Posted by Al Doig | Under Process validation, Quality risk management
Wednesday Dec 7, 2016
Posted by Al Doig | Under Conference announcement, Manufacturing capacity, Modeling
Tuesday Dec 6, 2016
Our article entitled: “Biopharmaceutical Manufacturing Process Validation and Quality Risk Management”, authored by Francisco C. Castello, Ph.D., Brendan Cooney and Howard L. Levine, Ph.D. of BioProcess Technology Consultants, has been chosen as a top five contribution by ISBE for 2016. The article appeared in the May/June 2016 edition of Pharmaceutical Engineering® Magazine. The piece describes process validation today as a continual, risk-based, quality-focused exercise that encompasses the entire product life cycle. If you are an ISPE member, we at BPTC hope you will consider our article when voting for the 2016 best paper award.
Pharmaceutical Engineering has established an “Article of the Year” award to recognize the contribution of authors. Articles are evaluated by a panel of volunteer reviewers according to a number of criteria, concentrating on the importance and timeliness of the subject matter and the quality of the presentation.
Posted by Al Doig | Under Biopharmaceuticals, Cell/gene therapies, Conference announcement
Tuesday Oct 25, 2016
At the upcoming BioProcess International West Conference (Feb 27-Mar 2, 2017, San Francisco), Tom Ransohoff, Vice President and Principal Consultant at BioProcess Technology Consultants, will present a paper entitled “Challenges in Forecasting Biopharmaceutical Demand and the Value of Flexibility.” In this talk, Mr. Ransohoff will review the sources of uncertainty in forecasting demand for biopharmaceutical capacity and will describe how this uncertainty is linked to the value of flexibility in manufacturing facilities and strategy.
Posted by Al Doig | Under Antibody drug conjugates, Biopharmaceuticals, Breakthrough therapy, Cell/gene therapies, Early-stage development, Outsourcing, Supply chain
Monday Sep 26, 2016
Frank Riske, Ph.D., Senior Consultant at BioProcess Technology Consultants will be delivering the Keynote Address entitled: Biopharmaceuticals: Past, Present & Future at the 8th Annual PEGS Europe Conference in Lisbon, Portugal. His presentation will cover the evolution of bioprocessing starting with the production of molecules such as insulin, HGH and alpha-interferon and bringing us up to today; a market dominated by monoclonal antibodies but where gene and cell therapy have become increasingly commonplace, biogenerics have made their mark and a number of new therapies are in the works.
Posted by Al Doig | Under Biopharmaceuticals, Process development, Quality by design, Regulatory
Wednesday Aug 10, 2016
Innovative cell and gene therapies and the resurgent interest in ADC’s (antibody drug conjugates) are emerging therapies that are creating these challenges. The roundtable discussion entitled; Outsourcing and Biomanufacturing Challenges for Emerging Therapies, at BIO 2016 focused on demands for CMO services associated with these therapies. Patti Seymour, Senior Consultant at BPTC moderated a panel consisting of Mark Angelino, bluebird bio; Chris Chen, WuXi Biologics; and Andreas Weiler, Lonza: three respected industrial strategic outsourcing thought leaders.
Topics addressed by the panel included forecasting the demand for CMO services and the associated issue of capacity planning. Within this context are the concerns about process design and control as well as regulatory framework related issues such as batch definition when evaluating centralized versus decentralized models for cell therapy. Another discussion point addressed the complexities of supply chain when managing four or more CMC programs per ADC product.
One approach to services planning suggested by the panel begins by sorting the preclinical and clinical pipelines in these therapeutic areas and identifying the short and long term technology implications and capacity needs. Everyone agreed these emerging therapies will represent a learning curve for CMO’s and embody a step-up in risk for both innovators and CMOs.
However, the panel agreed that allogeneic and autologous cell therapies, gene therapies with their associated viral vectors and delivery modes, and novel antibody-linker-toxin ADC combinations represent potent disease therapy options and have the potential to cure disease. These therapies are gaining traction and have great promise. BPTC has a number of client projects in all three areas and is witnessing rapid innovation within these emerging therapies.
by: Brendan Cooney
As the biopharmaceutical manufacturing industry grows and becomes global, companies face demands to improve quality, while reducing costs and increasing output. The road to achieving these goals is through the adoption of QbD. A paradigm shift, when adopted by the FDA in 2004, QbD is modernizing the approach to pharmaceutical development by providing the industry with regulatory flexibility, increased development and manufacturing efficiency, and providing opportunities for innovation.
A recent article authored by BPTC consultant Brendan Cooney entitled; “Quality by Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development”, describes the current best practices concerning the implementation of QbD in the manufacture of monoclonal antibodies. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials impacts the final product. Historically, product quality has been assured by either end product testing (drugs) or by strict and narrow control of the manufacturing process without a comprehensive understanding of the link between process parameters and product quality attributes (biologics). When QbD is properly implemented, quality is built into the process rather than being tested into the product, allowing for incremental process changes to be made within defined ranges without needing prior regulatory approval.
BPTC’s 2nd edition of “The Development of Therapeutic Monoclonal Antibody Products”, due to publish in September 2016, provides extensive coverage of QbD as applied through the CMC development cycle. This report provides a roadmap covering strategy, technical and regulatory requirements for the development of a monoclonal antibody product from initial discovery through the filing for first in human clinical trials.