November-December 2018

Launched in June 2018, the BioProcess Insider digital information portal delivers the latest financial and business news and expert insider views influencing the commercialization of biopharmaceuticals. Here are just a few recent stories edited for our space limitations in print. For more discussion and in-depth analysis, check out the website at www.bioprocessinsider.com . Every edition provides expert and insider perspectives on current financial movements and deal-making; the newest technology purchases and capacity investments; regulations affecting the bioprocessing sector; global market actions and reactions; and industry trends. Janssen Opens HIV Vaccine Plant Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, has opened a new single-use biomanufacturing facility to support commercialization of a preventative human immunodeficiency virus (HIV) vaccine candidate in development. Representing an investment of €72 million ($82 million), the multipurpose vaccine-production facility was inaug...

WWW.ISTOCKPHOTO.COM Pursuant to the proposal for validated minimum standards for biopharmaceutical contract manufacturing organization (CMO) request-for-information (RFI) and request-for-proposal (RFP) processes ( biopharmaceutical vendor evaluation and selection minimum standards , BioVesel) ( 1 ), we propose herein a multistep research protocol to develop and implement the BioVesel standards. This proposal is intended as a basis for discussion among mulitple stakeholders. Detailed research protocols for each proposed stage in the development and implementation of BioVesel will be drafted and published separately. The context of the proposed research is an exercise to gather and synthesize the opinions of stakeholders involved in the evaluation, acquisition, provision, and oversight of biopharmaceutical CMO services (Table 1). Table 1: Overview of stakeholders engaged in contract manufacturing organization (CMO) service evaluation, acquisition, provision, and oversight Table 1 shows the many stakeholders...

HTTPS://STOCK.ADOBE.COM On Thursday 6 September 2018 at the annual BioProcess International Conference in Boston, the first “Technology Round Robin Featuring Six Innovative Bioprocess Technologies” was presented in an interactive session with attendees as active participants, asking questions and engaging in conversation with the six featured entrepreneurs. Detailed below, this session was a culmination of several steps in an overall strategy for some of the companies participating. To fully appreciate the launch of new technologies into the bioprocess arena, you first must understand the challenges faced by such early stage suppliers and what we can do to support technology development and innovation in support of the biopharmaceutical industry. Figure 1: The “valley of death” in biopharmaceutical drug development Drug development has an identified “valley of death” that comes when the gulf widens between finding a promising new therapy and moving to the necessary clinical trials that can demonstrate its...

STOCK.ADOBE.COM In earlier issues of BPI we published a few “Elucidation” closers that we called “Defining Moments.” Since then, we have tried to distinguish key confusable terms from one another. Those presented (and sometimes “elucidated”) have been analytical and bioanalytical , spectroscopy and spectrometry , and biosimilars and biobetters . They are just a few of the many confusable terms in the biopharmaceutical industry. For example, when someone says “drug delivery,” a formulator will think of a syringe or transdermal patch, but a logistics expert will think of packaging or a truck. Figure 1: Most survey participants reside and work in Europe or North America. The term biopharmaceutical itself was coined more to distinguish that category of recombinant large biomolecules from what was then the more familiar “classical” or small-molecule drugs — those chemically synthesized drug substances that can be delivered mainly through oral formulations. In fact, the word biopharmaceutical was coi...

Figure 1: The product cycle model of innovation ( 1 ) Most commercial biopharmaceuticals originated from academic research laboratories and start-up development laboratories. Despite such products having differences in modalities and targeted disease indications, and whether their target patient populations are relatively small or approaching blockbuster status, at a key point in development, biopharmaceutical production must scale up from laboratory to commercial production. That movement from research to development and then to manufacturing forces attention on economics and speed to market, and it drives innovative approaches to producing biopharmaceutical cell compositions at commercially relevant scales and at cost structures that support business models. Regenerative medicines, whether for cell therapies or biofabricated tissues, now face that same transition. Bioprocess developers require a steady supply of consistent, highly functional, highly viable cells at large volumes for both product and pro...

In commercial-scale biopharmaceutical manufacturing, downstream chromatography steps are still a bottleneck and contribute to significant operational costs ( 1 , 2 ). Some of those costs are inherent (e.g., resins, large buffer quantities, and cleaning) whereas others are avoidable (e.g., product loss due to rejected lots or deviations that result in production downtime). Maintaining efficient and robust chromatography process performance is therefore critical for minimizing operating costs. To do so, we introduce a simple and one-point multiparameter technique (SOP-MPT) for monitoring chromatographic process performance. Traditionally, chromatography process performance has been monitored by analytical assays (e.g., those measuring yield, impurities, and molecular integrity) along with visual review of chromatographic profiles by trained personnel. However, such techniques have limitations. Analytical assays are performed for each production lot but not necessarily at each process step, thus creating ga...

FortéBio’s Octet instruments are an ideal replacement for ELISA, HPLC, and SPR techniques in quantification of antibodies and recombinant proteins and in testing product potency for lot release. Bio-Layer Interferometry (BLI) technology monitors biomolecular interactions in real time to determine affinity, kinetics, and concentration. The plate-based, microfluidics-free format offers users several distinct advantages over other technologies. BLI-based systems can achieve higher throughput, with the flexibility to measure two to 96 samples simultaneously. Lower maintenance requirements and increased ease-of-use further shorten the time it take to get results. Increased system flexibility — including an ability to analyze unpurified samples and tolerate a broad range of conditions — is another time-saving hallmark. With additional tools to enable integration into regulated environments, the Octet systems can be instituted across biologics development. Figure 1: Overlay of several replicates of FcRn–IgG inte...

Veterans of the US military still struggle to access healthcare despite the 2014 congressional passing of the Veteran’s Choice Program (VCP), a US$10 billion-dollar “fix” that allows qualifying veterans to see community physicians who have contracted with the Department of Veterans Affairs (VA) to provide care. Veterans who enrolled in VCP to avoid long wait times at department medical facilities still have faced month-long delays before seeing a doctor, according to a 2018 GAO report . Investigators have found that the VA protocol for scheduling VCP appointments caused veterans to wait up to 81 days for treatment and an average 51 days to receive care, despite the VA’s own standard to administer care within 30 days of a patient’s request. One key factor in the failed implementation of VCP could be the excessive delay in physician reimbursement that ultimately is driving away community provider participation in the program. Hospitals, clinics, and doctors across the country have complained about not gett...