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cGMP Manufacturing at 1000L scale

Events Calendar

Next Event

7th July, 2016
KTN Biopharmaceutical Formulation Group, London
The KTN's Biopharmaceutical Formulation Group hosted by the EPSRC Centre for Innovative Manufacturing at UCL.

The event is an opportunity to hear from industry and academia in the areas of high throughput formulation screening approaches and strategies, alongside improving formulations with novel delivery modes and excipients.


The KTN's Advisory panel for this meeting includes representation from UCL, Medimmune, FUJIFILM Diosynth Biotechnologies, GSK, Arecor and Novaliq.


7th July, 2016

KTN Biopharmaceutical Formulation Group, London

The KTN's Biopharmaceutical Formulation Group hosted by the EPSRC Centre for Innovative Manufacturing at UCL.

The event is an opportunity to hear from industry and academia in the areas of high throughput formulation screening approaches and strategies, alongside improving formulations with novel delivery modes and excipients.


The KTN's Advisory panel for this meeting includes representation from UCL, Medimmune, FUJIFILM Diosynth Biotechnologies, GSK, Arecor and Novaliq.


16 August 2016

Webinar: Differential Scanning Calorimetry Applications

Join Malvern presents, Webinar: The Power of Heat: Digging Deeper with Differential Scanning Calorimetry to Study Key Protein Characteristics by, Katherine Bowers, Ph.D., Formulation and Analytical Development Scientist, FUJIFILM Diosynth Biotechnologies

Register Now
Tuesday, August 16th at 10:30-11:30 EST

Differential Scanning Calorimetry (DSC) has a long history of playing a vital role in biopharmaceutical development. From candidate selection, formulation development, stability monitoring and bio-similarity assessment, DSC still remains one of the top assays utilized in the pharmaceutical industry during the development and approval of protein-based therapeutics. There is familiarity in the biopharmaceutical industry with the basic concept of DSC as it relates to protein stability.

In this presentation, real-life examples of taking DSC analysis deeper will be presented. These examples will include monitoring the binding of a metal ion to an enzyme, high(er) throughput formulation development using a DOE approach for a monoclonal antibody and using DSC to assist in the development of a complex purification process for a fusion protein.


22-23, September 2016

Contracting & Outsourcing Conference


4-7 October, 2016

BioProcess International Conference & Exposition


10-13 October 2016

World ADC, San Diego


1-2 November, 2016

Outsourced Pharma - San Francisco


14-16 November, 2016

European Antibody Congress


PRESENTATION: Flexible High-Containment Vaccine Manufacturing

Dr. Thomas Page, VP. of Engineering at FUJIFILM Diosynth Biotechnologies, Texas site presented "Flexible High-Containment Vaccine Manufacturing" at the World Vaccines Congress this past March. This presentation focused on:

Fujifilm Diosynth delivers on the mission of innovation
Bringing the new generation design of MCR Systems
Innovating in control of multiproduct, high containment manufacturing
Rooms as equipment: Deliver optimized custom environment for each product's unique requirements

http://www.slideshare.net/fujifilmdiosynth/tcp-wvc2016-presenation-61121166


20 October, 2015

WEBINAR: Quantifying Stability and Determining Aggregation Pathways for Biologics Presented by Unchained Labs

Identifying conditions that maximize the structural stability of a biologics native state is essential for developing therapeutics, formulations, and process development conditions. In this GEN webinar our panelists will present methods and results using chemical denaturation as a way to determine the Gibbs free energy (ΔG) of proteins in a given formulation. The HUNK, a fully automated chemical denaturation platform, provides quantitative data on protein stability, allowing researchers to rank protein constructs, screen and optimize formulations, and assess the propensity for denaturation and aggregation. Traditionally, aggregation is measured over long periods of time using size exclusion chromatography. By increasing protein concentration and measuring the change in ΔG (ΔGtrend), the HUNK can measure aggregation immediately and distinguish native from denatured state aggregation.

Our first presentation will be given by Joe Barco, Ph.D., Senior Product Manager at Unchained Labs. Dr. Barco will provide a brief introduction to the HUNK, a fully automated chemical denaturation platform.

The second presentation will be provided by Katherine Bowers, Ph.D., Principal Scientist at Fujifilm Diosynth Biotechnologies. Dr. Bowers will present chemical denaturation data and its application to stability determination for protein comparability, formulation optimization and downstream process development.

Who Should Attend
◾ Researchers interested in avoiding protein aggregations
◾ Scientists involved in biophysical protein characterizations
◾ Researchers interested in protein stability
◾ Scientists involved in formulation screening and optimization

You Will Learn
◾ The use of chemical denaturation for measuring biologic stability (ΔG).
◾ The application of the HUNK platform for routine determination of stability (ΔG) in different formulations and for protein comparability.
◾ How to immediately determine protein aggregation states (ΔGtrend).

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.

REGISTER NOW, Click link below.

http://www.genengnews.com/webinars/quantifying-stability-and-determining-aggregation-pathways-for/266/?kwrd=fujifilm


Webinar : Process Development studies for Product Commercialisation

Webinar led by Dr Graham McCreath (Head of Process Design); Dr Mahesh Shivhare (Senior Process Statistician) and Dr. Simon Hanslip (Senior Technical Project Leader). The webinar discusses activities for successful Process Characterisation and Process Validation.

http://www.business-review-webinars.com/webinar/Pharma/Process_Development_studies_for_Product_Commercialisation-GQJyqZmT?utm_source=SP&utm_medium=IU&utm_campaign=FJ1


WEBINAR: Tools for Achieving Robust Process Design with Early Phase Process Development

The webinar will provide a case study and discuss how to rapidly develop customized, reliable manufacturing processes. The keys to developing biomanufacturing processes which are efficient, robust and of high quality start during the initial design stages of cell line and process development.

http://xtalks.com/process-design-early-phase-process-development.ashx


Webinar : From Gene to Manufacturing

The keys to developing biomanufacturing processes - which are efficient, robust and of high quality - start during cell line and process development and initial process design. Join us for this complimentary webinar, hosted by Dr Alison Porter, Head of Mammalian Cell Culture R&D, and Dr Stewart McNaull, Director, Development & Technical Services, discuss how FUJIFILM Diosynth Biotechnologies' cell line development and upstream process development platforms have been modified and optimized to develop customized, reliable manufacturing processes. This includes the introduction of our new mammalian expression platform, called Apollo(TM).

http://xtalks.com/Cell-Line-Development.ashx


Webinar : The Single-use Technology Paradigm

Dr Stewart McNaull presents a webinar entitled 'The Single-use Technology Paradigm' as part of Business Review Webinars' Knowledge Sharing series.

http://www.business-review-webinars.com/webinar/Pharma/The_Singleuse_Technology_Paradigm-BQCgqW7V


Webinar : Automating final filtration & dispensing of biologics in a closed single-use system

Dr Paul Bird, Head of Manufacturing Engineering, co-presented a case study in this webinar with Parker Domnick Hunter on 25th June 2014.

http://www.business-review-webinars.com/webinar/Pharma/Successful_Implementation_of_Automation_in_SingleUse_Bioprocessing-dJxn4CZj



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