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Deploying Automated Buffer Production for cGMP Use: Points to Consider

by Amos M. Tsai, Enrique Carredano, and Karolina Busson
Volume 18, Open Access (January 2019)

Biopharmaceutical manufacturing often takes place in tank farms – facilities in which large-volume vessels are used to support cell culture processes with equally sized, or even larger buffer preparation and storage tanks to support downstream processing. While the large cell culture vessels used to produce products are justifiable, current downstream buffer management approaches relying on high-capacity tanks lead to constraints on facility construction, operations, and plant flexibility....

Tsai AM, Carredano E, Busson K. Deploying automated buffer production for cGMP use: Points to consider. BioProcess J, 2019; 18.

Posted online January 8, 2019.

Investigation of an Adventitious Agent Test False Positive Signal in a Plant-Derived Influenza Vaccine

by Todd L. Talarico, Michael Murphy, Raymond Nims, Dan Hastings, Jeri Ann Boose, and Dave Dumers
Volume 17, Open Access (October 2018)

Medicago manufactures influenza vaccine virus-like particles (VLPs) in an unusual production platform consisting of Nicotiana benthamiana plants. During the in vitro adventitious agent test (AAT) of certain Medicago B strain influenza vaccine VLP test samples, positive hemagglutination of guinea pig red blood cells was observed on day 14, but not on day 28. The positive result in the assay was surprising because the production process uses no animal-derived raw materials and contains a viral inactivation step. Plant-associated viruses would not be expected to infect the mammalian cell-based assay. No cytopathic effects or hemadsorption of red blood cells was observed in these AATs. The positive hemagglutination was observed at 2–8°C, but not at 36–38 °C, and only in a few of the six detector cell lines used in the assay. Because this is quite an unusual pattern of responses for an AAT, Medicago and the contract testing lab, Eurofins Lancaster Laboratories (ELLI) investigated the positive responses thoroughly for the presence of an adventitious agent or an alternative explanation not involving a viral contaminant. Investigation results indicated that the hemagglutinating activity associated with the vaccine test sample itself was responsible for the positive hemagglutination response. The positive hemagglutination on day 14 of these AATs was deemed an assay artifact, and preventive actions were taken to prevent recurrence of this type of false positive response...

Talarico TL, Murphy M, Nims R, Hastings D, Boose JA, Dumers D. Investigation of an adventitious agent test false positive signal in a plant-derived influenza vaccine. BioProcess J, 2018; 17.

Posted online October 31, 2018.

Fetal Bovine Serum and the Slaughter of Pregnant Cows: Animal Welfare and Ethics

by Ole Bødtker Nielsen and Percy W. Hawkes
Volume 18, Open Access (January 2019)

This article examines two interrelated animal welfare topics: the transportation of pregnant cattle, and the collection of fetal bovine serum (FBS). The occurrence of pregnant cattle at slaughter is unavoidable because of health, management, and economic reasons, or because farmers may be unaware of their pregnancy status. Since cattle are often sold to slaughterhouses through intermediaries, the pregnancy status of the cow is usually unknown until after it has been slaughtered and the uterus exposed. In slaughterhouses where fetal blood is collected, technicians are responsible for the detection and proper handling of fetuses, making sure they remain inside the uterus until dead, or are immediately euthanized. The harvesting of fetal blood also provides a possible source of information, which upon request, may help farmers improve the management of their livestock operations. The serum industry endorses the animal welfare standards set forth by the World Organization for Animal Health (OIE), as well as all existing local and national standards relating to the transportation of pregnant cattle and the collection of fetal blood. This article concludes that there is nothing negative or unethical about collecting blood from a dead fetus. Rather it would be unethical not to utilize available fetal tissues obtained from the slaughter of pregnant cattle, especially since FBS, used as an ingredient in cell culture media, contributes greatly to the advancement of the life sciences industry, as well as the replacement and reduction of live animals used in research and testing...

Nielsen OB, Hawkes PW. Fetal bovine serum and the slaughter of pregnant cows: animal welfare and ethics. BioProcess J, 2019; 18.

Posted online January 10, 2019.

A Suspension Vero Cell Line for Production of Viral Vaccines and Viral Therapeutics

by Steven Pincus, Cari Sadowski, Emigdio Reyes, and John Madsen
Volume 17, Open Access (October 2018)

Fujifilm Diosynth Biotechnologies (FDB) is a global contract development and manufacturing organization (CDMO) with over 25 years of experience in process development and/or manufacturing of greater than 310 molecules at sites in: Billingham, England; Research Triangle Park, North Carolina; and College Station, Texas. At our College Station location, we specialize in the development and manufacture of virus-based vaccines (attenuated or recombinant viruses), oncolytic viral therapies (such as adenovirus, polio) and gene therapy vectors (such as adeno-associated virus [AAV])...

Pincus S, Sadowski C, Reyes E, Madsen J. A suspension vero cell line for production of viral vaccines and viral therapeutics. BioProcess J, 2018; 17.

Posted online October 17, 2018.

ICH Q12 Should Build on the ICH Q8 Design Space

by Mark F. Witcher, PhD
Volume 17, Open Access (September 2018)

The current draft of ICH Q12 appears to have taken several steps backward in the pursuit of the manufacturing excellence initiated by ICH Q8 (R2) pharmaceutical development and expanded by FDA’s 2011 process validation guidelines...

Witcher MF. ICH Q12 should build on the ICH Q8 design space. BioProcess J, 2018; 17.

Posted online September 5, 2018.

Hepatitis B Surface Antigen Particle Purification by Immunoaffinity Chromatography Based on CDI-CB.Hep-1 mAb Monolithic Supports

by Rodolfo Valdés, Urh Černigoj, Eduardo Sánchez, Daily Hernández, Blass Nemec, Miladys Limonta, Miguel Castillo, Bárbara Pérez, Urška Vidic, Jana Vidič, Mirjan Žorž, Andrés Tamayo, Leonardo Gómez, Williams Ferro, Yurisley Aldama, Nika Lendero Krajnc, Daniela Marc, and Aleš Štrancar
Volume 17, Open Access (June 2018)

Bead matrices have been used in affinity chromatography to purify molecules in multiple applications. For instance, the hepatitis B surface antigen (HBsAg) is one of the molecules purified by this technique for human vaccine development programs. However, the use of monolithic supports have emerged as the advantageous choice for affinity chromatography based on convective mass transfer, a high number of channels, and low backpressures at high flow rates. For this reason, several experiments were conducted to determine the suitability of CB.Hep-1 monoclonal antibody (mAb) immunosorbent developed on carboxyimidazole (CDI)-monolithic supports (ligand concentrations: 0.5, 1.0, and 7.0 mg/mL) for HBsAg particle purification. Key results from this study show the highest amounts of HBsAg adsorbed (3059.31 ± 865.71 μg HBsAg/mL immunosorbent, n = 2), and HBsAg eluted (2884.50 ± 541.01 μg HBsAg/mL immunosorbent, n = 2), were estimated in the 1.0 mg/mL-CDI-CB. Hep-1 mAb monolithic support immunosorbents. In addition, the ligand leakage was always < 3 ng mAb/μg HBsAg (approved limit) in the 1.0 mg/ mL-CDI-CB.Hep-1 mAb immunosorbents. Experiments also evidenced the high purity and molecular homogeneity of purified HBsAg particles (< 95 %) across 20 purification cycles. Therefore, the ligand concentration could be reduced up to 1.0 mg/mL, which would enable a notable decrease in the mAb amount required for vaccine manufacturing, as compared to bead matrices (4.0 mg/mL). This study demonstrated that CDI-CB.Hep-1 mAb monolithic support immunosorbents are best suited for assessing the large-scale purification performance of HBsAg particles for human vaccine development programs at low ligand concentration and high flow rates...

Valdes R et al. Hepatitis B surface antigen particle purification by immunoaffinity chromatography based on CDI-CB.Hep-1 mAb monolithic supports. BioProcess J, 2018; 17.

Posted online June 5, 2018.

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