this growing need for unified contract services with a first-of-its-kind CRDMO (contract research development manufacturing organization) portfolio that includes end-to-end clinical research, development, and manufacturing. The company's unmatched industry know-how and its highly experienced team make them a specialist in the CRDMO space. "We are a one-stop shop that offers end-to-end services for biologics drug development, from research and discovery to development and manufacturing," says Dr. Hua Tu, Ph.D., president and CEO of LakePharma.
Starting the World's First 'Biologics CRDMO'
The journey of LakePharma goes back to 2009 when Dr. Tu recognized the imminent opportunity that the emerging biologics market would create for the larger pharma and drug development arena. After spending over a decade as a molecular biology specialist at Amgen, the California-based global leader in biopharma/biotech, Dr. Tu predicted the explosion of biologics in the pharma arena and decided to develop a platform that offered services for all of the sector’s biologics needs. Currently, the company has expanded its operations from California to Massachusetts and Texas and grown its portfolio to offer more integrated solutions for engineering and GMP manufacturing.
Today, most contract manufacturing organizations in the pharma industry market their services based on their technology usage and operation size. LakePharma approaches its clients in a different manner, combining its technological advancements with industry know-how to ensure better outcomes for its customers. Comparing his company with competitors, Dr. Tu draws parallels between contract organizations and hospitals, where he mentions, "If LakePharma were a hospital, I would not describe it based on the number of beds we have, but on the technical expertise and scientific capabilities it leverages to treat patients."
Delivering Truly End-to-End Drug Development
LakePharma's current portfolio has a wide range of solutions that can be leveraged to develop and manufacture a plethora of drug products, including gene and cell therapy products, proteins/antibodies-based drugs, and vaccines, among others. And to deliver on its mission to provide end-to-end drug development, the company has developed several next-gen technology platforms and services, namely CHO based transient and stable expression systems, therapeutic developability analysis, PentaMice hybridoma production, phage and yeast display, in-vitro glyco-engineering (IVGE), and GMP manufacturing.
We are a one-stop shop that offers end-to-end services for drug development, from research and discovery to development and manufacturing
Apart from these solutions, the company has also developed an industry-leading enterprise software system—LakePharma data and process management system (DPM)—to help clients manage all their workflows from a single pane of glass. This informatics system comprises modules to assist LakePharma's clients to manage information from their projects, quotes and PO, sample tracking, document sharing, and more. Additionally, all of DPM's modules are built to comply with the 21 CFR Part 11 regulations for GMP operations, and its integration with other enterprise systems enables clients to access DPM with a single sign-in. From a technology standpoint, LakePharma's DPM has a built-in automated data analytics module to help clients monitor their production in real time and gain data trends and actionable insights in a convenient and straightforward way. "Unlike the old Excel-based data analysis, which is very cumbersome, DPM is much more intuitive owing to its automated visual charting, in-built data analysis, and alerts," states Dr. Tu.
A Proven Customer Success Record
With its unparalleled technological capabilities and comprehensive industry expertise, LakePharma has contributed to the development of 200+ therapeutic or diagnostic products since its inception. In one instance, the company helped Apollos Diagnostics—a subsidiary of Seattle-based Folium BioMed—in developing a new diagnostic rapid test for SARS-CoV-2. After the initial planning, the client decided to leverage the lateral flow assay (LFA), which is the same concept used in over-the-counter pregnancy tests, to bind distinct SARS-CoV-2 viral particles with two different antibodies to produce a visual line indicating positive diagnosis. And unlike the approach leveraged in existing tests—re-purposing SARS-CoV antibodies that were cross-reactive to SARS-CoV-2—Apollos opted to reveal the most immunologically relevant epitopes from the virus to deliver highly sensitive and specific antigen-antibody reactions. Apollos Diagnostics approached LakePharma to develop their new diagnostic test due to the company's proven track record in the field of biologics and diagnostics development. Not long after conceptualizing the novel LFA idea, the antibody discovery scientists at LakePharma immunized a cohort of PentaMice—a proprietary, royalty-free platform comprising five unique strains of immunologically diverse wild-type mice. Kathleen Kennedy, Ph.D., director of R&D at Apollos Diagnostics, highlighted the impact of LakePharma's capabilities and said, "The discovered antibodies were truly remarkable in terms of sensitivity, specificity, and binning. "Since then, the company has been helping Folium to screen lead antibodies and moving them into downstream development and manufacturing. “As a small company we have to thread the needle. Between the regular process and what we needed to move forward, LakePharma satisfied many of our requests”, comments John Alderete, Ph.D., MBA, Founder and President of Folium Biomed, LLC.
Compare DPM with the old way of performing data analysis, which is Excel-based and very cumbersome, and it becomes quite clear how DPM is much more intuitive with its automated visual charting, data analysis, and alerts
In another instance, LakePharma established a strategic partnership with biologic therapeutics developer Akston Biosciences to help them manufacture their second-generation COVID-19 vaccine. This is an ongoing project where LakePharma is set to manufacture commercial quantities of Akston's vaccine candidate AKS-452, which is a protein vaccine for COVID-19. Unlike other vaccines that must be kept refrigerated or even deep-frozen for transport and storage, AKS-452 has been shown to be shelf-stable for weeks at up to 37°C (95°F). Additionally, the vaccine's ability to suppress the receptor-binding domain of SARS-CoV-2 spike protein has been proven to have a combination of benefits over its nucleic acid, viral-vectored, and inactivated counterparts. "LakePharma started working on various COVID-19 activities in February 2020 and was among the first companies to provide recombinantly-produced SARS-CoV-2 spike proteins for diagnostic and therapeutic development," adds Dr. Tu.
A Culture of Innovation and Excellence
According to Walter Tian, LakePharma’s VP of Commercial Operations, a key component of the company’s success is Dr. Tu's unique leadership and how he puts his entrepreneurial and scientific backgrounds to great use. "He is never satisfied with the status quo and always drives himself and the rest of us to expand our horizons and find newer ways to expand the idea of LakePharma," opines Tian. He further elaborates how the company's go-getter culture has always been the driving force in evolving the company from a typical CRO to its current status as a revolutionary CRDMO.
Another highlight in the company's track record of success is its ability to establish dedicated and specialized, almost-autonomous arms of operations every time it penetrates a new arena. When establishing a new facility or entering a new market, LakePharma places renowned industry veterans at the helm. As an example, the company recently appointed two experts in the field of GMP manufacturing and regulatory affairs/QA—John Manzello and Lisa Alexander, respectively—as leaders in order to bolster the development and delivery of their GMP services and QA activities. LakePharma’s commitment to establishing centers of excellence is embodied by its five lab facilities across the U.S., each committed to developing specific biologics-based therapeutic components.
A Future of Expanding Horizons
Moving forward, LakePharma is poised to develop additional technical capabilities to meet evolving and ever-growing customer demands. "We'll add more capabilities leaning toward automation and robotics, which will help us enhance our efficiency in helping customers," explains Dr. Tu. On the customer side, the company is driving innovation into its informatics system to strengthen its ability to interact with customers and build better, long-lasting relationships. To achieve this, LakePharma has made significant investments and plans to launch advanced automation systems and an ever-expanding roster of newer, more sophisticated services in the coming months.