Author Archives: BPI Staff

Blockbuster 2.0: Who’s Ready?

During a BPI Theater @ BIO presentation on Wednesday, 5 June 2019, Charles Christy, director of commercial development at Ibex Solutions (Lonza Pharma and Biotech), considered the increasing speed of molecule discovery, process development, and clinical approval in the biopharmaceuticals industry. Weighing the promises and pitfalls of such a volatile, uncertain market, Christy offered drug developers advice about when to build biomanufacturing facilities in-house and when to outsource services. One solution, Christy suggests, is to partner with agile contract development…

Quality Considerations for Introducing New Products into Your Facility

Ray Marzouk, vice president of quality at Avid Bioservices, joined the BPI Theater at BIO on Wednesday, 5 June 2019, to call out factors that drug developers often neglect when they are deciding whether to enlist a contract development manufacturing organization (CDMO) for scaling up and introducing new therapies in a competitive market. Citing examples related to ICH Q5d cell banking rules, Marzouk explained how Avid conducts smooth and rapid transfers of key process elements and quality diagnostics. Streamlining that…

Next Generation Manufacturing for Biopharmaceuticals

In this BPI Theater @ BIO presentation from Tuesday, 4 June 2019, Thomas Page, a vice president of engineering and asset development, explains how Fujifilm Diosynth partners with other organizations to deliver commercial-quality chemistry, manufacturing, and controls (CMC) for complex, next-generation biopharmaceuticals. Rather than simply transacting with clients, Page notes, his firm elects to go beyond standard engineering controls for patient safety and clinical filing. Using a wider array of risk assessments than is typical in the industry enables Fujifilm…

The Cocoon Platform: A Kaleidoscope Approach to Cell Therapy Manufacturing

Matthew Hewitt, the head of clinical development at Lonza’s Walkersville headquarters, unveiled the company’s Cocoon platform at the BPI Theater @ BIO on Tuesday, 4 June 2019. Scalable, fully closed, single-use–capable, and intuitively interfaced, the platform offers what Hewitt terms a kaleidoscope approach to cell therapy manufacturing because it enables drug developers increased ability to customize their processes. The technology also addresses many pain points specific to the cost of cleanroom space, labor, and scalability. These exciting features, Hewitt concludes,…

Cell Line Development Strategies for Difficult-to-Express Proteins

Steven Hager, a senior director of technical support, joined the BPI Theater at BIO on 5 June 2019 to describe how Catalent Biologics’s emerging cell-line engineering technologies can aid in developing therapies based on difficult-to-express proteins. Hager presented two case studies to this end, the first involving insertion of a tag into an antibody for conjugation with a toxin to create an antibody–drug conjugate (ADC), and the second showing another antibody with two sites for conjugation on each chain. Using…

Qualification of Single-Use Sensors for Batch and Continuous Processes

In this 5 June 2019 presentation at the BPI Theater at BIO, Jim Furey contended that the term Industry 4.0 is actually about developing robust sensor systems. A general manager at PendoTECH, Furey recounted experiences with biomanufacturers who chronically reported single-use sensor failures due to intense processing requirements. Even if a process does not involve harsh solvents, Furey points out, several preparation steps can pose problems for single-use sensor systems. Using these experiences, Furey makes the case for more carefully…

A Road Map to Licensure of MAb Manufacturing: Implementing Multicolumn Capture Chromatography

Lilon Huang, a principal engineer of manufacturing operations, delivered a BPI Theater presentation at the BIO International Convention on Wednesday, 5 June 2019, to detail Emergent BioSolution’s efforts to enter the continuous processing arena, specifically the use of multicolumn chromatography. While the move to this technology was designed to reduce costs, Huang explains, it has also created opportunities to partner with industrial leaders in ways that afford crucial feedback for drug design and development. Fill out the form below to…

Commercialization Frameworks for the Biopharma Ecosystem

Although there’s no shortage of information on data processes, many drug companies neglect to ask fundamental questions that should drive their commercialization strategies. In this CPhI Theater presentation, delivered on 4 June 2019, Kiran Chin (managing partner and chief executive officer at MKA Insights) brought these questions to the fore of the discussion. Drug developers, Chin contended, need to do a better job of asking: Why do we exist? What are our capabilities? What technology do we feel is our…

Industry’s Uptake of Single-Use Technology and How it Has Driven Vendor Consolidation: A Business Journalist’s Point of View

BioProcess Insider Editor, Dan Stanton, took a look at a decade of single-use, exploring the biopharmaceutical industry’s uptake of single-use technologies and placing it in context with the forecasting conundrum. Twenty years ago the demand for cell culture volume capacity exceeded the supply that was available, which played a large role in generating investment into capacity over the next several decades. Stanton provided examples of companies who invested money into expanding their facilities to meet increased capacity.

Boehringer to buy cancer vaccine firm AMAL for €325m

The acquisition will be the latest boost for Boehringer Ingelheim in the immune cell-directed therapy space, adding a fusion protein platform and a colorectal cancer vaccine candidate. AMAL’s lead candidate is ATP128, a vaccine in development for stage IV colorectal cancer. The candidate, set to enter the clinic this month, is based on AMAL Therapeutic’s KISIMA technology platform, which brings together three components into a fusion protein used as a vaccine. These are a cell-penetrating peptide for antigen delivery, a…