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Bionova Scientific ® opens new pDNA facility in Texas to support rapidly growing biopharma industry

Bionova Scientific ® opens new pDNA facility in Texas to support rapidly growing biopharma industry

Business Wire3 days ago
HOUSTON--(BUSINESS WIRE)--Bionova Scientific ®, a full-service biologics contract development and manufacturing organization (CDMO) and subsidiary of global conglomerate Asahi Kasei, has announced the opening of a 10,000 square-foot state-of-the-art plasmid DNA (pDNA) development and production facility in The Woodlands, Texas.
Located less than 30 miles north of Houston, Texas, the new facility designs, develops and manufactures research-grade pDNA materials to support the cell and gene therapy field. With the global pharmaceutical market anticipated to reach almost $3 trillion by 2033, Bionova Scientific has positioned itself to effortlessly accommodate the market's rapid growth. Enabled by the new Texas facility, the company will expand its offerings beyond mammalian protein production and provide clinical to commercial-scale Current Good Manufacturing Practice (CGMP) production of pDNA by Q4 2025.
Plasmid DNA is a critical starting material for advanced therapeutics, including mRNA and viral vector-based cell and gene therapies (CGTs). Adding pDNA development and manufacturing services enhances Bionova Scientific's established expertise in antibody and protein CDMO services, already offered via its recently expanded flagship facility in San Francisco's Bay Area. Through these added services, Bionova is broadening its portfolio across biotherapeutic modalities to serve more customers.
This strategic expansion is not just about capacity, it's about evolving alongside the next generation of advanced therapy developers and meeting their unique needs with the same quality, flexibility, and scientific rigor that have defined Bionova's existing partnerships in protein development and GMP manufacturing out of Fremont, CA.
'Bionova added these highly sought-after pDNA capabilities in response to a persistent unmet need among the cell and gene therapy biopharma community. Completing this specialized facility on schedule is not only a milestone for our team, but a crucial step in ensuring our customers receive the reliable, timely support they need to meet their own deadlines,' commented Darren Head, President and Chair of Bionova. 'We chose The Woodlands because of its proximity to a growing number of CGT companies, and its location provides Bionova with access to the rapidly expanding CGT ecosystem here in the U.S. By aligning our capabilities with the needs of the CGT sector, we look forward to building lasting partnerships that accelerate the industry.'
As a core growth driver within Asahi Kasei's Life Science group, Bionova continues to scale its presence to meet the evolving needs of the biopharmaceutical industry. Backed by Asahi Kasei's medium-term management plan, which prioritizes expansion across its virus filtration, CRO testing, and CDMO businesses, Bionova is positioned to lead in delivering high-impact solutions for next-generation therapies. The company's ongoing investments in specialized capabilities underscore its role at the forefront of Asahi Kasei Life Science's strategy.
To learn more about Bionova Scientific, visit https://bionovascientific.com/.
About Bionova Scientific
Bionova Scientific partners with innovators in the biologic industry to bring life-changing therapies to market with a dedication to quality and service. Founded in 2014 and acquired by Asahi Kasei Group in 2022, Bionova Scientific offers our client partners access to advanced technological platforms, and a strong commitment to quality delivered with scientific excellence across the entire lifecycle of your drug product. As an integrated CDMO, Bionova provides services that span discovery through cGMP commercial supply of complex therapeutic proteins and antibodies. Our experienced scientists bring proven expertise to overcome discovery to first-in-human development challenges and enabling efficient and easy scale-up. In 2025, Bionova expanded its capabilities with the launch of a dedicated plasmid DNA (pDNA) development and manufacturing facility in Houston, Texas, further strengthening our position as a trusted partner in advanced therapy production. Bionova is a flexible and collaborative partner that has worked with leading biotechnology innovators from its new state-of-the-art facility in the San Francisco Bay Area. For more information, visit bionovascientific.com
About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Healthcare, Homes, and Material. For more information, visit asahi-kasei.com and ak-bio.com.
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U.S. Pharmaceutical CDMO Market Valuation to Surpass USD 68.57 Billion by 2034
U.S. Pharmaceutical CDMO Market Valuation to Surpass USD 68.57 Billion by 2034

Yahoo

time3 hours ago

  • Yahoo

U.S. Pharmaceutical CDMO Market Valuation to Surpass USD 68.57 Billion by 2034

The U.S. pharmaceutical CDMO market is estimated at USD 39.14 billion in 2025 and is projected to reach approximately USD 68.57 billion by 2034, expanding at a CAGR of 6.43% over the forecast period. Ottawa, Aug. 13, 2025 (GLOBE NEWSWIRE) -- According to a study by Towards Healthcare, a sister firm of Precedence Research, the U.S. pharmaceutical CDMO market was valued at USD 36.77 billion in 2024 and is projected to reach approximately USD 68.57 billion by 2034, growing at a CAGR of 6.43%. The rising commercial scale-up in different therapeutic areas in the US and growing adoption of digital technologies are fueling overall market expansion. The Complete Study is Now Available for Immediate Access | Download the Sample Pages of this Report @ Key Takeaways By product, the API segment dominated the U.S. pharmaceutical CDMO market in 2024 and is expected to grow fastest during the forecast period. By workflow, the commercial segment held the largest revenue share of the market in 2024. By application, the oncology segment registered dominance in the market in 2024. By end-use, the large pharmaceutical companies segment was dominant in the U.S. pharmaceutical CDMO market in 2024 and is expected to grow rapidly in the studies years. Market Overview & Potential Companies that are offering comprehensive services to different pharmaceutical and biotechnology companies, including both drug development and manufacturing in the US, are referred to as U.S. pharmaceutical CDMO market. Primarily, they provide expertise and resources for these companies. In 2025, they are focusing on novel drug discovery and development in oncology and other chronic conditions with the increased adoption of advanced production technologies. Moreover, the US is widely investing in robust and advanced infrastructure to fulfil the requirements of the increasing demand for specialized services, particularly in areas like biologics, sterile injectables, and gene and cell therapies. What are the Key Drivers Involved in The Growth of The Market? The U.S. pharmaceutical CDMO market has major dominating factors in its expansion, including crucial support to small and mid-sized pharmaceutical companies. These companies are facing the limitations of infrastructure for large-scale production with enhanced dependence on CDMOs for numerous stages of development and manufacturing. Also, benefits of pharmaceutical CDMOs, like scalability, flexibility, and cost-effectiveness, are fueling the expansion of the market with reduced capital investments. Besides this, experts working in CDMOs can navigate the complex regulatory landscape and check the compliance with standards like GMP (Good Manufacturing Practices). What are the Trends Associated with the U.S. Pharmaceutical CDMO Market? Different companies in the US are highly adopting outsourcing production to CDMOs to handle expenses and emphasis on competencies. Alongside, continuous advances in technologies and regulatory frameworks also play a crucial role in this market development. In May 2025, CDMO Piramal Pharma Solutions announced $90 million investment into its US manufacturing facilities. In March 2025, LGM Pharma, a global provider of customized API and CDMO services for the full drug product lifecycle, invested $6M in U.S. drug manufacturing capabilities for liquids, suspensions, semi-solids, and suppositories. You can place an order or ask any questions, please feel free to contact us at sales@ What Is the Emerging Challenge in the Market? Challenges connected with the U.S. pharmaceutical CDMO market include geopolitical stress, lack of raw material, and pandemic-related disturbances, are contribute as barriers in the production and delivery. Along with this, the rising need for a skilled workforce and specialized knowledge in continuous manufacturing and advanced bioprocessing demands vital investment in training and development. Country-level Analysis The U.S. pharmaceutical CDMO market is experiencing widespread expansion due to broader demand for a variety of biologics and biosimilars which are used in novel rare cases and other severe health issues. Besides this, ongoing technological breakthroughs in process chemistry and manufacturing automation are boosting the efficiency and quality of drug production, further propelling the adoption of CDMO services. As well as escalating cases of diverse cancers is assisting the development of novel cancer therapies, including targeted therapies and immunotherapies. For this market, In June 2025, Agenus Inc., a U.S.-based biotechnology company specializing in immuno-oncology, entered into a partnership with $141M Zydus investment to transform the immune-oncology area. Segmental Insights By product analysis How did the API Segment Lead the U.S. Pharmaceutical CDMO Market in 2024? The API segment was dominant in the market in 2024 and will grow rapidly during 2025-2034. An escalating demand for both traditional and complex APIs, especially in small molecule drugs, is fueling the segment's growth. In this segment, synthetic APIs experienced major demand, which are highly employed in numerous therapeutic areas such as cardiovascular, analgesic, and CNS drugs, making them an important driver in the API CDMO market. Also, this segment is moving towards continuous manufacturing, process analytical technology (PAT), sustainability, and digitalization, with enhanced focus on specialized CDMOs catering to niche therapeutic areas and expansion in biotech API development. Become a valued research partner with us - By workflow analysis What Made the Commercial Segment Dominant in the Market in 2024? In the U.S. pharmaceutical CDMO market, the commercial segment captured a major revenue share in 2024. Across the globe, one of the vital factors contributing to the overall market expansion is improved focus on the large-scale manufacturing of pharmaceuticals and biopharmaceuticals for commercial distribution. Moreover, widespread involvement of specialized expertise in biologics, cell & gene therapies, and mRNA vaccines necessitates sophisticated and specialized manufacturing capabilities. Additionally, CDMOs are boosting their service offerings by expanding collaboration with other organizations and companies to incorporate the complete drug development and manufacturing lifecycle, from early development to commercial launch. By application analysis How did Oncology Dominate the U.S. Pharmaceutical CDMO Market in 2024? The oncology segment registered dominance with the biggest share of the market in 2024. Eventual growth in cancer cases, with the progression of personalized therapies and targeted treatments, is impacting segment expansion. US CDMOs are stepping towards the transformation of advanced therapies, especially cell and gene therapies, antibody-drug conjugates, and bispecific antibodies, which are a major part of oncology clinical trials. These therapies are widely propelling demand for specialized facilities and expertise in handling potent APIs, cytotoxic compounds, and sterile injectables. By end-use analysis How did the Large Pharmaceutical Companies Hold a Major Share of The Market in 2024? The large pharmaceutical companies segment led the U.S. pharmaceutical CDMO market in 2024 and is anticipated to witness the fastest growth during 2025-2034. Nowadays, a rise in innovation investments, mainly in data analytics and AI, is assisting overall drug development processes and ultimately enhancing productivity. Apart from this, these companies are focusing on the utilization of advanced formulation technologies in specific areas, especially oral peptide formulations and permeation enhancers, to optimize drug delivery. These companies frequently grasp their robust infrastructure, scientific expertise, and global networks, which make them attractive for further collaborations and outsourcing to CDMOs in the US. Get the latest insights on healthcare industry segmentation with our Annual Membership: Ongoing Developments in the U.S. Pharmaceutical CDMO Market In July 2025, ESTEVE acquired Regis Technologies, a United States-based Contract Development and Manufacturing Organization (CDMO), to accelerate its contract development and manufacturing services for small-molecule active pharmaceutical ingredients from pre-clinical to commercial manufacturing in the US. In May 2025, Purdue University and a collaboration of leaders in AI, pharmaceutical manufacturing, and public policy launched a national effort in the Dirksen Senate Office Building to boost pharmaceutical manufacturing in the United States by revealing cutting-edge AI and advanced manufacturing technologies. In May 2025, Benuvia Operations, LLC, a U.S.-based global Contract Development and Manufacturing Organization (CDMO) and Active Pharmaceutical Ingredient (API) supplier, signed a multi-year supply agreement with a prominent U.S. pharmaceutical company to support the company's product development activities. Key Players in the U.S. Pharmaceutical CDMO Market Adare Pharma Solutions AGC Biologics Agilent Technologies Catalent Pharma Solutions Exela Pharma Sciences PCI Pharma Services Pfizer CentreOne Scorpius BioManufacturing Sharp Services Single Use Support Thermo Fisher Scientific UPM Pharmaceuticals, Inc. Browse More Insights of Towards Healthcare: The global bioconjugation market reached USD 5.52 billion in 2024, rose to USD 6.37 billion in 2025, and will likely hit USD 23.18 billion by 2034, expanding at a CAGR of 15.46% from 2025 to 2034. The U.S. residual DNA testing market continues its upward trajectory and is set to generate substantial revenue growth, potentially reaching hundreds of millions by 2034. The worldwide life science CDMO market is expanding significantly and is projected to record several hundred million dollars in additional revenue by the end of the forecast period from 2025 to 2034. The global veterinary CRO and CDMO market stood at USD 7.17 billion in 2024, increased to USD 7.77 billion in 2025, and will likely reach USD 16.13 billion by 2034, growing at a CAGR of 8.43% between 2025 and 2034. 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You can place an order or ask any questions, please feel free to contact us at sales@ Europe Region - +44 778 256 0738 North America Region - +1 8044 4193 44 Web: Find us on social platforms: LinkedIn | Twitter | Instagram | Medium | Pinterest

Tivic Reports Second Quarter 2025 Financial Results
Tivic Reports Second Quarter 2025 Financial Results

Business Wire

timea day ago

  • Business Wire

Tivic Reports Second Quarter 2025 Financial Results

FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (NASDAQ: TIVC), a diversified immunotherapeutics company, today announced financial results for the second quarter and six months ended June 30, 2025. 'We have established a strong foundation for Tivic's strategic transformation with our expansion into biopharmaceuticals, making us unique in treating disease by addressing both the body's biochemical and bioelectronic systems,' stated Tivic CEO Jennifer Ernst. 'To maximize our focus on the compelling, late-stage clinical pipeline, we have increasingly shifted resources away from consumer healthtech and are now planning to exit the ClearUP business by the end of this year,' continued Ernst. 'I look forward to advancing the commercialization of these life-saving therapies, supporting our strategy to increase shareholder value through this transformation.' Corporate Highlights from the Second Quarter and Subsequent Weeks, included: Securing positive interest in potential military and defense applications for drug candidate Entolimod™ to treat ARS during briefings with the White House and U.S. Food & Drug Administration (FDA) officials. Extending the worldwide license of Entolimod™ to include the treatment of neutropenia, a condition that reduces the body's ability to combat infections and has a wide range of causes - from genetics to cancer treatments and age. Entering into a GMP manufacturing validation agreement with Scorpius Biomanufacturing, Inc. as part of preparing for the FDA biologics license application process. Completing all study visits in the Optimization Study for its patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. Raising $1.4 million from the first and second tranche of a preferred equity purchase agreement that provides for up to $8.4 million in total financing. Entering into a $25 million equity line of credit that generated net proceeds of $547,000. Receiving shareholder approval of key measures in support of Tivic transformation strategy. Expanding biopharmaceutical team with regulatory, clinical and business development staff. Naming Lisa Wolf as CFO following her nine-month tenure as interim CFO. Financial Performance: Revenue (net of returns) for the three and six months ended June 30, 2025 totaled $86,000 and $156,000, respectively, compared with $140,000 and $474,000 for 2024. The decreases are due to lower unit sales of ClearUP™ to treat sinus pain and pressure. The lower sales are attributable to decreases in advertising expenses as the company focused resources on accelerating its TLR5 program for the development of Entolimod™ for ARS. Gross profit in the three and six months ended June 30, 2025 was $54,000 and $104,000, respectively, compared to $30,000 and $197,000 in 2024. Gross margin was 67% in the six months ended June 30, 2025, compared to 42% in 2024. Operating expenses in the three and six months ended June 30, 2025 was $2.0 million and $3.5 million, respectively, compared to $1.3 million and $3.0 million in 2024. The increases were primarily due to the addition of the biopharma programs in February 2025. Net loss of $1.9 million for the three months ended June 30, 2025, compared to $1.3 million in the second quarter of 2024. Net loss of $3.4 million for the first half of 2025, compared to $2.7 million for the first half of 2024. At June 30, 2025, cash and cash equivalents totaled $1.2 million, compared with $2.0 million, at December 31, 2024. Subsequent to quarter's end, the Company raised a total of $0.9 million through utilization of its equity line of credit and the sale of Series B Preferred Stock pursuant to its preferred equity purchase agreement. The company has no debt on its balance sheet. Approximately $7.0 million remains available as a committed investment in Tivic through a preferred equity purchase agreement. The company believes the current and committed funding is sufficient to make meaningful progress toward manufacturing validation for Entolimod. Conference Call and Webcast Information Management will host a webcast/conference call today, Thursday, August 14, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the company's second quarter 2025 financial results and provide a business update. Webcast Link An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at About Tivic Tivic's dual platform utilizes the body's biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system. Tivic's biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track designation and is in late stage development. Tivic's bioelectronic program is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic's approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: Forward-Looking Statements This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will,' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of interactions with and guidance from the FDA and other regulatory authorities; changes to the company's relationship with the its partners; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading 'Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. Tivic Health Systems, Inc. Condensed Statements of Operations (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 REVENUES $ 86 $ 140 $ 156 $ 474 COST OF SALES 32 110 52 277 GROSS PROFIT 54 30 104 197 OPERATING EXPENSES Research and development 655 302 990 558 Sales and marketing 426 207 605 712 General and administrative 907 787 1,949 1,674 TOTAL OPERATING EXPENSES 1,988 1,296 3,544 2,944 NET OPERATING LOSS (1,934 ) (1,266 ) (3,440 ) (2,747 ) OTHER INCOME, NET 3 0 7 0 NET LOSS $ (1,931 ) $ (1,266 ) $ (3,433 ) $ (2,747 ) NET LOSS PER SHARE - BASIC AND DILUTED $ (2.19 ) $ (5.37 ) $ (4.64 ) $ (17.05 ) WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED 881,294 235,868 739,618 161,103 Expand

Industry Leader in Lyophilization, Dr. Serguei Tchessalov, Partners with BioTechnique ® to Enhance Customer Capabilities
Industry Leader in Lyophilization, Dr. Serguei Tchessalov, Partners with BioTechnique ® to Enhance Customer Capabilities

Business Wire

time3 days ago

  • Business Wire

Industry Leader in Lyophilization, Dr. Serguei Tchessalov, Partners with BioTechnique ® to Enhance Customer Capabilities

YORK, Pa.--(BUSINESS WIRE)--BioTechnique ® LLC ('BioTechnique' or the 'Company') proudly welcomes Dr. Serguei Tchessalov, a globally recognized subject matter expert in lyophilization, whose decades of experience in formulation development, process design, and scale-up bring invaluable insight to clients navigating complex biologic and vaccine manufacturing. With over 40 years of experience spanning both Russia and the United States, Dr. Tchessalov brings deep expertise in the formulation and freeze-drying of bacterial, viral, and mRNA-based vaccines, proteins, and other complex biologics. He holds a Ph.D. in Biotechnology Engineering from the Institute of Applied Biochemistry in Moscow, where his research focused on novel formulation and process control methods for lyophilization. After completing postdoctoral training with Professor Michael Pikal at the University of Connecticut, he went on to hold roles at Immunex, Wyeth, and Pfizer, contributing to industry-leading development efforts. Dr. Tchessalov is the founder of SN Lyophilization, a consulting firm dedicated to freeze-drying and parenteral drug product processing. With over 30 scientific publications to his name, his current work focuses on lyophilization scale-up and transfer, as well as processing operations including filtration, filling, freezing, and thawing. His partnership with BioTechnique strengthens the company's ability to support clients with practical, science-driven solutions across the entire drug product lifecycle. BioTechnique ® 's Lyophilization Capabilities At BioTechnique ®, lyophilization is a core competency backed by robust infrastructure and scientific expertise. Our state-of-the-art, aseptic manufacturing facility is equipped to support both clinical and commercial-scale freeze-drying of biologics, including monoclonal antibodies, peptides, vaccines, and other sensitive drug products. We offer flexible lyophilizer configurations, precise cycle development, and seamless tech transfer—all executed under strict cGMP conditions. Whether clients require formulation support, cycle optimization, troubleshooting, or full-process development, BioTechnique provides tailored solutions that prioritize product stability, yield, and regulatory compliance. With Dr. Tchessalov's guidance, our clients gain not only access to advanced modeling tools and industry best practices, but also the strategic insight needed to successfully navigate the complexities of lyophilization from early development through commercialization. For more information on BioTechnique's capabilities, visit

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