BioProcessing Journal

Outsourcing Molecular Biology Tasks: A Valuable Business Tool for Accelerating Bioprocessing R&D

A significant percentage of new pharmaceutical commercialization activities now focus on biological-based therapeutics. This increasing demand for biologicals necessitates the continued expansion and technological improvement of bioprocessing activities. Bioprocessing plays a critical role throughout the entire drug commercialization process…

Biologics Production

biopharmaceutical industry bioprocess r&d bioprocess research development bioprocessing biotech supply chain drug commercialization dynamics molecular biology pharmaceutical industry

Optimization and Flexibility: Enhancing the Pharmaceutical Supply Chain Through Strategic Warehousing

Optimization, flexibility, and competitive advantage normally aren’t used to describe warehousing operations in the pharmaceutical industry. However, as the industry continues to deal with difficult press, patent expirations, battles with Congress, and intense competition, even the historically unvarying business of warehousing is due for an overhaul…

Biologics Production

active pharmaceutical ingredients api biopharmaceutical industry bioprocessing business warehouse database inventory models pharmaceutical industry warehouse optimization warehousing

Virtual Biopharmaceutical Sourcing: Six Methods for Six Sigma Outsourcing

Despite trepidations, bioprocess oursourcing has come a long way from its inception, which was born in necessity and regulatory fear. Based on primary research that Seraphim and Pharmsource conducted in 2002, the current market for biopharmaceutical manufacturing outsourcing (upstream and downstream production of bulk APIs, but excluding separately outsourced analytics, development, and other services) was $500 to $700 million with a projection to grow to $1.5 to $2.5 billion over the next five years…

Biologics Production

bioprocess outsourcing bioprocessing bulk api downstream production intellisourcing risk management six sigma six sigma outsourcing virtual biopharmaceutical sourcing

Protein Production from Mammalian Expression Systems for Research and Early Development at Contract Facilities — A Primer

In the late research/early development stage of a biologic, it is often necessary to produce a larger quantity of a protein than a company is capable of producing internally. At this stage, the availability of the purified protein may govern its continued development. The protein needs to be produced with a minimal amount of waste; i.e., with a minimal amount of personnel and expense, in the shortest amount of time possible…

Biologics Production

biologics production biopharmaceutical cell culture conditions cmo contract manufacturing organization expression levels protein expression purified protein scale-up

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

Expanding Horizons: Opportunities in Eastern Europe for Contract Research Organizations

The contract research organization (CRO) industry is rapidly adapting to the exigencies of pharmaceutical and biotechnology companies. For a start, the function of CROs is no longer confined to offering only clinical trial outsourcing services. Instead, many CROs now provide a full complement of services that guide products from inception to commercial implementation…

Biologics Production

biopharmaceutical biopharmaceutical research organization cell culture contract research organization cro pharmaceutical

Cell-Based Potency Assays: Expectations and Realities

Among the battery of assays needed to release viral-based gene therapy biologics products, the potency assay is typically the most customized and unique of all the tests found on a Certificate of Analysis (COA). Where many safety, purity, and to some extent, identity assays can be applied with little to no custom modifications, the potency assay should be directly related to the biological activity of the construct. This aspect of the potency assay requires that development, characterization, and validation efforts be started early in the lifecycle of the product, and adequate resources should be allocated to this end. This article will cover a brief overview of available regulatory guidances, discuss hallmarks of a good cell-based potency assay, and provide a case study of an assay that was developed for a Phase 3 gene therapy product…

Biologics Production

cell-based potency assay certificate of authenticity coa fda regulatory guidance gene therapy identity assay phase 3 potency assay viral-based biologic

Standards-Setting for Single-Use Equipment in Biopharmaceutical Manufacturing: An Update on Progress, and the Impact of Standards Implementation

Only a year ago, the lack of standards for single-use equipment systems (SUS), as covered in this journal, was cited as inhibiting growth in the bioprocessing industry. The need to establish more standardized approaches for single-use devices’ design, quality, and leachables/extractables that regulators and industry end-users could accept was slowing the acceptance rate of these novel devices…

Biologics Production

bioprocessing industry extractables leachables single-use equipment sus sus standards

Hybridoma and CHO Cell Culture Using the New Brunswick™ S41i, An Environmentally-Friendly, “Low Emission” Incubator Shaker

Automobiles contribute significantly to CO2 emissions in the atmosphere. However, laboratory equipment such as CO2 incubators can potentially release over 120,000 liters of CO2 gas per year. The “epGreen initiative” established by Eppendorf® will ensure that their products are developed with the mindset of reducing environmental impact…

Biologics Production

carbon dioxide cell culture cho cells co2 environmental compact hybridoma culture

Development of Pregnancy-Associated Malaria Vaccine Using the ExpreS2 Insect Cell Expression System

There are an estimated 225 million cases of malaria each year leading to nearly a million deaths, mostly in children under five years of age. Of the five malaria parasite species that can infect humans Plasmodium falciparum is by far the most virulent, causing 89% of all malaria related deaths in 2008. The P. falciparum parasite escapes the immune system by inserting antigens, functioning as adhesions, into the membrane of the infected erythrocyte. This allows it to sequester in the host microvasculature, thereby avoiding clearance in the spleen…

Biologics Production

malaria malaria vaccine pregnancy vaccine s2 expression system s2 insect cell

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