Who are the competent biomanufacturers?

by Nick Hutchinson

Once upon a time, this seemed like a very easy question to answer. Engineering companies designed facilities with stainless steel equipment to the user requirement specifications of their biomanufacturing customers. These biotech companies then operated the facilities, producing quantities of product to supply the market. They understood these products, having developed them in-house, and had designed, characterized and scaled-up the required bioprocess. They put in place the quality systems necessary to ensure the safety of their patients. In short, these biopharma companies were vertically integrated with competencies in developing, producing and marketing their products in a tightly regulated market. To better serve their customers they invested in manufacturing sciences leading to process innovations that lowered costs, increased throughput and improved product quality.

Leading biopharmaceutical firms still see biomanufacturing as a core competence. Amgen, to give one example, proudly states in its 2016 Annual Report that the company’s “long record of delivering reliable supplies of high-quality medicines with improving efficiency is a source of differentiated competitive advantage”.

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Innovative Methods for Quantitating Host Residual DNA in Biologic Drugs

“Every lab that does host residual DNA from biologics should use the direct method, it will reduce work time and increase accuracy.”

Musaddeq Hussain Ph.D., Principal Scientist of Bioprocess Development at Merck Research Laboratories joined us at Biotech Week Boston to discuss innovation in quantifying host cell DNA for biologics. In this interview, he delves into the new state of the art methods of quantifying host cell DNA for biologics, which of those methods are especially useful improvements, the types of products that require customization, where new/more sensitive technologies are needed, and the existing solutions that companies don’t know they can take advantage of. To hear Dr. Hussain’s exclusive insights on these key industry trends, access the complete interview now.

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Manufacturing Biologics: Challenging & Expensive

Suresh Choudhary, Associate Scientist II of Formulation Sciences at MedImmune will be joining the speaking faculty at the upcoming Bioprocess Internation Conference & Exposition this October in Boston, MA. Suresh was kind enough to sit down with the KNect365 Bioprocessing team to discuss the challenges associated with manufacturing biologics and other current trends he sees as important in the industry.

He began by addressing the topic holistically and said, “Manufacturing biologics is very challenging and expensive.” but continued on to note that the driving force behind all of this is getting to market as quickly as possible.

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Developing novel therapeutic stem cell expansion platforms: Know your product

by Bart Vaes, Group Leader, ReGenesys

Therapeutic products require thorough quality testing to demonstrate safety and efficacy. For stem cell based products this is of particular importance, as they are of extreme complexity in comparison with other biologics such as proteins or peptides. Although cell characterization is essential for lot release, its role in the product and process development path is at least of similar importance.

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The Impact of Glycan Variation on the Biological Activity of Biosimilar Monoclonal Antibodies

by Daniel Galbraith, Chief Scientific Officer, Sartorius-Stedim BioOutsource Limited

The advent of a new class of drugs “biosimilars” has driven a revolution in biologics. Until 2006 biologics were seen as a class of drugs almost exclusively used in high cost Western medicine. These drugs were expensive to develop and expensive to produce, but more importantly were unable to be copied so the generics market seen in the small molecule drug field was not an option. This proposition was blown out of the water by Sandoz who took these preconceptions head on and with diligent scientific effort and close discussions with the regulators the first biosimilar in Europe was approved. Since that time the floodgates have opened with companies trying to develop copies of drugs that have lost their patent protection. It is difficult to find anyone in the pharma industry today who does not have a project or partnership in the biosimilar market, and this phenomenon is not exclusive to the Western market anymore – the expansion is truly global.

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3 Biologics Industry Predictions from 2015 vs the 2016 Reality

For an industry as fast-moving as the biopharmaceutical industry, it is always interesting to look back at past predictions and to compare them to where we currently find ourselves. Last year we sat down with Günter Jagschies, a Senior Director at GE Healthcare Life Sciences, to discuss the trends in different sectors of biopharma. Here we look though Jagschies’ predictions from 2015 and compare them to state of the industry today.

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How to Master Data Management during Bioproduction?

With the advancements in technology we are able to make better and wiser decisions that can impact the way we develop products nowadays however with better analytics comes more data and the question now is how to manage this. We asked Jarrod Medeiros, Product Specialists at the leading data management company IDBS about their thoughts on the subject and what advice they could share.

Jarrod

Informa: you recently published a white paper on the subject. Why was that?

IDBS: Because we wanted to educate the community on some of the problems we’ve solved for similar customers.

Informa: How can ineffective data management impact the development of biologics?

IDBS: There are a few effects. A major one is efficiency, we’ve found through working with various customers that a large portion of scientists’ time is spent looking for data, transcribing data, and other low value activities associated with paper notebooks, binders, and MS Excel. Another big effect we’ve seen is on quality. This includes the quality of the data itself which can be compromised due to hand writing and transcribing between systems. But also the quality of the output, when data is ineffectively managed the reports and analyses that can be done are limited.

Informa: What advice would you give to industry to handle the vast volumes of data produced in biological development?

IDBS: Use E-WorkBook?! Come talk to us!? I suppose the first step is to admit it is a problem, and then work with vendors that have expertise in solving these challenges.

Informa: How should data management systems be applied to improve decision making in the development and manufacturing of biological products?

IDBS: One of the largest impacts on decision making comes from the ad-hoc analyses that can be done. It’s easy to prepare data and visualizations that need to be used regularly, but when something unexpected happens it is time consuming and sometimes impossible to pull data together in an ad-hoc manner. Data management systems should capture the relationships and context required to be able to quickly view traceability and make decisions.

Informa: What do you see as the best strategies for gaining insight from the increasing amount of data generated and translating this data into knowledge outcomes for products and processes?

IDBS: The best strategy is to move away from a paper and MS Excel-based process as soon as possible. The longer you wait to implement an electronic system for data management, the more of your historical data continues to be in an unusable state.

Join us at BioProduction 2015 to hear more from Jarrod Medeiros, where he will be presenting on leveraging laboratory informatics for the bioprocessing industry on 15th October at 12:05.