Author Archives: BPI Contributor

Efficient Technology Transfer: A CDMO Perspective

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This webcast features: Roy Sevilla, Senior Manager, Process Development Upstream Group, Avid Bioservices Successful technology transfer is essential to enable rapid manufacturing of biopharmaceuticals for early and late phase clinical supply. When a customer approaches Avid Bioservices to transfer an existing production process, we approach the technology transfer in a structured way involving a cross-functional team from all key functions of the company. This helps ensure the ability to understand and execute against the project requirements, mitigate risks, deliver the…

July 8, 2019

Immunotherapy: Taking Aim at Solid Cancers

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As cell and gene therapies arrive on the market, all eyes have focused on autologous chimeric antigen receptor (CAR) T – cell therapies. At the 2019 Phacilitate Leaders World and Stem Cell Summit in Miami, FL, delegates looked at where the biopharmaceutical industry is going in the cellular immunotherapy space. Whether for off-the-shelf CAR T-cell products, personalized cancer vaccines, or modified natural killer (NK) cells derived from human induced pluripotent stem cells (iPSCs) — cell and gene therapy development is…

June 28, 2019

Supply Chain Solutions for Cell and Gene Therapy Companies

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Stakeholders across the supply chain stress that quality of starting material will be key to the success of cell and gene therapies. This is a topic that has created issues in the past, is puzzling the industry presently, and is likely to cause more problems going forward. This topic was front and center at the 2019 Phacilitate Leaders World and World Stem Cell Summit in Miami FL, with presentations focusing on supply chain solutions to address these complex challenges; cell…

June 28, 2019

Automation in Cell and Gene Therapy Development

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The US approvals of chimeric antigen receptor (CAR) T-Cell therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) and gene therapy Luxturna (voretigene neparvovec) in 2017 heralded a “new frontier of medicine.†But with great innovation comes great costs and criticism (such as the Kymriah’s US$475,000 price tag). Many companies argue that these one-off therapies represent good value for patients and payers compared with traditional treatments, however, no matter your perspective, the COGs picture for cell and gene therapies isn’t good and…

June 28, 2019

Manufacturing of Cell and Gene Therapies

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The peak of demand for curative cell and gene therapies will be unlike that of traditional drugs and thus could cause forecasting and overcapacity issues going forward. Predicting the future is always difficult, and poor decisions can be costly and highly damaging for a company. At the 2019 Phacilitate Leaders World and Stem Cell Summit in Miami, FL, several presentations and conversations focused on the forecasting dilemma and how manufacturing needs innovation, just to name two. This eBook details these…

June 28, 2019

Lenti Non-Settled Suspension Harvest Clarification Process Development

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This webcast features: Stephen Tottey, PhD, Associate Principal Scientist, Process and Technology Development, Wuxi Advanced Therapies and John Taylor, Process Development Scientist, MilliporeSigma. Clarification of non-settled Lenti suspension harvest can be challenging due to high level of impurities in the feed stream, physical characteristics of the vector, limited filter choices, and low recovery. A series of clarification studies led to the identification of two feasible clarification filter set up options that provide workable outcomes regarding product recovery, impurity reduction, process…

June 20, 2019

Single-Use Systems: Globalization Best Practices and Technology Specifications

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The challenges of multi-national bioprocessing operations are numerous. They include finding highly skilled experts for each site, lack of expertise with single-use systems, contamination risks and redundant efforts and resources—all of which can lead to higher costs. But these challenges also present opportunities for increasing speed to market, eliminating redundant work and overall cost savings. This white paper details the best practices used in global drug manufacturing. The key is global coordination. Best practices and specifications need to be identified…

June 19, 2019

Long RNA Synthesis Report

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Long single-stranded RNA oligonucleotides are increasingly necessary for a variety of genomic pathway research and drug discovery studies. However synthesizing and purifying long RNAs can pose unique challenges due to their sequence composition, secondary structure, and applied modifications. Here we explore how Horizon Discovery is leveraging Dharmacon’s 20+ years of RNA synthesis experience to solve the challenges of long RNA oligo synthesis to address unmet research needs.

June 19, 2019

Product Robustness, Integrity Testing Science and Technologies for Enhanced Process Integrity and Patient Safety

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This webcast features: Carole Langlois, Marketing Manager, Traditional Vaccines, and Marc Hogreve, Senior Engineer Integrity Testing, at Sartorius Stedim Biotech With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies. The presenters…

June 14, 2019
MYCAP CCX flask cap

Transform Cell Expansion: Expand Outside the Hood

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This webcast features: Charles Meadows, Head of Product Management, Smart Consumables, Sartorius-Stedim Biotech Cell Culture expansion from vial to seed bioreactor is done by passaging culture through successively larger Erlenmeyer shake flasks. Sampling, media feed, inoculation and transfers are done non-aseptically by unscrewing the cap in a biosafety cabinet (BSC). Contaminated expansions due to non-aseptic technique are abandoned costing time and materials. Sartorius leveraged novel bottle closure manufacturing technology to create MYCAP® CCX. MYCAP® CCX combines tubing for aseptic fluid…

June 13, 2019