Author Archives: BPI Staff

PBL 3,000L Plant Could Alleviate Erwinaze Shortage

Porton Biopharma Limited (PBL) has opened a facility in Wiltshire, UK to make cancer drug Erwinaze (asparaginase Erwinia chrysanthemi). PBL is a biomanufacturer owned by the UK Government. Construction of the 2,100 m2 facility began in May 2016, through a multi-million pound investment from the UK’s Department of Health Capital funding. The plant has opened its doors and full production is set to commence over the next 12 months once the process of qualifying and validating the equipment is complete.…

BioProcess International Announces the Launching of BioProcess Insider ― Business News and Analysis for the Biopharmaceutical Industry

Launching in June 2018, BioProcess Insider, a digital information portal will deliver the latest financial and business news and expert insider views impacting the research, development, and manufacturing of biologics directly to your inbox including global markets, deal-making, facilities and capacities, upstream and downstream processing, therapeutic classes, and international regulations. BioProcess International (BPI), the biopharmaceutical industry’s leading business-to-business information platform, announced the June 2018 launch of BioProcess Insider, a digitally delivered news and analysis platform dedicated to providing biopharmaceutical manufacturers,…

April Spotlight

Looking Back, Looking Ahead Check both ways before proceeding — always good advice. Industry analysts at GlobalData and Mergermarket (an Acuris company) have reviewed 2017 and made predictions for the biopharmaceutical industry in 2018. Set against a backdrop of remarkable advances in technology and the growing relevance of biosimilars, last year was marked by both disappointments and noteworthy innovations. GlobalData points to major regulatory approvals in “nearly every major therapeutic area.” These include CAR T-cell oncology treatments, the first biologic…

March Spotlight

Welcome New Editorial Advisor Kavita Ramalingam Iyer is associate director and product lead of GRACS-CMC for vaccines at Merck Sharp & Dohme Corp. She received her PhD in biotechnology from Anna University (India) and completed a postdoctoral fellowship at the University of Minnesota (focusing on antibody engineering and synthetic biology) before joining Merck in 2008. Kavita has over 10 years of pharmaceutical industry experience leading chemistry, manufacturing, and controls (CMC) development; manufacturing; establishment of good manufacturing practice (GMP) facilities; technology…

Spotlight for January-February

Tracking Antibodies in the Clinic In tracking clinical trial activity around the world, GlobalData has identified 5,273 clinical trials of monoclonal antibodies (MAbs) that started between 1 January 2007 and 31 December 2016. The top three drugs in numbers of trials were bevacizumab, adalimumab, and tocilizumab. Rounding out the top 10 were rituximab, nivolumab, pembrolizumab, ranibizumab, secukinumab, trastuzumab, and ipilimumab. Healthcare analyst Marco Borria said, “All the top 10 drugs are marketed, and the majority of trials initiated for them…

Jonathan Royce and Brian Caine

A Discussion Regarding the Productivity in Downstream Operations

At the Biotech Week Boston conference (24–28 September 2017), BioProcess International publisher Brian Caine had the opportunity to speak with Jonathan Royce, global business leader for chromatography resins at GE Healthcare. Their discussion covered current downstream challenges and the company’s next-generation chromatography resin. Industry Challenges Caine: What are the most critical purification challenges for biomanufacturers? Royce: The bioindustry has seen more than a 100-fold increase in the productivity of cells. This means that downstream purification technology must continue to evolve…

December Spotlight

Revealed: Where Scientists Want to Work When you’re in the business of life-science innovation, highly trained employees are worth every penny. That’s why biotechnology companies pay top dollar for amenities-rich locations and facilities in the top US life-science real estate markets, according to Jones Lang LaSalle’s (JLL’s) Life Sciences Outlook published this past summer. JLL is a professional services firm that specializes in real estate and investment management. Its report says that life-science professionals have high expectations for their workplaces.…

November Spotlight

Crowdsourcing Cancer Research and Biomanufacturing In June, BioMed X launched two new global calls for application together with Merck KGaA for RNA splicing in cancer and for engineering of high-performance production cell lines. Talented young scientists from top universities and research institutions were invited to submit innovative project proposals and apply for a research fellowship at the BioMed X Innovation Center in Heidelberg, Germany. BioMed X was founded in 2013 in collaboration with Merck, its first pharmaceutical partner. Since then,…

October Spotlight

Introducing New Editorial Advisor Dr. Sanjay Nilapwar works as a purification process scientist in the novel-molecules group of Medimmune in Gaithersburg, MD, where he is also part of the platform chemistry, manufacturing, and controls (CMC) development team for antibody–drug conjugate products. In this position, he looks after the transitioning of ADC and monoclonal antibody (MAb) molecules as candidate drugs from development to the manufacturing stage, which encompasses cycles 1 and 2 purification process development, technology transfer and related CMC aspects…

Ask the Expert for Better Single-Use Powder Containment for Media and Buffers

Dave Howes (senior applications specialist at ILC Dover) introduces his company’s market-leading solution for single-use powder containment. Howes’s Presentation Some challenges in biopharmaceutical powder manufacturing include optimizing open-suite facilities; minimizing product loss from spills; lessening waste and cross-contamination; reducing worker exposure to airborne particulates; and lowering the risk of ignition with flammable materials. Characteristics to look for in a powder-transfer system are a system design that is exclusively meant for powders (not adapted from liquid-transfer designs) large-diameter top openings for…