New Bioanalytical Testing Laboratory

In November 2016, Sartorius Stedim Biotech (SSB) opened a new bioanalytical and biosafety testing laboratory in the biotech hub area of Boston, MA. This dedicated laboratory is designed to accommodate rising North American demand for the company’s BioOutsource specialized assay platforms and facilitate ongoing expansion of products and testing services. The company performs a range of testing for biologics, vaccines, and biosimilars throughout their development and manufacture.

Reinhardt Vogt is a member of SSB’s executive committee. In welcoming representatives from the biopharmaceutical industry and the local community to this new facility at its opening ceremony, he said it “will offer customers the analytical expertise to help them accelerate entry into clinical phases. We chose Boston as the site for our laboratory because it is a premier biotech hub, enabling us to showcase our portfolio of bioanalytical and biosafety tests, as well as attract the best technical staff to continue our expansion here in the future.”

The purpose-built facility features state-of-the-art technology for advanced bioanalytical testing (e.g., Biacore analytical instruments from GE Healthcare for measuring surface plasmon resonance, SPR). Services include antibody-dependent cell cytotoxicity (ADCC); complement-dependent cytotoxicity (CDC), SPR, cellbased assays, and enzyme-linked immunosorbent assays (ELISAs). The new laboratory covers about 9,000 ft2 (830 m2) and will provide good manufacturing practice compliant polymerase chain-reaction (PCR) and in vitro assays for detecting adventitious agents. Bioanalytical experts (including 15 scientists) will provide easy access for customers to visit and meet face to face for discussing technical questions.

Bioscience Skill Standards from National Community College Consortium

In November 2016, a consortium of 12 community colleges from across the country completed a four-year project — with a grant from the US Department of Labor — to create industry-recognized credentialing standards for developing a skilled bioscience workforce. The 2012 US$15 million Trade Adjustment Assistance Community College Career Training (TAACCCT) grant was part of an initiative that supported President Barack Obama’s goal of having the world’s highest proportion of college graduates in the United States by 2020. The National Center for the Biotechnology Workforce (NCBW, an affiliate of NC BioNetwork based at Forsyth Technical Community College in Winston-Salem, NC) leads the National Community College Consortium.

As part of that program, the Community College Consortium for Bioscience Credentials (“c3bc”) includes 35 biotechnology educators from around the country. They collaborated to establish bioscience industry skill standards, credential programs, and breakthrough delivery training methods to expand access to bioscience education and training opportunities for students, displaced workers, and veterans. Their goal has been to help the high-growth bioscience industry identify ways to recruit, hire, and build careers for entry-level technicians in its complex marketplace. The group focuses on medical devices, biomanufacturing, and biosciences laboratory skills as well as technologies.

In under four years, the c3bc has engaged more than 170 colleges, employers, bioscience industry groups, and workforce organizations to serve more than 3,000 students and with groundbreaking results. The consortium has created a set of core bioscience skill standards used by educators nationwide to design fundamental curriculum, by employers to evaluate their own training programs and student internships, and by employees to understand the key work functions they need to know to be successful in a biopharmaceutical workplace. Four new two-year associate programs and 19 new certificate programs have been introduced. Development of cutting-edge processes, training delivery methods, and resources to help students more easily attain the credentials they need include extended laboratory hours, online and hybrid courses that reduce textbook expenses and scheduling barriers, and virtual tools that provide interactive instruction, assessments, and links to additional resources. One tool is the free and open online library at SkillsCommons.org.

“The c3bc was an idea in 2012 that became a reality with TAACCCT funding,” says Russ H. Read, c3bc project director and executive director of the NCBW. “Four years later, we can see how the fruits of our labor tie in very nicely for bioscience workforce education and training trends and needs expressed by educators, employers, and workforce agencies.”

According to Gary Green (president of Forsyth Technical Community College), the c3bc’s success can be attributed to exceptional leadership by project director Read and others. “It’s also important to thank the consortium member’s college presidents for recognizing that the c3bc personnel could not do their jobs without their institutions’ support and guidance.”

“Technically skilled, multidisciplinary, and interdisciplinary people can talk across different issues,” says William Pratt, vice president of operations and director of creative design at Kinamed (a designer and manufacturer of implants and surgical instruments in Camarillo, CA). “They are the employees that really make our factories go.”

For more information, see the website at http://biotechworkforce.org.

Opening Up Clinical Data on New Medicines

Beginning in October 2016, the European Medicines Agency (EMA) now provides open access to clinical reports on all new European Union (EU) authorized medicines for human use. For every new medicine, citizens, doctors, and researchers can directly access clinical reports submitted to EMA in drug companies’ market-authorization applications. Clinical reports include information on methods used and clinical trial results. The EMA is the first regulatory authority worldwide to provide such broad access to clinical data.

Vytenis Andriukaitis (European Commissioner for Health and Food Safety) says, “Transparency is an essential component in clinical research. Its outcome — whether positive or negative — should be made publicly available.” This transparency initiative, he says, makes Europe a “true front runner” in release of clinical trial data.

“Transparency on clinical data is a long-standing commitment from EMA and today,” explains the EMA’s executive director Guido Rasi, “we are delivering on our promise to give access to the data on which our recommendations are based. Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole.”

With the EMA’s proactive approach, patients and healthcare professionals will be informed about the data underpinning approval of medicines they are taking or prescribing. This will facilitate independent reanalysis by academics and researchers after medicines are approved, ultimately increasing scientific knowledge and further informing future regulatory decisions. Increased transparency also will benefit innovation. Shared knowledge about a medicine helps developers learn from others’ experience and could lead to more efficient drug development programs.

“Patients and clinicians have been waiting a long time for clinical trial data,” comments Yann Le Cam, chief executive officer of EURORDIS-Rare Diseases Europe and a member of the EMA’s management board. “This new approach will at last provide transparent information on all results of clinical trials (positive or negative) as submitted to the EMA. We expect this to enhance trust in the medicines approval system. Access to this new knowledge base can help to accelerate innovation by reducing duplication of research and derisking some new developments.”

Innovative Policy on Proactive Publication of Clinical Data: This follows the EMA’s adoption of a 2015 policy on publication of clinical data for human medicines. During its development, the agency consulted with stakeholders to integrate their sometimes divergent views. A website at https://clinicaldata.ema.europa.eu will include clinical reports from all initial market-authorization applications submitted on or after 1 January 2015. This also applies to applications submitted on or after 1 July 2015 to change indications or extend lines. These documents are published once the European Commission decides whether or not to grant market authorization; they also will be published when applications are withdrawn before the EMA gives its official opinion.

As a first step, the agency has published data for two medicines: ~260,000 pages of information from more than 100 clinical reports. Data will be added progressively over time for all applications made since the policy entered into force. This presents a learning curve for the agency and all its stakeholders. Although the policy provides unprecedented access to clinical data, it also demands the highest standards of protection for patients’ personal information. The process will evolve over time as more experience is gained and adaptations are made to EMA guidances.

Once the process is fully implemented and the backlog has been dealt with, the agency intends to publish a report 60 days after its decision on each application or within 150 days after receipt of a withdrawal letter. Although committed to those timelines, the EMA might reassess their feasibility given the volume of work involved. According to current forecasts, the agency expects to offer access to some 4,500 clinical reports each year.

A Collaboration for Biomanufacturing

Biogen is partnering with the Bill & Melinda Gates Foundation in researching new biomanufacturing methods to improve production of therapies based on monoclonal antibodies (MAbs). “During the past 40 years, the demand for antibody-based medicines has increased more than a thousand-fold,” says Jorg Thommes, the company’s senior vice president of technical development. With a focus on eradicating infectious diseases and improving access to high-quality healthcare in the developing world, he says, the Gates Foundation seeks ways to transform production methods so that biopharmaceutical companies can serve large patient populations. If MAb-based therapies in development for diseases such as malaria are successful, Thommes points out, market demand for them could far exceed the capabilities of current production technologies.

Exploring alternatives to traditional mammalian cell expression in large-scale bioreactors is the focus of this project. Biogen will test eight different expression systems, ranging from yeast and fungi to algae, for their potential to produce MAbs at greater productivity levels than are currently possible. Results are expected in 12–18 months and will be made publicly available.

“Through this project, we may find that our current biomanufacturing techniques are still the best approach,” Thommes cautions. To serve large patient populations, the industry simply would need to build more traditional facilities. “But what if we could use yeast, fungi, or algae as more productive expression systems and still produce high-quality proteins in much larger quantities without building more facilities? We believe this may be possible and could unlock even greater potential to improve the health of people around the world.”