Top Scientists Address Downstream Processing

Characterization of Host-Cell Proteins Using Mass Spectrometry Enables Effective Purification Optimization

Lin Zang, Senior Scientist, Analytical Development, Biogen describes the mass spectrometry workflow for host cell protein identification that she will be presenting on at the BioProcess International Conference & Exposition, and discusses the implications of HCPs on downstream process development.

Hear more from Lin at 4:00 pm on Wednesday, October 28, 2015 at BPI.

Listen to her interview here: http://bit.ly/1VucXxR

A Novel Approach to Monitor Clearance of Host Cell Proteins Associated with Monoclonal Antibodies 

The big challenge in downstream process development concerning host cell proteins is that the amount of HCPs in the purified product is often so low that it is hard to determine the identity of the HCP. Min Zhu, Senior Scientist, Purification Process Sciences, MedImmune LLC, describes how the approach she will be presenting at the conference overcomes this challenge.

Hear more from Min at 4:30 pm on Wednesday, October 28, 2015 at BPI.

Listen to her interview here: http://bit.ly/1VucXxR

Implementing Multi-Attribute LC/MS Methods for More Informed Process Development 

Matthew Traylor, Analytical Scientist, Process Development, Shire, discusses how he gets a deep characterization a specific protein out of a mixture, using LC/MS software packages that automate the process. He shares how this technology can be used at laboratory, pilot and production scale process development.

Hear more from Matthew at 9:20 am on Tuesday, October 27, 2015 at BPI.

Listen to his interview here: http://bit.ly/1NKYZWY

Continued Process Verification (CPV) Informatics Systems and Validation 

Carly Cox, Senior Process Engineer, Pfizer, describes what a CPV informatics system is and how it’s used in product manufacturing. She’ll be presenting at the BioProcess International Conference on how multiple source systems can pull data on product manufacturing processing and be collected into a CPV informatics system, and some of the important areas to consider for validation and configuration for regulatory reporting and process monitoring.  

Hear more from Carly at 9:20 am on Wednesday, October 28, 2015 at BPI.

Listen Now: http://bit.ly/1IFdZ0I

Rapid Microbiological Methods for Real-Time Release of Autologous Cell Therapy Products 

Hear about how a risk based approach to autologous cell therapy products used at Vericel. In this podcast, John Duguid, Principal Scientist, Vericel Corporation, describes how rapid microbiological methods are used in product release of autologous cell therapy products, and discusses the areas of contamination risk. Audio Player

Hear more from John at 2:00 pm on Thursday, October 29, 2015 at BPI.

Listen to his interview here: http://bit.ly/1IFdZ0I

If you haven’t already, register for BPI 2015 taking place this fall in Boston. BPI is engineered to be exactly what YOU need it to be. Formal and informal networking experiences connect you to peers, prospects, and customers. Parallel tracks give you the option to dive deep or take a big picture approach to learn about industry trends, challenges, and benchmark against the latest research developments. Big pharma and large, mid-size and emerging biotechs collaborating with solution providers featuring proven and next generation technologies make BPI a one-of-a-kind meeting place.As a valued reader of our blog, you get an exclusive $100 off the current rate when you use code XB15171BLOG. Register here: http://bit.ly/1JA9EQe

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Overcoming the challenges of high concentration protein formulations

There is a trend within the biopharmaceutical industry for companies to develop formulations for protein drugs with extremely high concentrations. Such formulations provide advantages to both patients and clinicians as they allow biological drugs to be delivered via the sub-cutaneous route of administration rather than by the more traditional intravenous route. Sub-cutaneous delivery allows patients to receive treatment in a clinic or even administer the drug themselves while intravenous infusions tend to require the patient to make a hospital visit which increases the cost of treatment. However, if a patient is able to self-administer the pharmaceutical drug they require to treat a chronic disease then they are more able to lead a normal life which is a tremendous benefit (Highly concentrated protein formulations: Finding solutions for the next generation of parenteral biologics, J Kling, 2014).

The challenge of processing highly concentrated protein drugs

Being able to provide a biopharmaceutical at a formulated concentration of 100 g/L or higher can be a means by which biopharmaceutical companies can gain an advantage over one another in an increasingly competitive marketplace. However, developing such formulations is no trivial task because at high concentrations, protein solutions can become very viscous and difficult to process and the proteins themselves can aggregate. The viscosity of these solutions can challenge filtration equipment and can lead to significant yield losses in the final stages of the processes when the product has its greatest value. Protein aggregation can lead to a reduction in the pharmaceutical’s potency and can even trigger an immune reaction to the drug.

Innovation at the interface with formulations

The topic of high concentration protein formulations will be covered at the BioProcess International Conference & Exposition 2015 to be held on October 26-29 in Boston, MA. Sigma S Mostafa, PhD, Director, Process Development at KBI Biopharma Inc will be chairing a session on ‘Innovation at the Interface with Formulations’. Pfizer are scheduled to present on ‘Challenges of High Concentration Formulations – Dealing with Viscosity and Excipients’ while Mark Moody will present on ‘Opportunities and Challenges of High Concentration Biologics: Case Studies’. The session promises to address some of the key issues manufacturers face when processing concentrated protein solutions.

Have your say

Protein biopharmaceuticals are being formulated to 100 g/L even 200 g/L, however, some have proposed that concentrating to 500 g/L may be desirable. In your opinion, what is the maximum concentration that is required or attainable for protein drug formulations?

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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Single-Use Standardization on the agenda for BPSA at BPI Boston, 2015

“The BioProcess International Conference has always been a good venue for the Bio-Process Systems Alliance to work with industry to identify issues and define next steps”, say Todd Kapp, BPSA Board Member and Sales & Market Development Manager of Parker domnick hunter – North America.

The Bio-Process Systems Alliance is a leading trade association which facilitates the implementation of single-use bioprocessing through networking opportunities, creating a safe harbour for dialogue between industry and business leaders, providing forums for end-users and suppliers to work together and producing best practice guides.

“The BPSA has become a recognized leader in the industry for bringing users and suppliers of single-use technology together to discuss and educate one another on best practices and guidelines for implementation”, Kapp observes.

Single-Use Standardization

Along with other industry organizations such BPOG, PDA, ASTM and ASME BPE they will be participating in a Town Hall Forum Discussion on Single-Use Standardization at the BioProcess International Conference andExposition 2015 in Boston.

Standardization of single-use assemblies is an objective for many biomanufacturing organizations as they seek to reduce inventories and working capital. Historically, standardization exercises within the processing industries have been somewhat protracted affairs as various players try and agree on the preferred solution to standardize upon.

Todd Kapp (Parker domnick hunter & BPSA Board Member) 

EPICSolutions™ for Single-Use Technologies

Successfully implementing single-use technologies into biomanufacturing processes raises a number of issues that end-users are having wrestle with including the safety of the materials used, whether they shed particles or can maintain integrity and an increased reliance on the quality systems of their suppliers including their change notification procedures.

To help end-users address these issues the BPSA will be leading or contributing to sessions along the theme of EPICSolutions™ which stands for Extractables, Particles, Integrity, Change and Sustainability and was the main theme of the BPSA Summit held in Washington DC last week.

Kapp explains, “BPI has been and continues to be a great way for BPSA to communicate with the market and spread the word about the value it brings to industry”.

Without doubt BPI will be a richer learning experience for bioprocess engineers on their journey to implement single-use technologies by the inclusion of the BPSA in the program.

Dr Nick Hutchinson

nick.hutchinson@parker.com

Join me at #BPIconf

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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The continuous production of biopharmaceutical drugs

If there is one hot topic in biomanufacturing at this moment in time it has to be continuous processing. Journals and websites are feeding, what appears to be, the biopharmaceutical industry’s almost insatiable appetite for information on the subject. The interest is reflected in the deals made within the industry such as Pall Corporation's acquisition of the BioSMB technology platform from Tarpon Biosystems and Repligen Corporation’s 2014 acquisition of Refine Technology. Refine developed and manufactured the Alternating Tangential Flow (ATF) filtration device which can be used to retain mammalian cells within bioreactors while continuously harvesting product.

With such a focus within biopharma upon continuous processing it is no surprise that a significant portion of the Bioprocess International 2015 Conference, agenda is allocated to talks on this subject. Before we look at some of those talks in more detail, however, we should review the industry drivers that appear to be taking the bioprocess sector away from the batch process paradigm and moving it towards a continuous manufacturing future.

The four key industry drivers behind continuous bioprocessing

In an excellent article, Veena Warikoo from Genzyme, a Sanofi company, and co-workers published in 2012 on the “Integrated Continuous Production of Recombinant Therapeutic Proteins” (Biotech Bioeng, 2012;109: 3018-3029). Four key drivers are given as:

1.    the need for biopharma companies to flexibly accommodate large-volume and orphan drugs potentially within the same facility

2.    the need for production platforms to accommodate both stable monoclonal antibody and less stable recombinant protein therapeutics

3.    the need to make rapid adjustments in production capacity in line with the dynamics of market demand

4.    increasing cost pressures, not least, due to the growing pipeline of biosimilars in development

The benefits of bioprocess intensification

Warikoo and her co-authors explain that the conversion for batch to continuous manufacturing has occurred in many other industries in the past and has led to the following benefits:

1.    steady-state operation

2.    small equipment size

3.    high volumetric productivity

4.    streamlined process flows

5.    low cycle times

6.    reduced capital costs

Too conservative for continuous?

Bioproduction is renowned for being a conservative endeavour. Despite the business deals and industry drivers are we really ready for continuous biomanufacturing or is the noise in the media simply empty hyperbole? Will continuous processing become the rule or remain the exception? Join the debate by letting us know your thoughts.

 

Dr Nick Hutchinson

Join me at #BPIconf

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

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Best,

The Immuno-Oncology Team

@ibcusa

Futurebiopharma.blogspot.com

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