The list of conditions being targeted by cell therapies is rapidly growing, but commercializing cells for widespread medical use will require standardized laboratory practices. Development processes must be adapted specifically for cell-based drug products. Regulatory T-cell therapy represents a promising new frontier in the immunotherapy of autoimmune disorders, especially for patients who have been refractory to available treatments. Because of intrinsic fragility, cell therapy products can be highly sensitive to variations in manufacturing procedures. Standardization of drug-product cryopreservation and storage…
Economics
Bioprocess Advances Drive Vaccine Manufacturing in Developing Countries
Advances in bioprocessing technology hardware and genetic engineering are expanding the geographic options for biologics manufacturing to include developing and emerging economies. Such advances are beginning to permit biopharmaceutical production in regions that previously lacked the technical expertise or quality processes to permit complex operations, monitoring, record-keeping, and oversight. Global demand by countries for in-country production of biological vaccines is increasing, so those products tend to be leading the way in terms of adoption of modern bioprocessing in developing countries.…
Evolving Biologics Demand Spurs New Facility Needs
In the era of biologics manufacturing, chemical medicine production facilities are becoming the dinosaurs of the life sciences sector. Traditional chemical facility development and management systems are simply unequipped to support the highly sensitive — and highly regulated — process of developing and producing biological and biosimilar medicines. Renovating or building such facilities anew is a mammoth undertaking by any measure. All signs point to the value of evolving facility design and management to house more sophisticated biologic laboratory services.…
Innovation in Biopharmaceutical Manufacture
The following is a report from a workshop on innovation in biopharmaceutical manufacturing held at the Annual bioProcessUK Conference in Bristol on 29 November 2012. The aim of the workshop was to access the experience of practitioners in the United Kingdom so as to understand better the challenges and opportunities for innovation in this sector. The workshop addressed the drivers that influence the implementation of process improvements and novel technologies in biopharmaceutical manufacture from the perspective of both manufacturers and…
Optimizing for the Future
The 2013 biennial meeting of the European Society for Animal Cell Technology (ESACT) was in Lille, France this past June. While there, BPI editorial advisor Miriam Monge (vice president of Biopharm Services Ltd.) interviewed ESACT executive committee member Hitto Kaufmann, PhD (vice president of biopharmaceutical process sciences for Boehringer Ingelheim). They talked about some scientific developments being discussed at this year’s ESACT conference as well as Boehringer Ingelheim’s recent announcement about setting up in China and Kaufmann’s own thoughts on…
Outsourcing Facility Safety for Biomanufacturing
As the life-science industry increasingly outsources noncore functions, some companies are finding that managing the expanding web of safety and environmental requirements associated with various functions is, in turn, growing vastly more complex. As multiple third parties handle numerous noncore activities, the risk — and headaches — of monitoring them effectively is a growing challenge by any standard. At first glance, the lowest-risk solution for many organizations may seem to be managing associated safety programs with in-house personnel and programs.…
Responding to Life Sciences Manufacturing Industry Guidance
Increasingly, life science manufacturing companies are applying technology to meet quality by design (QbD) goals. Organizations collect overflowing volumes of process data as part of programs designed to improve manufacturing variability and outcomes. Collecting valuable data is now an everyday task thanks to available software and process analytical technology (PAT) tools. The industry today, in fact, has focused so much on gathering data that it often has lost sight of an important fact: Data collection systems are valuable only if…
A Global Joint Venture Strategy for Biosimilars Development
In April 2013, biopharmaceutical company Pfenex (San Diego, CA) announced a joint venture with biologics manufacturer Stelis Biopharma, Inc. (“Stelis”), earlier known as Agila Biotech, (a wholly owned subsidiary of Strides Arcolab Limited (Bangalore, India) for the commercial development of six biosimilars. The companies will also leverage technology and global development expertise from GE Healthcare Life Sciences (Uppsala, Sweden) and Bio-XCell Malaysia (Nusajaya, Malaysia). Such international, multicompany collaboration strategies have become a growing trend in the highly competitive biosimilars industry.…
Benefits of Business Process Management
The biopharmaceutical sector is synonymous with innovation. There is a general sense, however, that biomanufacturers often don’t “have their houses in order” when it comes to adopting efficient processes, communications, and reporting tools. Indeed, many companies still rely on outdated methods to support areas such as research and development (R&D), manufacturing, clinical trials, and sales and marketing. That is especially true now that the biopharmaceutical sector is undergoing an acquisitory revolution of both rival companies and products. The industry has…
Government Medicaid Reporting
On 27 January 2012, the US Centers for Medicare and Medicaid Services (CMS) published a much-anticipated proposed average manufacturer price (AMP) rule for implementing related prescription drug provisions of the Patient Protection and Affordable Care Act (PPACA). The new rule will create serious financial, administrative, and operational challenges for the life-sciences industry. Nearly two years later, the final rule has not been issued. Without official direction, we can look back at the proposed rule’s purpose and recommendations for manufacturers based…