In April 2013, biopharmaceutical company Pfenex (San Diego, CA) announced a joint venture with biologics manufacturer Stelis Biopharma, Inc. (“Stelis”), earlier known as Agila Biotech, (a wholly owned subsidiary of Strides Arcolab Limited (Bangalore, India) for the commercial development of six biosimilars. The companies will also leverage technology and global development expertise from GE Healthcare Life Sciences (Uppsala, Sweden) and Bio-XCell Malaysia (Nusajaya, Malaysia). Such international, multicompany collaboration strategies have become a growing trend in the highly competitive biosimilars industry.…
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A Sustainable, Single-Use Facility for Monoclonal Antibody Production
Pierre Fabre, the second largest independent pharmaceutical group in France, recently opened a new facility to expand its monoclonal antibody (MAb) production for clinical supply. The Antibody Biotechnology Unit (ABU) facility was designed to provide needed flexibility for adapting to various process and capacity changes, so it includes state-of-the-art single-use technologies. The facility was also built with sustainability in mind to minimize the company’s environmental footprint. The company integrated this plant into an existing antibody research and development (R&D) center,…
Quality Risk Assessment and Management Strategies for Biopharmaceutical Companies
You’ve probably been hearing a lot about risk assessment in recent months. Indeed, some 15 times more articles have been printed referencing the concept over the past year relative to a 12-month period just three years ago. That truly represents a geometric progression. Unfortunately, very few authors have been able to disambiguate the different methods or provide insight into this time-tested, multiple-industry philosophy that at its core uses good science to make better decisions. When we undertake the challenge to…
Benefits of Business Process Management
The biopharmaceutical sector is synonymous with innovation. There is a general sense, however, that biomanufacturers often don’t “have their houses in order” when it comes to adopting efficient processes, communications, and reporting tools. Indeed, many companies still rely on outdated methods to support areas such as research and development (R&D), manufacturing, clinical trials, and sales and marketing. That is especially true now that the biopharmaceutical sector is undergoing an acquisitory revolution of both rival companies and products. The industry has…
Biosimilar Products
The Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held on 22 January 2012 in San Francisco, CA, focused on selected scientific and regulatory aspects in the development of biosimilar products. Such products are an increasingly important area of interest for both the biopharmaceutical industry and its regulatory agencies. Biosimilars are highly complex, so scientists have been unable to demonstrate identity to a level typically possible for small molecules. Consequently, specific scientific and regulatory approaches are required to ensure the high…
Process Improvements Increase Production Capacity of a Legacy Product
Implementation of postlicensure process improvements in the biopharmaceutical industry can benefit patients and drug manufacturers alike. Here we demonstrate through a case study how a change to the cell culture medium and process can be taken from proof of concept through scale-up to demonstration of feasibility. We further illustrate the scope and complexity of implementing a change in commercial manufacturing to realize significant benefits such as increased production capacity over an existing legacy process. The Importance of Postapproval Improvements Drug…
Impact of Process Interruption on Virus Retention of Small-Virus Filters
Manufacturers of biopharmaceuticals using mammalian cell culture must have processes in place to minimize the likelihood of virus contamination of their products. Regulatory agencies provide guidelines for testing strategies and best practices to assure raw-material safety and control of the manufacturing process. Safety assurance relies on an interdependent matrix of managed risks, including characterization and control of raw materials, extensive testing of process intermediates, and demonstration of the virus removal capabilities of purification unit operations Figure 1: () A dedicated…
Government Medicaid Reporting
On 27 January 2012, the US Centers for Medicare and Medicaid Services (CMS) published a much-anticipated proposed average manufacturer price (AMP) rule for implementing related prescription drug provisions of the Patient Protection and Affordable Care Act (PPACA). The new rule will create serious financial, administrative, and operational challenges for the life-sciences industry. Nearly two years later, the final rule has not been issued. Without official direction, we can look back at the proposed rule’s purpose and recommendations for manufacturers based…
Development Strategies for Novel Vaccines for Infectious Diseases
In a vaccine development program, the probability of success at each transition decreases, even though the actual probability of moving from one phase to another can be 50–80% (Figure 1). Many compounds and vaccine candidates are screened out even before they get into preclinical studies. Developers can implement different approaches to reduce product failure risk before a program gets expensive, including Establishing a product development plan (PDP) Identifying and mitigating risk with gap analysis Learning from the mistakes of others…
Inactivated Poliovirus Vaccine Made in Modular Facilities with Single-Use Technology
If current efforts to eradicate polioviruses worldwide are successful, then the oral poliovirus vaccine (OPV) currently used for routine immunization in low- and middle-income countries (LMICs) will be replaced by inactivated poliovirus vaccine (IPV). IPV will become the only option for such countries if they want to continue to vaccinate against polio (1). Because IPV is currently considered to be too expensive for use in LMICs, strategies are being undertaken to make IPV more affordable (2). Some experts estimate that…