FDA – BioProcessing Journal

From the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs”

When I go to a therapeutic protein meeting, it’s very hard for me to hear these products referred to as “drugs.” But since they are being regulated by CDER, it’s a little easier to swallow. However, calling viral gene vectors and cellular therapies “drugs” is a bridge too far. My advice to my good friends at CBER is to keep calling their products “biologics,” or they may lose all of their regulatory responsibilities to CDER…

Biologics Production

biologics bioproduction cber cder cellular therapies drug product FDA monoclonal antibodies odat regenerative tissues subunit vaccines viral gene vector

From the Editor-in-Chief: Good News! The Licensure of Biologics is Really Taking Off

The licensure of biologics is really taking off as we all hoped it would in the ‘90s. There are a number of key factors including the advanced ability to produce adeno-associated virus (AAV) with baculovirus expression technology (BET), as well as the ability of BET to produce antigens that can successfully be used as vaccines. Then of course, there is the first licensed human gene therapy from uniQure, which is based on AAV-1 that was derived from BET…

Biologics Production

aav aav gene therapies adeno-associated virus baculovirus expression technology bet biologics bioproduction conjugated antibodies FDA internal reference assays internal reference materials lentiviral vectors lentivirus

From the Editor-in-Chief: Applying More Automation to Our BioProcessing

As an industry, we need to do far more to implement technologies and work with FDA, not only to keep them informed, but to make sure they are aware of industry trends and newer technologies. Remember that CBER and
CDER have their own labs, and in many cases, they will want to bring in the technologies you want to use and see how they work in their own experiments…

Biologics Production

biologics bioproduction FDA in-process automation in-process testing new technologies pat process analytical technologies process monitoring regulatory considerations reproducibility

From the Editor-in-Chief: “Therapeutic Glyco-Proteins Produced by Living Organisms” or “Drugs”?

“But why are they calling these products ‘drugs?’” I asked at the recent CMC Strategy meeting that CaSSS hosted in Gaithersburg. “Well it’s because they aren’t vaccines or blood products” said an old friend, who is an authority in the field. “But,” I said, “we’re really talking about therapeutic glyco-proteins produced by living organisms.” And just to make sure I was remembering things correctly, I searched Google and reviewed the definitions for a “biologic” and “biological” in several of the top technical references. Truly, a biologic or biological is a substance produced by a living organism, which would include glyco-proteins, non-glycosylated proteins, enzymes, viruses, and broken up proteins which could be used as poly-peptides or simple antigens…

Biologics Production

biopharmaceuticals biotech industry biotherapeutics cber cder drug FDA generic biopharmaceuticals polypeptides process differences small-molecule drugs

Outsourcing Clinical Trial Material Manufacturing: Regulatory and Quality Issues for the Twenty-First Century Biotechnology Product

The United States Food and Drug Administration (FDA) considers antibodies and recombinant proteins as “well-characterized products.” This is based on FDA’s comfort level with reviewing multiple products over an extended period of time. This designation relates to the product, not necessarily to the system that is used to manufacture the product nor to the facility where the product is manufactured. The initial guidance document was published in 1995, prior to the use of other systems and when the majority of products were still based on mouse hybridoma technology that was 20 years old…

Biologics Production

antibodies biopharma guidance documents biopharmaceutical cell culture clinical trial material FDA mouse hybridoma quality issues recombinant protein well-characterized products

Recent Statutes, Regulations, and Court Cases Affecting Intellectual Property Rights of Life Sciences Institutions: Key Provisions of the Leahy-Smith America Invents Act and the Biologics Price Competition and Innovation Act; Part I: Analysis of the Leahy-Smith America Invents Act

Government policies affecting intellectual property rights and the review of food and health care products dramatically influence investments in research leading to the development and sale of products that serve unmet medical needs or provide consumers with safe sources of food and drug products at a low cost. When statutes that affect several regulatory agencies are revised within a short time period, institutions that rely on exclusive rights offered by those agencies in exchange for obligations of disclosure and compliance must alter their business plans to adjust to new rules leading to the benefit conferred by the government. In 2011, the Leahy-Smith America Invents Act (AIA) was passed, changing many aspects of the federal statutes relating to the United States Patent and Trademark Office (PTO), and in 2010, the Patient Protection and Affordable Care Act (PPACA) was passed, which included the Biologics Price Competition and Innovation Act (BPCIA), requiring the United States Food and Drug Administration (FDA) to establish an abbreviated regulatory approval pathway for complex macromolecules produced in living cells or organisms. This series of articles briefly reviews key aspects of the AIA and the BPCIA, plus recent court cases relating to complementary periods of exclusivity offered by the FDA and the PTO, which should be of great interest to academic and corporate institutions having an interest in the life sciences. Important aspects of the AIA will be discussed in the first article in this series…

Biologics Production

affordable care act america invents act biopharma biopharmaceuticals bpcia FDA follow-on biologicals intellectual property rights macromolecules regulatory approval pathway

Continued Process Verification: Monitoring and Maintaining a State of Control

To ensure that a commercial biomanufacturing process is in a state of control, life science companies must create and successfully execute initiatives to meet continued process verification (CPV) and other monitoring guidelines. Management at pharmaceutical, biotech, and medical device companies commonly receive directives associated with data monitoring. Various challenges arise in the development and maintenance of a successful global monitoring program. Because of this, many companies develop data monitoring programs that are not scalable and sustainable. Company leaders struggle with how best to adopt, deploy, and scale monitoring systems to achieve defined quality monitoring goals. The purpose of this article is to display a maturity model to help companies navigate the major steps of implementing a global monitoring plan for continued process verification…

Biologics Biologics Production Mammalian Cell Culture Manufacturing Process Automation

cmo continued process verification contract manufacturing organization cpv data monitoring FDA fda guidelines maturity model meta-monitoring

Improving Biopharmaceutical Manufacturing Yield Using Neural Network Classification

Traditionally, the Six Sigma framework has underpinned quality improvement and assurance in biopharmaceutical manufacturing process management. This paper proposes a neural network (NN) approach to vaccine yield classification and compares it to an existing multiple linear regression approach. As part of the Six Sigma process, this paper shows how a data mining framework can be used to extract further value and insight from the data gathered during the manufacturing process, and how insights into yield classification can be used in the quality improvement process.

Bioinformatics Biologics Biologics Production Research

bioreactor crisp data mining design-of-experiments dm methodologies doe FDA machine learning mvda neural network nn pat pneumococcal vaccine process analytical technology six sigma vaccine yield classification who

Improving Process Economics When Developing a Vaccine Portfolio

Over the last few years, the challenges of vaccine development have created perhaps an unprecedented level of scrutiny, not just within the biotech industry, but also in the consciousness of the general public. This was certainly the case during the recent H1N1 influenza outbreak. The demand to know when a vaccine would be available, and if producers could meet the global demands consistently made front page news. The challenge of rapid and scalable manufacture is of course nothing new in biopharmaceutical development and in many respects, monoclonal antibodies are leading the way as the industry moves towards the required level of industrialization.

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

antibody production cho cells clinical development cmo complex biologicals contract manufacturing FDA influenza novel vaccines phase 1 phase ii process economics regulatory guidelines risk-based-approach scalable manufacturing vaccine portfolio vaccines

Characterization and Qualification of Cell Substrates for Manufacturing Viral Vaccines in the United States

Cell substrates are used in various stages of viral vaccine manufacturing, as in the isolation, selection, and propagation of the virus seed or virus vector stock, as well as for the amplification of the virus to produce the final vaccine product. The various stages of cell substrate use, including cell banking, are shown in a generic manufacturing scheme in Figure 1. Traditionally, viral vaccines have been produced in animal tissues, primary cell cultures, and cell lines that either have a finite life span, such as normal diploid cells, or a theoretically infinite life span, as achieved with continuous or immortalized neoplastic cells. The cell substrates used in viral vaccines currently licensed in the US are listed in Table 1…

Manufacturing Viral Vectors

cell substrates characterization FDA safety testing vaccines viral vaccines

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