August 16, 2019

Behind Our Best Places to Work Award: Life Inside The Roost


We’re thrilled to share that we’ve been named a Frederick County Best Places to Work! This award is especially meaningful to us because our company was built with culture in mind, from our workspaces, our employee benefits, to the way we interact with our customers. 

What Makes RoosterBio a “Best Place to Work”

The Frederick County Best Places to Work is an annual campaign that showcases a company’s best practices to create an amazing place to work. The survey includes several open-ended questions centered around key components that help determine a winner. While an emphasis is placed on average median salaries and voluntary turnover rates, we wanted to share some of the key parts of our company’s culture that address other aspects of the award criteria. At RoosterBio, we’re serious about the work we do but we try not to take ourselves too seriously, and we have a little fun along the way!

Take a peek inside life at The Roost.


Attracting the Best Talent

RoosterBio is a pioneer at the forefront of a groundbreaking regenerative medicine industry with cutting-edge technology and science that attracts the brightest people from a variety of backgrounds. Employee equity in the company where everyone is a shareholder, a collaborative work environment with an open floor plan, community meeting spaces as well as a modern, open and airy laboratory space to work in - are all perks of being a Rooster.

We regularly host higher education students from across the country who are looking to further their experience in the lab, from Harvard University to the University of Virginia this year, this kind of partnership helps spread the word among academia about the kind of innovative work RoosterBio is doing. 

One of the partners we work with is the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the National Society of Black Engineers. This NIIMBL experience includes a tour and panel discussion to give students enrolled at historically black colleges and universities (HBCUs) an understanding of the kinds of careers available within biopharmaceutical manufacturing.

Retaining a Strong Workforce

Retaining our workforce is so critical that Building and Nurturing Company Culture is one of RoosterBio’s corporate and strategic objectives. It’s not just something on a piece of paper, but something we nurture and invest in every day.

The leadership team at RoosterBio believes in providing ongoing access to training and promotes transparency so much so that there is no question off-limits during our quarterly “All-Hands” Meetings. Our employees are highly engaged as measured by ongoing and anonymous surveys.


Cool Perks

RoosterBio’s workplace was built with Company Culture in mind, from glass doors on offices to promote openness, a collaborative community room to a fully-stocked kitchen that serves as the gathering spot for social events. Flexible work schedules, unlimited paid time off, a robust benefits package, access to things like financial advisors, travel planning discounts, discounted gym memberships, discounted child care and car buying discounts. In addition to 10 paid company holidays, and a floating holiday, we often shut down before holidays that isn’t a part of the communicated holiday calendar.

Promoting Fun at Work

Fun at work matters at RoosterBio because people work harder, stay longer and take better care of the organization when they’re not stressed out. The RoosterBio Culture Club plans events in five main areas: Onsite Fun, Offsite Fun, Volunteering/ Community Outreach, Employee Recognition and Health/Wellness with the mission to Make Work Awesome. We’ve celebrated everything from Take Your Child to Work Day and major holidays to things like International Haiku Day and National Scrabble Day. We recently held the 1st Annual RoosterGames at the RoosterBio Company Picnic where we put our teamwork and perseverance to the ultimate test! To relieve stress at the end of the day, you might hear the faint sound of a ping-pong ball in the distance or catch a group of Roosters at an after-hours happy hour.


Celebrating Success Together

Individual efforts are important but it’s team work that makes the dream work within The Roost. The Golden Rooster awards are for those employees who exemplify company values. These awards are nominated by fellow team members and given quarterly at “All Hands” meetings. Bonuses, additional company equity and work-sponsored celebrations are all ways that success is shared.

Not Just Culture Cluck

We are proud of what we’ve achieved together and it’s a great time to be a Rooster with even more exciting opportunities ahead. Check out our Introducing Our #Roosters campaign on LinkedIn and Facebook for testimonials from almost half of the company on what they decided to join RoosterBio. 

Check out our open positions as we expand our presence across the globe and be a part of this exciting journey.

July 15, 2019

Advances in Clinical Translation and Scale-up of MSCs and Extracellular Vesicles at ISCT 2019

Authored by Katrina Adlerz, Ph.D., Scientist, Analytics, Product & Process Development
& Josephine Lembong, Ph.D., Scientist, Analytics, Product & Process Development

The 2019 International Society for Cell and Gene Therapy (ISCT) Annual Meeting brought clinicians, regulators, and industry to Melbourne, Australia to collaborate and share progress in the rapidly developing field of Cell & Gene Therapy. Mesenchymal Stem/Stromal Cells (MSCs) were a major focus of the conference with an entire preconference workshop devoted to the Global Clinical Trial Landscape of MSCs as well as multiple sessions and keynotes throughout the conference. RoosterBio was active in the technical sessions and presented new technology on the industrial scale up of both MSCs and MSC-derived extracellular vesicles, as well as announcing a partnership with Tissue Regeneration Therapeutics to make umbilical cord -derived MSCs broadly available. Other key themes at this year’s meeting were: addressing global regulatory compliance, scalability, reducing cost of goods, exciting developments in exosomes/extracellular vesicles and recent advances in many different cell and gene therapy strategies.

MSC Progress in Clinical Trials, Manufacturing, and Comparability

Progress in clinical trials across the globe was the focus of a full day pre-conference workshop. Dr. Robert Mays of Athersys provided an update on their stromal cell product Multistem as they move into Phase III clinical trials for ischemic stroke patients and continue to investigate the treatment’s mechanism of action with immune regulation possibly being one key piece. Dr. Yufang Shi echoed this, highlighting work to pre-condition MSCs to bolster immune responses. Dr. Eleuterio Lombardo of Takeda discussed the development of Alofisel, an allogeneic MSC product that has been approved in Europe for perianal fistulas in Crohn’s disease. Some challenges in clinical trials were highlight
Photo courtesy http://www.isct2019.com/photo-gallery/
ed, such as inconsistent responses between pre-clinical and clinical studies. Dr. Lombardo pointed out an often-stated public opinion that successes in animal studies are often attributed to the use of “fresher” cells, and that these results may not be repeatable in human clinical trials because clinical trials often use cells that have been expanded and cryopreserved. Dr. Lombardo presented his review of the literature which did not support this opinion. Instead, he found that many studies did not state whether MSCs were cryopreserved or fresh, and surprisingly, it was also very rare that studies reported the Population Doubling Level (PDL). Furthermore, in his recent study where fresh and cryopreserved cells were

June 11, 2019

Cells as Bioinks for 3D Bioprinting

Authored by Mayasari Lim, PhD, Regional Account Manager, West Coast, RoosterBio

Bioprinting overview

The field of 3D bioprinting has exploded in recent years largely due to the advances in additive manufacturing technology along with progress in material chemistry and tissue engineering techniques. The key ingredients that make up the complex bioprinted structures are comprised of hydrogel-based biomaterial/s often coined as ‘bioinks’ and a cellular component that serves as building blocks to create a 3D printed biological tissue. Clearly, the choice of the cell source, proteins and other biological ingredients depends largely on the desired final application. For the purpose of this blog, we will only focus on the desire to create bioprinted tissue for clinical translation.

Which cell should I use?

Cells for clinical use can be derived from the patient (autologous) or a donor (allogeneic). In many tissue engineering applications, stem cells are used due to their properties in self-renewal and differentiation. Adult stem cells, currently being the most clinically viable solution, include hematopoietic, mesenchymal, neural and epithelial. While hematopoietic stem cell transplantation is widespread, it has limited utility in tissue engineering applications due to its limited differentiation capabilities primarily toward blood lineages. Neural stem cells are most effective in neural regeneration but the limited source makes it very challenging to become clinically relevant. Mesenchymal stem/stromal cells (MSCs), on the other hand, has a significant advantage due to its tri-lineage differentiation ability and immunomodulatory functions thus it has been widely used in various therapeutic indications including brain trauma, graft-versus-host disease and cardiovascular disease. Moreover, MSCs have already demonstrated clinical safety in > 800 clinical trials treating over 30,000 patients to-date.

How many cells do I need?

In order to print a 3D tissue, we need a significant number of cells seeded at a relatively high density to achieve full tissue mimicry. Exactly how many cells would one require? Let us take a look at a simple example of the knee meniscus. The figure below (left) illustrates a 3D model of an adult meniscus with rough dimensions of 3.5 cm in diameter and 5.3 mm in height. If we were to print this structure at 30% infill, it would require a total volume of ~2.5 mL of bioink. Several studies in bioprinting cartilage tissues have reported that cells would need to be seeded at high densities, a minimum of 10-25 million cells/mL in order to form cartilage in vivo[1, 2]. Thus, in this print, we would require roughly 62.5 million MSCs for a single print. For an intervertebral disc with a diameter of 4 cm and height of 10 mm (Figure on the right), the total volume of bioink required to perform a print would be 4 mL thus the total number of cells required would be 100 million for a single print. These two examples serve to illustrate the number of cells required to bioprint a simple 3D tissue. For larger tissues or organs, one can imagine that you will need a significantly higher number of cells, in the orders to 10 billion or more, to achieve desirable cell distribution through the tissue.


Traditional methods of expanding MSCs in the lab using 2D tissue culture flasks will require significant amount of time (weeks) and labor to obtain enough cell numbers given that most commercially available MSC vials are sold in 0.5-1 million cells/vial. Fortunately, RoosterBio has developed a ready-to-print cell vial (RoosterRTP™) with 50 million cells in each vial that significantly reduces and/or eliminates the need for growing cells in the lab so that researchers in the field of tissue engineering and bioprinting can focus on their research rather than worry about optimizing their expansion protocols. At the development stage, this would significantly reduce the amount of time for researchers to conduct multiple experiments thus generating more data in a shorter time. To scale such a process for commercial production, it would be necessary to estimate the required manufacturing lot size as described in our previous blog to build an effective multi-year process development program. In the case of the knee meniscus, there are over 700,000 patients requiring meniscus surgery in the US alone. To supply even 20% of this requirement, one would require 140,000 bioprinted knee meniscus which would be equivalent to 8.75 trillion cells annually.

References:

1. Cohen et al., 2018. Tissue engineering the human auricle by auricular chondrocyte-mesenchymal stem cell co-implantation. PLoSOne13(10): e0202356. doi: 10.1371/journal.pone.0202356

2. Moller et al., 2017. In vivochondrogenesis in 3D bioprinted human cell-laden hydrogel constructs. Plast Reconstr Surg Glob Open. 5(2): e1227. Doi: 10.1097/GOX.000000000000127