2015

Cell-line/Process Development – BPI Theater @ BIO 2015

Ray Price (senior director of business development, DiscoveRx) 3:30–3:55 pm Advances in Research Tools to Accelerate Drug Development Price introduced the BioSeek drug-discovery platform with examples. The technology is built on three pillars: primary human cells; models that use growth factors or cytokines to model a disease environment and then predict how drugs change biomarker responses in those systems; and comparisons of generated profiles with a reference database of more than 4,000 compounds. DiscoveRx uses that database and informatics tools…

Managing Contract Relationships: A BPI Theater Roundtable at the 2015 BIO Convention

On Wednesday 17 June 2015, Patricia Seymour (senior consultant at BioProcess Technology Consultants) chaired a midday roundtable titled, “Managing the Contract Relationship.” She brought together a panel of four experts with different perspectives (contract manufacturing, cell and protein therapies, and legal negotiations): Koen Hellendoorn (head of sales and customer account management at FujiFilm DioSynth Biotechnologies) Justin Skoble (senior director of technical operations for Aduro Biotech) Tom Douville (director of biopharmaceutical development at Kolltan Pharmaceuticals) Lily Vakili (senior counsel of Faber,…

Speeding Development and Lowering Costs While Enhancing Quality: A BPI Theater Roundtable at the 2015 BIO Convention

On Tuesday, 16 June 2015, Thomas C. Ransohoff (vice president of BioProcess Technology Consultants) chaired a midday roundtable titled, “Stretching for the Trifecta: Innovative Strategies for Speeding Development, Lowering Costs, and Enhancing Quality.” He brought together a panel of four industry experts: Joanne Beck (senior vice president of process development at Shire Pharmaceuticals) Parrish Galliher (chief technology officer for upstream (Xcellerex) at GE Healthcare) Lynne Frick (director of continuous processing for the Americas at Pall Corporation) Mark Brower (senior research…

The Contractor Perspective: A BPI Theater Roundtable at the 2015 BIO Convention

On Thursday, 18 June 2015, Gil Roth (founder and president of the Pharma & Biopharma Outsourcing Association, PBOA) chaired a midday roundtable titled, “CDMO Challenges and Opportunities.” He brought together a panel of four industry experts: Thomas Thorpe (chief executive officer of Afton Scientific) Michael Riley (vice president and general manager of Catalent Biologics) Victor Vinci (vice president and chief scientific officer for Cook Pharmica) Amit Arora (chief marketing officer at Jubilant HollisterStier) Points of View The Pharma and Biopharma…

Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow–Fill–Seal Plastic Vials

PREPRINT October 2015 issue Blow–fill–seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1–3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the pharmaceutical industry for decades, primarily in the respiratory and topical ophthalmic markets. Such product formulations range from simple solutions to emulsions with drug substances from classical small molecules to large complex proteins such as biologics. The company also has optimized BFS processes and its Advasept plastic container system for…

Secondary Packaging: Creating Value with Product Lifecycle Management

with Daniela Guttmann and Susanne Hall Increasing regulatory requirements combined with the market pressure to develop patient-friendly drug delivery systems make product lifecycle management (PLM) a decisive field for today’s pharmaceutical and biotechnology companies. Their strategic service providers also are affected by those conditions. For example, as an internationally operating contract development and manufacturing organization (CDMO), Vetter reports an increasing number of life-cycle management projects with its customers in the past years. Learn more in this white paper from Vetter.…

From the Editor

More often than we realize, industry literature suffers from discrepancies in definitions of (seemingly) common, basic terms. We have pointed this out before — twice addressing the differences between analytical and bioanalytical testing, for example, and cautioning against misunderstanding the distinctions. Some terms are interchangeable, though, or it may be too soon to separate them from one another (e.g., cell therapies and therapeutic vaccines). We editors accept much of this as normal. Differences in interpretation will persist, and often a…

Spotlight

BioProcess Development Week 2015 by Maribel Rios From 30 March to 2 April 2015, more than 750 professionals gathered at the Hyatt Regency Resort in Huntington Beach, CA, to attend the annual Biopharmaceutical Development and Production meeting. Organized by IBC Life Sciences, BDP Week provided attendees with keynote addresses and sessions on the state of the bioprocessing industry and hot technical topics as well as preconference workshops, exhibit hall networking opportunities, poster presentations, and keynote addresses from five bioindustry leaders.…

Are You Ready for a Tech Transfer? Part 2: Overcoming Obstacles and Implementing Best Practices for Cell Therapy Technology Transfer

In part 1 of this two-part series, we outlined common challenges of technology transfer that are unique to the cell therapy industry and discussed strategies for success (1). Here, we delve even further into best practices and highlight key strategies for technology transfer that should be considered along the path to success. Creating a strong foundation for technology transfer will streamline clinical manufacturing processes and help position therapeutic products for long-term success. Below are key criteria for success. Confirm Transfer…

Challenges in Implementing Quality By Design: An Industry Perspective

In the fall of 2004, the US Food and Drug Administration (FDA) published a final report entitled Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (1). This publication set the groundwork for a prospective risk‑based approach to pharmaceutical product development. It was published on the heels of a November 2003 agreement between the FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to develop an internationally harmonized plan for developing…