Listen to the Cell Culture & Upstream Processing Podcast Series

At BioProcess International Conference & Exposition, the Cell Culture & Upstream Processing track will feature process development scientists, engineers and technical experts sharing their recent achievements in reducing timelines and cost of goods while increasing efficiency and productivity through implementation of disruptive approaches and technologies.

Today, BPI is recognized as the leading bioprocessing industry conference where industry and academia come together annually to share technical, scientific and strategic innovations. BioProcess International Magazine is the exclusive provider of pre-conference podcast interviews with speakers who offer their expert perspective and commentary on the scientific trends impacting Drug Product Manufacturing & Fill-Finish Processing; Cell Culture & Upstream Processing; Recovery & Purification; Manufacturing Strategy; and Analytical, Formulation and Quality.

Prior to the conference, this exclusive podcast series gives you access to three interviews with top industry leaders.

First, Barry Buckland, Senior Advisor, Protein Sciences, discusses development of a scaleable and productive insect cell culture-based process for making Flublok, the First FDA licensed recombinant influenza vaccine. Buckland will be presenting at 11:30 am on Wednesday, October 18th at BPI.

In addition, Michael Butler, Professor, University of Manitoba, talks about modeling of glycosylation – predicting profiles of glycosylation from metabolic data. Butler will be presenting at 1:30 pm on Tuesday, October 27th at BPI.

And, Trent Munro, Principal Scientist, Amgen, discusses high-throughput multi-parametric clone screening approach for the generation of tailored production cell lines. Munro will be presenting at 8:05 am on Tuesday, October 17th at BPI.

Listen to all three interviews here: http://bit.ly/1NfG0CN

These podcasts allow you to get a glimpse of what you will experience and learn while attending along with kick-starting the questions you may have for these speakers at the 2015 BioProcess International Conference & Exhibition in Boston.

Thank you for experiencing the BPI Conference Pre-Event Podcasts and we hope to see you in Boston, October 26-29! For more information about the conference, click here: http://bit.ly/1NCAMSw

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Bioprocess Characterization: An Interview with Graham McGreath, FUJIFILM Diosynth Biotechnologies

Dr Graham McCreath is Head of Process Design at FUJIFILM Diosynth Biotechnologies. In this post, Graham describes the company's approach to process characterization in advance of his presentation at BPI Boston in October 2015.

What is process characterization and how does it fit with the development and scale-up activities associated with new production processes? 

Process Characterization studies are a series of risk assessments and experiments undertaken as part of process validation and are carried out during late stage process development. These studies generate process knowledge and understanding and are used to develop robust control strategies for process qualification and commercial manufacture. The experiments are often carried out at laboratory-scale using qualified scale down models and statistical designs such as DoE. They are typically carried out once the final scale-up is complete when full scale data is useful in qualifying the required scale-down models.

What is special about the way FUJIFILM Diosynth Biotechnologies perform process characterization relative to other organizations? 

FUJIFILM Diosynth Biotechnologies have been carrying out process characterization for over 15 years and have completed more than 24 characterization projects. In that time we have built up considerable experience and expertise that benefits our clients with respect to how process information is generated, evaluated and how this is translated into a control strategy and registration package.  Our scientists and statisticians work collaboratively with clients to formulate and plan out the most appropriate robust approach for their needs balancing resources and timeline against residual risk. We have also developed some in-house QbD software packages as well to support modern process development; for example, our RAPTA (Risk Assessment Process Template Application) packages are FMEA based risk assessment tools that we use with clients as a predecessor to process characterization. The RAPTA tools enables us to identify, prioritize and document parameters that may be important in either a manufacturing process or an analytical method.

What skills or competencies should a manufacturer have in order to effectively characterize a process? 

Having an understanding of current regulatory expectations, engineering principles and how they apply to scale down, good documentation practices are all important competencies. It is also is very useful to have people in the organisation trained in experimental design. Modern DoE packages are becoming more user friendly but a good understanding of the pros and cons of design options and especially the interpretation of statistical data is very important.

As you developed your approach to process characterization were there any traps that engineers should avoid when developing their own approach? 

Generally, our advice would be to have a logical, well thought out plan, good documentation and rationales and not to overlook having a good scale-down model. The analytical methods to be used, where they are going to be applied and their development status should also be considered carefully. There is little point in executing a large experimental program if you don't have faith in your measurements.

Graham’s presentation is scheduled to take place on Thursday, October 29 at 2:30pm as part of the Cell Culture track.

Dr Nick Hutchinson

Join me at #BPIconf

Contact me at nick.hutchinson@parker.com

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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This Week in BioPharma: 8/3-8/7

Here is the top news from the biopharmaceutical industry this week:

Biotechnology is helping to heal Delaware: Nearly 22,000 women will be diagnosed with ovarian cancer this year. Another 14,000 will die from the disease. One Delaware biotech firm is working to change that. In December, Wilmington-based AstraZeneca Pharmaceuticals released Lynparza, a new medicine for women with advanced ovarian cancer. Innovative treatments like Lynparza help Delaware patients live longer and healthier lives. Drug development also keeps Delaware's economy healthy by creating jobs and supporting local businesses. But now, Congress may jeopardize the health of our state and its residents with ill-advised changes to Medicare Part D and patent laws. Read the full post here.

U.S. officials warn medical devices are vulnerable to hacking: The federal government is warning about a medical device that could be tampered with by hackers. The FDA and Department of Homeland Security issued a statement that "strongly encourages" health care facilities to discontinue the use of Hospira's Symbiq infusion pump after officials learned the devices are vulnerable to cybersecurity threats. The medical device company confirmed that the computerized pumps -- which continuously deliver medication over an extended period -- could be accessed remotely through a hospital's network. This could allow an unauthorized user to control the device and change the dosage of medication the pump delivers to a patient. Read the full post here.

Allow medical devices sector to work with doctors: Pitching for allowing medical devices industry to engage doctors, industry body CII today said preventing medical practitioners to undergo training about latest technologies may be detrimental. Currently, under the voluntary the Universal Code for Pharmaceutical marketing Practices (UCPMP) industry is not allowed to engage medical practitioners for continued medical education on latest technologies, CII said in a statement. "Medical Device Industry is an innovation driven industry and needs to work with medical practitioners as well as paramedical professional in close proximity," the industry chamber said.  Read the full post here.

How can we derisk innovation in pediatric medical devices?: Sometimes, kids need intensive medical treatment – and the tools used for adults aren’t necessarily suitable to treat smaller, growing bodies. This presents a unique challenge for surgeons and clinicians, who find themselves with limited options when treating sick children. That’s where the Sheikh Zayed Institute for Pediatric Surgical Innovation comes in. It’s a division of the Washington, D.C.-based Children’s National Health System – and focuses on making pediatric surgery more precise, less invasive and, ideally, pain-free. Kolaleh Eskandanian, executive director of the Institute, spoke with MedCity News about the unique challenges in pediatric medical device innovation – and ways they’re helping jumpstart entrepreneurship in this small but important market. Read the full post here.

Technavio Says the High Demand for Biopharmaceuticals Will Inflate the Global Single-use Bioprocessing Systems Market Through 2019:  Technavio has published a new report on the global single-use bioprocessing systems market, which is expected to grow at a CAGR of more than 34% from 2015-2019. The new report indicates the increase in the aging population is leading to a rapid increase in patient population suffering from diseases such as diabetes, hypertension, musculoskeletal and cardiovascular diseases, chronic kidney diseases, cerebral strokes, and cancer. This increases the demand for biopharmaceuticals among patients. Read the full post here.

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This Week in BioPharma: 6/22-6/26

Here is the top news from the biopharmaceutical industry this week:

Organic Industry Wants Biotechnology Regulated By Process, Not Product: About 40 activist organizations that usually can be counted upon to rally with the organic industry against genetically engineered (GE) plants and animals weighed in with a letter to USDA’s Animal and Plant Health Inspection Service (APHIS) for the federal regulation of biotechnology products. Monday’s letter, which included some food company signatures as well as those from organizations, called for APHIS to “regulate biotechnology based process, not product.” The letter also called for adding noxious weeds to biotechnology regulations, which the signers want regulated to the “fullest extent.”

Saudi Engineer Invents Unique Biotechnology: Saudi engineer and inventor Ibrahim Alalim has 

come up with a new biotechnology to break down the composition of any animal fat, crude oil or any petrochemical product. “This biotechnology involves a liquid extract from vegetables that could be instrumental in coming up with products that will be useful in cleaning utensils, floors and marble,” Alalim said.

These are the Fortune 500's Fastest-Growing Pharma Companies: The pharmaceutical industry has been rocked in recent years by a confluence of patent expirations of blockbuster drugs, increasing competition from generics and new governmental and industry efforts to control costs the world over. That’s made growth prospects for many pharma companies a risky and uncertain proposition. 

The Importance of Real-World Data to the Pharma Industry: For years, randomized controlled trials (RCTs) were considered the gold standard for generating clinical data on efficacy and safety to support product registration and subsequent prescribing. Recently, analysts and academics have discussed the promise of real-world data (RWD), signalling its potential to contribute to improved health outcomes. Data's role in normal clinical practices, or in settings that reflect the reality of healthcare delivery, is likely to become increasingly important in ensuring that medicines are accepted by national policymakers and are adopted into practice.

Is the FDA Too Tough on Medical Device Makers?: In a new paper, “Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices,” Wharton health care management professors Matthew Grennan and Robert Town shed light on the question: Are the FDA’s medical device regulations too hard, too soft, or just right? Town recently sat down with Knowledge@Wharton to discuss their findings.

House Ignores Veto Threat and Backs Repeal of Medical Device Tax: The House on Thursday easily backed repeal of a tax on the medical device industry. But President Obama has threatened to veto the bill, which would add more than $24 billion to the deficit over the next 10 years. With not all House members voting Thursday, that chamber's 280-140 vote fell one vote shy of a veto-proof majority to repeal the tax, which helps pay for the expansion of health insurance under the 2010 Affordable Care Act.

Short Sellers Become More Focused on Big Pharma: The short interest data has been released for the June 15 settlement date. Pharmaceutical companies are usually involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside.

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This Week in BioPharma: 6/8-6/12

Top news from the biopharmaceutical industry this week:

In the future, treatments tailored to patients: Cambridge biotechs such as Genzyme Corp. and Alnylam Pharmaceuticals Inc. are developing personalized treatments for rare genetic disorders like Gaucher and Fabry disease. Vertex Pharmaceuticals Inc. of Boston is turning out a portfolio of medicines that attack the life-threatening lung disease cystic fibrosis by targeting specific genetic mutations.

Getting to the red zone in biopharma R&D: For some time after the FDA put its new breakthrough therapy designation together for the industry, there was a good deal of back and forth among industry analysts over whether the BTD would make much of a difference. You don't hear much of that kind of carping much these days, and a new report from EP Vantage illustrates why.

Study: biopharma innovation outpaces tech overall: Innovation in the biotech and pharmaceutical industries outpaced the combined activity of 12 technology sectors between 2009 and last year, according to a report released today by Thomson Reuters.

The 25 most influential people in biopharma in 2015: A lot of people make news in the biopharma business. Few of them are influential. Influence, simply put, is the ability to make your mark in such a way as to get other prominent people in this business to rethink the way they do business.

Alder Biopharmaceuticals' new drug promises migraine relief:  Shares of clinical-stage biopharmaceutical company Alder Biopharmaceuticals Inc. are up more than 100 percent from the lows they made in late April this year and are currently trading near their all-time highs.One of the main reasons for this surge has been the promising data released by company last month for its migraine treatment drug.

Cancer clinical trials expert to assist Regen BioPharma, Inc. in addressing FDA questions: The goals  of the collaboration is to  address  questions  posed by the FDA regarding  Regn BioPharma, Inc.'s planned  Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer and to modify the existing Investigational New Drug application in order to maximize the probability  of clinical trial success.

Merck Millipore develops compaction technology for biopharma: Merck Millipore, the life science business of Germany-based Merck, has developed a new technology that compacts dry powder cell culture media into granules, accelerating solubility and improving flowability and handling. The compacted media are, therefore, more convenient to use, allowing biopharmaceutical manufacturers to further optimize their upstream processes.

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Last Chance to Save Up To $550 off Immuno-Oncology

As research in cancer immunotherapies continues to rapidly evolve, it is critical to separate the real opportunities from the hype. There has been great progress with checkpoint inhibitors, CAR-T and T-Cell therapies, cancer vaccines, agnostic antibodies, and combination therapies.

IBC's Immuno-Oncology provides the critical insights and strategies you need to improve response rates, efficacy, and get closer to a cure!

Download the full agenda for complete session and speaker information here:

Immuno-Oncology

Advancing the Next Generation of Cancer Immunotherapies

September 30 – October 1, 2015

Hilton Alexandria Mark Center, Alexandria, VA

Visit the website for more details: http://bit.ly/1A4NPY2

Don't miss out on maximum savings for IBC's Immuno-Oncology!

Register by May 15 to Save up to $550 off the standard rates: http://bit.ly/1A4NPY2

Register today and explore the latest advances in Immuno-Oncology to:

-          Design next generation immunotherapies by understanding recent advances made with CAR-T and T-Cell therapies, checkpoint inhibitors, cancer vaccines, and agnostic antibodies

-          Develop a successful combination therapy strategy by gaining insights from global leaders on effective combinations

-          Improve the discovery and development of your promising immunotherapies by hearing best practices and lessons learned from the first wave of cancer immunotherapies

Best,

The Immuno-Oncology Team 2015

@ibcusa

facebook.com/ibclifesciences

www.ibclifesciences.com/ImmunoOncology

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