Case Study

At Laureate Pharma, Inc. we provide quality-driven solutions in order to deliver our clients’ protein therapeutic drugs successfully time after time. We have overcome unique challenges in each case and we share with you some examples of our successful projects.

cGMP Production of antibodies –
from a vial of cells to bioreactor cGMP Scale-up


A biotechnology company with a focus on development of monoclonal antibody-based therapies for treatment of various diseases approached us to produce pre-clinical material
for toxicology studies as well as cGMP material for Phase 1 studies.

The Challenge

Our client company had a well-developed process that was ready for technology transfer. They had completed cell line development and media development and were successful in scaling up to small-scale (5L) bench-top bioreactors. However, they had no capability for large-scale production of their biotherapeutics. The client wanted Laureate to complete tech transfer and generate toxicology materials within 6 months, followed by production of Phase I materials within 9 months.

Laureate Solution

The amount of cGMP therapeutic material required for Phase I stipulated that we use a 2000L stirred tank bioreactor. We developed a successful process flow starting with a vial of Master Cell Bank cells and scaled them up in sequence in Wave 20L, 50L, 200L and 1000L bioreactors to inoculate our 2000L stirred tank bioreactor for production of product. One of our challenges in the process was to scale-up the high density and high antibody yielding CHO cells in the 1000L Wave bioreactor® to generate inoculum for the 2000L stirred tank bioreactor. To sustain the maximum viability of the cells in this large vessel, we developed optimal mixing speed by adjusting both the angle of rocking and the rock rate. Using this model we prepared the entire seed train using Wave disposable bioreactors and generated inoculum for the 2000L production reactor. The scale-up was successful and the process yielded the desired amount for phase I clinical study for our client. By using single-use technologies such as Wave bioreactor we were able to eliminate time and resource consuming clean-in-place procedures and streamline the entire manufacturing process. We completed the optimized scale up process within the time frame and the budget as stipulated by our client.

Successful Outcome:

We matched the cell growth curve done at bench scale to large-scale process and the cell growth profile closely matched that of the client’s runs. We successfully supported the high density and high titer 2000L bioreactor. We delivered Phase I clinical material within the timeline with increased productivity and efficiency and on budget.

Striving to be your #1 preferred partner in biomanufacturing.

[email protected]

Pharmacy News

Empowering Health Care with US Biopharmaceutical Services

The Role of US Biopharmaceutical Services in Empowering Health Care US biopharmaceutical services play a crucial role in enhancing and empowering the field of healthcare by offering a range of valuable services that contribute to improving health care outcomes. These services are essential for the pharmaceutical industry as they provide support and expertise in various aspects of medical research, development, manufacturing, and distribution. Firstly, biopharmaceutical services are instrumental in accelerating…

The Strategic Impact of Biopharmaceutical Services on U.S. Health Outcomes

Overview of Biopharmaceutical Services Biopharmaceutical services encompass a wide range of activities that contribute to the development, manufacture, distribution, and support of pharmaceutical products. These services play a crucial role in the overall healthcare system, improving health outcomes for individuals and communities across the United States. One of the key components of biopharmaceutical services is drug development. This involves the discovery and testing of new drugs, from initial research to…

The Synergy Between Biopharmaceutical Services and Healthcare

Importance of Biopharmaceutical Services in the Healthcare Industry Biopharmaceutical services play a crucial role in the healthcare industry by bridging the gap between research and patient care. These services encompass a range of activities, including drug discovery, development, manufacturing, and distribution. Integrating biopharmaceutical services with healthcare systems is of utmost importance as it improves patient outcomes and enhances the overall healthcare experience. In today’s fast-paced world, where medical advancements are…

The Impact of Biopharmaceutical Services on U.S. Healthcare Delivery

Importance of Biopharmaceutical Services in U.S. Healthcare Delivery Biopharmaceutical services play a crucial role in providing advanced treatments and therapies to patients, contributing significantly to improving healthcare outcomes in the United States. These services address unmet medical needs and develop innovative drugs that have the potential to save lives and improve the quality of life for patients. One of the key contributions of biopharmaceutical services is their economic impact on…

Enhancing Accessibility Through Online Pharmacies in the USA

Overview of online pharmacies in the USA Online pharmacies have become increasingly popular in recent years, revolutionizing the way individuals access their medications. These digital platforms offer a convenient and cost-effective alternative to traditional brick-and-mortar pharmacies. One of the key advantages of online pharmacies is their convenience. Unlike traditional pharmacies, online pharmacies operate 24/7, allowing individuals to place medication orders at any time that fits their schedule. This eliminates the…

Pioneering Health Solutions through Biopharmaceutical Services in the USA

Extensive Research and Development Initiatives In order to pave the way for pioneering health solutions through biopharmaceutical services in the USA, it is crucial to prioritize extensive research and development initiatives. Biopharmaceutical companies must invest significant resources into discovering new drugs, investigating potential treatments, and exploring innovative technologies. By fostering a culture of scientific curiosity and collaboration, biopharmaceutical companies can create an environment conducive to groundbreaking discoveries that have the…

Biopharmaceutical Breakthroughs in American Healthcare

Overview of Biopharmaceutical Breakthroughs in American Healthcare Biopharmaceutical breakthroughs in the United States have brought about a revolution in the healthcare industry, providing innovative solutions for previously untreatable diseases and significantly improving patient outcomes. These advancements have played a crucial role in shaping the American healthcare landscape. The significance and impact of biopharmaceutical breakthroughs cannot be overstated. These advancements have paved the way for groundbreaking treatments and therapies that have…

Enhancing Healthcare Through Biopharmaceutical Services

Understanding the Role of Biopharmaceutical Services in Healthcare Biopharmaceutical services are essential components of the healthcare industry, playing a crucial role in the development, manufacturing, and distribution of biopharmaceutical products. These services have a significant impact on patient outcomes, medication quality and safety, as well as overall healthcare efficiency. One of the key contributions of biopharmaceutical services is improving patient outcomes. Through the development of innovative drugs and therapies, biopharmaceutical…

The Impact of Digital Health on US Online Pharmacies

Overview of Digital Health and its Benefits for Online Pharmacies Digital health encompasses various technologies and digital tools that are used to provide healthcare services. It includes telemedicine, wearable devices, health apps, electronic health records, and online pharmacies. Online pharmacies are an important aspect of digital health, allowing individuals to access medications and healthcare products conveniently through online platforms. One of the key benefits of digital health for online pharmacies…

The Integration of Online Pharmacies in Health Care Systems

The Importance of Online Pharmacies in the Healthcare Industry Online pharmacies have emerged as a crucial component in the healthcare system, offering convenience, accessibility, and cost-effectiveness to consumers. With the advancements in technology, the recognition of online pharmacies has grown significantly, highlighting their potential to enhance patient care and outcomes. One of the key advantages of online pharmacies is their convenience. Patients no longer have to travel to physical pharmacies,…

Key Drivers of Growth in the US Biopharmaceutical Industry

Growing Demand for Innovative and Personalized Treatments in the US Biopharmaceutical Industry The US biopharmaceutical industry is experiencing significant growth due to the increasing demand for innovative and personalized treatments. Patients are increasingly seeking more effective and targeted therapies for various diseases and conditions, leading to a rise in the demand for personalized medicine. Advancements in technology and research have enabled the discovery and development of new drugs, which has…

Optimizing Health Outcomes with Online Pharmacies in America

Benefits of Online Pharmacies: Convenient, Cost-saving, and Accessible Online pharmacies offer a wide range of advantages that can greatly optimize health outcomes for individuals in the United States. These benefits include convenience, cost-saving opportunities, increased accessibility to medications, and the ability to compare prices and find the best deals. One of the key advantages of online pharmacies is the convenience they provide. Unlike traditional brick-and-mortar pharmacies, online pharmacies operate 24/7,…