White Papers


Solutions for Purifcation of Fc-fusion Proteins

Platform processes are valuable tools in process development. Applying them to complex fusion molecules made up of different structures, however, can lead to unexpected results. EA2 is a unique engineered molecule, and it did not fit well into a platform process. It does, however, have three potential affinity and pseudo-affinity sites, each target site having a platform purification unit operation. One site is the antibody Fc region for Protein A binding, but the product was too sensitive to low pHs for typical Protein A elution conditions, so a high pH elution process was developed instead. The other two pseudo-affinity sites proved to be unusable, as did ion exchange chromatography. The final process that was developed added hydrophobic interaction and mixed mode (HIC and AEX) chromatography polishing, with a solvent and detergent (S/D) treatment instead of the typical lowpH virus inactivation.This product points out the need for innovation and flexibility in cases where platforms do not work.
Click here to download article

Single-Use Technologies
A Contract Biomanufacturer’s Perspective

The closed and controlled environment of single-use technologies in a biopharmaceutical production process can significantly reduce processing time. A fully disposable option eliminates cross contamination, cleaning, and subsequent validation, reducing the use of water for injection. Lower operating costs, smaller equipment footprints, increased productivity, and rapid turnaround time are some of the major benefits that are driving the market demand for single-use technology in manufacturing. This article discusses a contract manufacturing organization’s perspective on the use of disposable technology in the biopharmaceutical production process.
Click here to download article

Cutting costs with contract manufacturing

Leading biopharmaceutical companies are finding that manufacturing and production offer tremendous opportunities to cut costs, reduce time and achieve overall excellence, and pharma companies eager to speed drug development cycles are increasingly turning to contract manufacturers to help streamline the process. But what challenges do they face in terms of choosing an outsourcing partner? And what issues need to be taken into consideration…
Click here to download article

Considerations for Aseptic Filling of Parenterals

Careful planning, innovative machine design, and rigorous attention to
detail will assure maximum product delivery and minimize timelines from project
initiation to completion. By the time a parenteral product arrives at our facility for
filling, a client has invested considerable time and significant resources in its
development and manufacture. Our experiences clearly demonstrate the
importance of planning and attention to detail for achieving a filling run that
enables that product to move efficiently to testing or market, helping to realize
the greatest value from…
Click here to downloa article

Bioprocessing and Partnering

There are a number of challenges facing the biomanufacturing industry,
from both the contract manufacturing organisation (CMO) and industry
perspectives. Biomanufacturing is a complex, labour-intensive and expensive
process and therefore it is extremely important to understand and balance
capacity versus demand and staffing level. Identifying, hiring, training and
retaining properly qualified personnel are very critical to the successful operation
of a facility, since biomanufacturing requires a very specialised and experienced
workforce. Staff must have technical expertise in specific areas including
upstream or downstream current Good Manufacturing Practice (cGMP)
manufacturing operations, process development, project management,
process engineering, quality assurance, analytical development, quality
control, regulatory compliance, and many other highly specialised functions.
Once on board…
Click here to download article


A rosy outlook for outsourcing biologics

Outsourcing providers have every reason to be happy. With an increasing volume
of new drugs entering the clinical trial pipeline, the usage occasions for contract
services are up. NGP spoke with Laureate Pharma’s Robert Broeze to find out how
he plans to become ‘most preferred CMO’.

Laureate Pharma can look forward to a future as impressive as its past. The contract
manufacturing organization (CMO) achieved record growth in 2006. It signed 14 new
agreements and increased its business backlog by more than 240 percent over 2005.
“We also increased our company workforce by more than 25 percent to handle the
ever-increasing workload. We are on track to completing the facility expansion,
and have added a new pilot production plant to expand the purification production
capacity,” says Robert J. Broeze, President and CEO.
Click here to download article


Facilitating Technology Transfer to Your CMO: How to ensure smooth technology transfers.

The following is a transcript of a podcast interview of Dr. Michael Ultee by BioPharm International, recorded at the 2008 BIO International Convention held in San Diego.

BioPharm: What are the biggest challenges in a technology transfer process? Are the challenges different at different stages of tech transfer?

Ultee: I think they are and they fall under a couple of categories. The first is the technical area. The processes that come to us arrive at different levels of development. If a process is already well developed, then it is essentially a pure technology transfer…
Click here to read the transcript

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,…