Psoriatic Arthritis treatment attracts attention for Biosimilar development

2nd February 2015

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO,

Like waiting for a bus, there was no effective treatment for psoriatic arthritis then three came along. The literature has been awash with the new treatments; anti-TNF α drugs such as Enbrel and Humira. Janssens anti-IL-12/23 drug Stelara and now the new IL-17 blocker Secukinumab from Novartis. These drugs have clinically demonstrated to be effective More

Current Challenges and Opportunities in Cost Effective and Affordable Biosimilars

27th October 2014

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO,

Biosimilars challenge us in many ways but for me these issues can be divided into those for a scientist, those for the industry and those for the patient. In my job, as a CSO working in Contract Research Organization, I have found Biosimilars have forced us to better understand the biological aspects of these drugs. More

Testing for Human Cytomegalovirus

5th December 2013

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

Human cytomegaloviruses (and simian) are members of a virus family that are specifically identified by the biologics safety guidelines as a specific concern. Most recently the 2010 FDA guidelines for testing of vaccine cell substrate included a recommendation that if there is the possibility of contamination with Human and Simian cytomegalovirus then the in vitro More

Top 10 problems encountered in IND or BLA submissions

24th October 2013

Category: Bioanalytical / Regulatory

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By: Dr Daniel Galbraith, CSO,

During the Well Characterised Biological Congress an FDA reviewer gave us an insight into some of the common problems encountered in IND or BLA submissions with a list of the Top 10 inadequacies. Number 1 – The lack of procedural details contained within the submission. What was clear was that the FDA requires a working SOP More

Prospect of plant based production methodologies for Trastuzumab (Herceptin)

8th October 2013

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO,

The production of Biosimilar Monoclonal Antibodies often follows the same or similar production methodologies to the innovator product, Chinese Hamster Ovary Cells being the most common method. However there is nothing in the current guidelines to prevent the use of other production systems for these products. In the paper published by Grohs et al., 2010 More

Leptospira contamination – How to manage risk

27th September 2012

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

Vaccines and Biologics are recognized to be at high risk of contamination by bacteria and viruses. Over many years the risks have been determined and these products are recognized to be among the safest on the market. In the past there have been a number of viral contamination events which have resulted in increased vigilance More

Anti-TNF-alpha Biosimilars Humira, Remicade and Enbrel

1st March 2012

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO,

Anti Tumor Necrosis Factor (Anti-TNF) drugs, Humira (adalimumab), Remicade (infliximab) and Enbrel (etanercept) are perhaps the most successful of all biologics both with respect to their turnover and the number of patients treated with these drugs. All have been shown in clinical trials to help with improving the clinical outcome of Rheumatoid Arthritis (RA) but More

Bovine Virus Contaminationin Cell Banks used in Biopharmaceuticals and Vaccines

25th November 2011

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

The risk of contamination of biopharmaceuticals and vaccines by Bovine viruses has been well recognized. Calf serum was, and in some instances still is, commonly used to supplement the growth media for cells used in production of many vaccines and some biologics. Although “serum-free” media is frequently used today the risk of exposure to bovine More

Massively Parallel Sequencing in Biopharmaceutical QC Testing – Is it too much information?

13th May 2011

Category: Biosafety

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By: Dr Daniel Galbraith, CSO,

There is a tendency towards conservatism utilising tried and tested methodologies in the safety and QC testing schemes designed for biopharmaceuticals, rightly so. In the early 1990s PCR was a useful research tool and was beginning to be used in targeted adventitious agent testing in cell lines and products, particularly virus vaccines, because of its More

Biosimilars – How similar must they be?

28th April 2011

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO,

The hype over the market for biosimilars remains buoyant; research indicates that the market is likely to be worth almost USD$20 Billion by 2014. This increase is in some part driven by the major Asian players who have well over one third of the market. This push is in many ways due to the strong More

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