Texcell: Innovating Biosafety and Cell Banking for the Pharmaceutical Industry
In an exclusive interview with Texcell, a leader in innovating biosafety and cell banking solutions for the pharmaceutical industry. Texcell's expertise lies in providing tailored services to meet the diverse needs of pharmaceutical companies, offering adaptable solutions spanning diagnostics, R&D, and manufacturing. With a focus on cell banking, biosafety, viral clearance, and bioassays, Texcell ensures compliance with stringent regulatory requirements while delivering exceptional quality and service to its clients. Join us as we delve into Texcell's comprehensive suite of services, its evolution over the years, and its plans for future growth and global expansion.
Can you provide an overview of Texcell’s services, particularly in the areas of cell banking, biosafety, viral clearance, and bioassays?
Texcell specializes in personalizing its services to match the unique needs of pharmaceutical companies, providing adaptable solutions for diagnostics, R&D, and manufacturing. Our cell culture and cell banking services comply with R&D, GLP, and GMP requirements. We begin with cell line establishment, then proceed to stable cell line generation and clonal selection, culminating in the creation of Research Cell Banks (RCB), Working Cell Banks (WCB), and Master Cell Banks (MCB). In addition to these upstream activities, we offer Viral Safety testing to assure the quality and efficacy of released cell banks, as well as Viral Safety Testing (VST) for downstream activities such as batch and lot release testing and potency assays. We provide Viral Clearance testing for biotherapeutics, biologics, and medical devices in Phase I/II/III trials at sites in Maryland, USA, Evry, France, and Shanghai, China. We also provide in vivo and in vitro toxicological and immunology tests that are conducted under GLP guidelines. Our global presence gives us a unique viewpoint when addressing each study and product category.
Texcell has been providing cell banking services since 1991. How has the company evolved in terms of capabilities and client base over the years?
Texcell initially focused on providing cell culture services for research and development. Our services included cell growth and expansion, cell culture optimization, and the expression of proteins, antibodies, viruses, and growth factors. As our experience grew, we optimized and created a variety of techniques, including ELISAs and customized assays, in addition to our cell growth and expansion efforts. In 2015, Texcell expanded its business by offering GMP master cell banking services.
Could you elaborate on the routinely performed cell culture services offered by Texcell, such as the generation of recombinant cell lines, cell line expansion, and cell line cryopreservation?
Texcell has considerable experience working with a variety of cell types, including monoclonal selection, scalable production, and the capacity to manufacture cell pellets. Texcell also provides services such as the establishment of research cell banks, safety testing of the cell banks, and large-scale RNA and DNA extractions from substantial cell pellets.
What upcoming projects or expansions can we expect from Texcell, and how does the company plan to continue its growth and global reach?
In 2023, Texcell enlarged its North American site to incorporate a new viral clearance facility, increasing virus safety capacity. Texcell will also complete a viral testing center in China in 2024. The expansion of these additional facilities increases the provision of services to the biopharma community.
Can you share some success stories or client testimonials that highlight Texcell’s expertise and contributions in the field of custom cell culture and virology biosafety testing?
“I wanted to express my gratitude for your help in executing this study and your hospitality. This was my first VCS and your guidance, help, and understanding made it very smooth and enjoyable. Thank you once again for accommodating our process times and requests.”
Associate Scientist, CDMO
“I completely agree with your recommendation. this looks so great! I really appreciate all the work you and your team have been doing. Seeing the quality and level of work from Texcell just made my day!”
Senior Associate Scientist Virology, Pharmaceutical Company
With Texcell’s presence in various locations globally, how does the company ensure consistency and quality across its different facilities?
At Texcell, we are dedicated to excellence. We are led by our Quality Systems, which are R&D, GLP, GMP, or GCP, and fulfill international standards such as 21 CFR and ICH principles. Each location has a Quality Review Board tasked with addressing quality issues and cultivating a culture of continuous improvement. Monthly talks are held between the heads of quality from each location to address common difficulties and exchange success stories. As an organization, we collaborate by sharing best practices and drawing on our collective experience to create a quality program that is uniform and comprehensive across all sites.
How does Texcell stay abreast of the latest advancements and regulatory changes in the pharmaceutical and biotech industries to adapt its services accordingly?
We are thought leaders who keep up with the newest biotech developments and updates to guidance materials. Texcell regularly discusses innovative and tailored techniques with clients, regulators, consultants, and industry experts. We attend conferences and host webinars to share our knowledge and experience with others. We are also pushing innovative methodologies that are consistent with new regulatory recommendations to help drive the sector ahead.
In what ways does Texcell prioritize flexibility, reactivity, and client satisfaction in its project engagements?
Texcell is both proactive and reactive, adjusting to meet each client’s specific demands. We thrive on establishing collaboration with our clients, beginning with a thorough project initiation process during which we examine historical context, viewpoints, opinions, statistics, and expectations from both the client’s and Texcell’s perspectives. Drawing on both sides’ collective experience, we create a course for each project. For the majority of projects, we organize meetings with the client to offer progress reports, allowing for real-time discussions and adjustments as needed. Adaptation is key to our strategy, and we are ready to pivot as necessary.
“At Texcell, our commitment to quality and innovation drives our adaptability and flexibility in delivering bespoke solutions for our clients in the pharmaceutical and biotech industries.”
“We believe in fostering strong collaboration with our clients, ensuring we understand their unique needs and tailor our services to exceed expectations.”
“Texcell’s global presence and consistent quality across locations reflect our dedication to maintaining the highest standards while fostering a culture of continuous improvement and excellence.”
Company Name : Texcell
Website : www.texcell.com/
Management Team
Alysia Birkholz, PhD, Chief Executive Officer
Akunna Iheanacho, Ph.D, Chief Operating Officer
