Syngene International Ltd.

Pictured: Biopharma items with cyber accents/Taylor Tieden for BioSpace China-based contract manufacturer WuXi AppTec has been the focal point of scrutiny from Congress for months. A House bill, the BIOSECURE Act, has labeled it a “company of concern” due to its alleged ties to the Chinese government and potential threat to U.S. national security. However, multiple biopharma companies depend on WuXi for critical research, development and manufacturing. The prospect of restricting WuXi’s vast scope of work has caused uncertainty in the market, but it has also opened the door potentially for some competitors to help fill the gap. Gil Roth, president of the Pharma & Biopharma Outsourcing Association, told BioSpace that the fallout from the BIOSECURE Act could be “very significant” for both contract development and manufacturing organizations (CDMOs) and customers. If the bill is passed in its current form, it could “create a dynamic environment if . . . customers need to find other contract service providers,” Roth said. A recent GlobalData report found the BIOSECURE Act could affect more than 120 U.S. biopharma drugs partnered with Chinese companies “of concern” named in the bill, of which about half are in clinical trials and a third are in early-stage preclinical studies and discovery. Thus, replacing the critical services provided by WuXi AppTec and others to American companies will be no small feat, especially as U.S. drug shortages are now at an all-time high. But the volume of business the U.S. biopharma sector is currently providing Chinese CDMOs could be a lucrative win for other contract manufacturers--especially those in India. Pushpa Vijayaraghavan, director of healthcare and life sciences at consulting firm Sathguru, told BioSpace in an email that Indian CDMOs have been trying to get a larger share of the U.S. market over the past few years. “The most recent wave of developments around WuXi could turn the tide,” Vijayaraghavan said. “Their approach has been multi-pronged—increased commercial thrust, clear inorganic focus on bridging capability gaps, organic capacity expansion, developing pilot capacity closer to the customer and deepening expertise in areas where demand is likely to expand.” Strong U.S. Ties In May 2024, the House Committee on Oversight and Accountability voted overwhelmingly to approve a new draft of the BIOSECURE Act, which sets a Jan. 1, 2032, deadline for U.S. drugmakers to cut their ties with WuXi AppTec, WuXi Biologics and other Chinese biotech companies. The draft also bans entering into new agreements—or extending or renewing existing contracts—with these Chinese companies or to farm out these contracts to other potential partners. The initial bill named four companies of concern: WuXi AppTec, Beijing Genomics Institute, Complete Genomics and MGI. The latest draft has been amended to explicitly identify WuXi Biologics. While it remains unclear whether the BIOSECURE Act will become law in its present form, it was hit with a legislative setback earlier this month when the House Rules Committee left the bill out of the final list of amendments to be discussed for inclusion in the National Defense Authorization Act for Fiscal Year 2025. The bill aims to ensure that taxpayer money isn’t going to fund biotech-aligned companies that can threaten national security. Specifically, the legislation would prohibit federal contracting with companies tied to “foreign adversaries,” including WuXi AppTec and other Chinese companies. If the act becomes law, it will prevent biopharma companies with contracts with these companies of concern from obtaining U.S. government contracts. WuXi has built a large presence in the U.S. with more than a dozen facilities handling everything from molecular screening to manufacturing. The company is expanding its U.S. presence, notably with a new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware. WuXi is “heavily embedded in the U.S. medicine chest, making some or all of the main ingredients for multibillion-dollar therapies that are highly sought to treat cancers like some types of leukemia and lymphoma as well as obesity and HIV,” according to The New York Times, which cited one estimate that the Chinese CDMO has been involved in developing one-fourth of the drugs used in this country. Bikash Chatterjee, president and chief science officer of consulting firm Pharmatech Associates, agreed that Wuxi is entangled with U.S. biopharma. “Banning them would have a significant impact on any organization with development programs funded through government grants or if they plan to engage the government as a customer for their product,” Chatterjee told BioSpace in an email. “Given the high cost of investment and debt financing, the cost to change development partners midstream would likely force drug sponsors to make some difficult decisions regarding which assets in their portfolios to develop.” At the same time, recent reporting from Reuters alleges that WuXi AppTec shared the data of a U.S.-based client with the Chinese government without the client’s consent, which may have given biotech companies additional incentives to break ties with Chinese biotechs. “If I’m a venture investor or a shareholder in an emerging pharma-biotech, and even a Big Pharma company, and my government is citing examples of information sharing with specific companies that happen to be Chinese owned, it is concerning and it’s hard to overlook,” Brian Scanlan, partner at Edgewater Capital Partners, told BioSpace. CDMO Prospects in India Who will capitalize on the opportunity if there are any shifts away from WuXi and other Chinese companies? Scanlan noted that to fit the needs of U.S.-based customers, there must be enough infrastructure that can absorb the number of clients and offer competitive costs for services. Across the Himalayas from China, a sizable CDMO industry has been establishing itself in India over the past few decades. According to market intelligence company Mordor Intelligence, the contract manufacturing market in India is estimated to be over $22 billion and may top $44 billion by 2029, with a growth rate of 14%. The country is already a source of generic pharmaceutical production, key starting materials, active pharmaceutical ingredients and other products. The Indian government is also looking to actively invest in the pharma industry with, investments of over $37 billion between 2022 and 2027 planned, according to Mordor Intelligence. WuXi’s problems with Congress are a potential opportunity for Indian contract manufacturers to make inroads in the U.S. market. Vijayaraghavan said that Indian CDMOs have been engaged in investment to build up production capacity and other capabilities. However, she said these companies will need to ramp up the pace of these investments “in areas where demand could soon exceed supply” if WuXi’s business is impacted. If Indian CDMOs attempt to bid for WuXi’s U.S. business, Vijayaraghavan noted that creating inroads in this market involves “long gestation periods” and—if the capacity cannot meet demand—other global CDMOs may step in and grab the business in the short term. Charles Achibiri, CEO of CDMO and CMO review site SciRank, told BioSpace that Indian contract manufacturers might not be ready to produce small molecules and noted that Indian CDMOs are also “plagued” by quality issues. “Indian CDMOs such as Cipla, Syngene, and Aurobindo may be well-positioned for increased growth due to their cost-effectiveness and highly skilled workforce,” Alison Labya, business fundamentals analyst at GlobalData, said in a statement. “However, growing concerns of US dependency on offshore suppliers may also result in a shift towards US companies selecting domestic CDMOs.” Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

DUBLIN, March 29, 2024 /PRNewswire/ -- The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023" report has been added to ResearchAndMarkets.com's offering. MSCs appear to be an exceptionally promising tool for cell therapy, because of their unusual advantages, which include availability, expandability, transplantability, and ethical implications. Interest in therapeutic applications of human MSCs arises from their diverse ability to impact human health, as well as their ability to migrate to sites of tissue injury/inflammation or tumor growth. MSCs are essential raw materials for many regenerative medicine products, including cell-based therapies, engineered tissues, exosome products, cosmeceuticals, and cultured meat production. MSCs are also well-suited for use in the exponential growth field of 3D printing and numerous companies are working on manufacturing technologies to support the commercial-scale production of MSCs. Today, numerous market competitors are also exploring commercialization strategies for MSC-derived extracellular vesicles (EVs) and exosomes, because these extracellular "packages" represent a novel strategy for accessing the therapeutic effects of MSCs without the risks of administering whole cells to patients. Gene editing of MSCs for overexpressing antitumor genes or therapeutic factors is broadening their application as well. Despite the challenges associated with commercializing MSC-based therapeutics, there are more than 100,000 scientific publications published about MSCs and over 1,100 MSC-based clinical trials underway worldwide. Clinical trials involving MSC therapeutics have risen in recent years, in part due to trials related to COVID-19. Current "hotspots" for MSC clinical trials include the U.S., E.U., China, Middle East, and South Korea. While many early-stage MSC trials have demonstrated safety and efficacy, only a small number of MSC products have reached commercialization, indicating that the therapeutic market for MSCs remains early-stage. The first MSC-based cell therapy product was approved in 2010 in South Korea. To date, ten MSC-based cell therapy products have gained approval, as well as 19 MSC-based bone matrices. While therapeutic success has been challenging, the demand for MSC-based research products has surged in recent years, with most large research product suppliers now offering a variety of MSC-based products, services, kits, and manufacturing tools. Major players involved in the market for MSC-based research products include Lonza, Thermo Fisher Scientific, Sigma Aldrich, VWR, Sartorius, ATCC, EMD Millipore, and others. Smaller and mid-sized players are also competing in this promising market, including but not limited to Axol Bioscience, StemBioSys, PromoCell, and iXCell Biotechnologies. To date, the company to establish itself with the greatest domain knowledge in the area of MSC-based products and manufacturing technologies is RoosterBio, headquartered in Frederick, Maryland, USA. Cynata Therapeutics is also working diligently on technologies to enable large-scale production of MSC-based therapeutics, although it is exclusively focused on MSC-based therapeutics and is using its CymerusT platform technology to produce nearly infinite numbers of iPSC-derived MSCs. It is concurrently pursuing several clinical trials worldwide. In the coming years, an increasing number of research products and therapeutic products will continue to be developed around MSCs and their differentiated cell types. Within this rapidly changing landscape, having a thorough understanding of the competition is essential. Therefore, this global strategic report details the activities of 113 leading MSC companies, including their core technologies and products under development. It presents detailed market size figures for the global MSC market, segmented by Geography and Business Segment, and accompanied by future forecasts through 2030. This global strategic report includes: Market size determination for the global MSC market, segmented by Geography and Business Segment Future forecasts for the Global MSC Market through 2030 Major diseases addressed by MSCs in the ongoing clinical trials Cost of manufacturing autologous and allogeneic MSCs Rates, quantities, geographic locations, and types of MSC clinical trials Types and sources of MSC industry funding Detailed MSC patent analysis, including rates and geographic breakdown of MSC patents The top owners, inventors, and sponsors of MSC patents Recent business developments related to MSCs, including strategic collaborations and partnerships MSC-based products with marketing approval and the companies commercializing them Currently marketed MSC-based bone matrices Pricing comparison of MSC-based products with marketing approval The pipeline for MSC-based therapeutics Emerging applications for MSCs, including genetic modification, 3D bioprinting, clean meat production, and cosmeceuticals Company profiles for MSC market competitors, including their products, services, and technologies under development Dozens of charts, figures, and tables And so much more In summary, this global strategic report presents market size figures with forecasts through 2030, as well as rates of MSC clinical trials, scientific publications, patents, funding events, and strategic collaborations. It also presents the pipeline for MSC-based therapeutics, identifies leading market competitors, and explores future directions for the industry at large. With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities. Key Topics Covered: 1. REPORT OVERVIEW 2. MESENCHYMAL STEM CELLS (MSCS): AN OVERVIEW 3. PUBLISHED SCIENTIFIC PAPERS ON MSCS 4. STEM CELLS PATENT LANDSCAPE: AN OVERVIEW 4.1 Geographical Distribution of Stem Cell Patent Filing 4.2 MSC Patents 5. MSCS: CLINICAL TRIAL LANDSCAPE 5.1 Analysis of Data from ClinicalTrials.gov 5.2 Administration of MSCs in Clinical Trials 5.3 MSC Clinical Trials by Disease Category 6. BIOENGINEERING SOLUTIONS TO BOOST MSC'S FUNCTIONS 6.1 Small-Molecule Priming 6.2 Particle Engineering 6.3 Genetic Engineering 6.4 Bioengineering Approaches to Improve MSC Administration 7. MANUFACTURING OF MSCS 7.1 Autologous and Allogeneic MSCs 7.2 Methods of Isolation of MSCs 7.3 Cell Expansion: Conventional Cultures to Bioreactors 7.4 Bioreactors in Current Use 7.5 Main Features of Commercial Bioreactors 7.6 Number of Cells per Batch by Technologies 7.7 Microcarriers for the Expansion of MSCs 7.8 Downstream Processing of MSCs 7.9 Autologous & Allogeneic MSC Manufacturing: A Comparison 7.10 Cost Breakdown in MSC Manufacturing 8. SMALL SCALE PROCESSING OF MSCS 8.1 Model Design 8.2 Culture Media 9. LARGE-SCALE MANUFACTURING OF MSCS 9.1 The Four Common Bioprocessing Strategies for Large-Scale Expansion of MSCs 9.2 Commonly Used Sources of MSCs for Large-Scale Expansion 9.3 Commonly used Culture Media for Large-Scale Expansion of MSCs 9.3.1 Expansion Ratios Achieved with Different Culture Media 9.4 Comparison between the Four Large-Scale MSC Expansion Strategies 10. CONTRACT MANUFACTURING FOR CELL & GENE THERAPIES 10.1 The Need for Staff with Expertise 10.2 Capacity Constraints 10.3 CDMO Platforms Showing Greatest Growth Potential 10.4 Outsourcing Trends for Cell & Gene Therapies (CGT) 10.5 CMOs/CDMOs 10.6 Global Bioprocessing Capacity 10.7 Top Global CDMOs in 2022 10.8 U.K.'s Domination in European Cell & Gene Therapy Contract Manufacturing 11. MAJOR DISEASES ADDRESSED BY MSCS 12. CURRENT STATUS OF MESENCHYMAL STEM CELL INDUSTRY 12.1 Brief Account of Modified MSCs 12.2 MSC-Based Products with Marketing Approval 12.3 Currently Marketed MSC-Based Bone Matrices 13. RECENT COLLABORATIONS IN MSC SECTOR 14. MARKET ANALYSIS 14.1 Price Tags of MSC-Based CT Treatment 14.2 Price Tags of MSC-Based Matrices 14.3 Market Size of MSC-Based Therapies 14.4 Global Market for MSC-Based Therapeutics 14.5 Global Demand for Mesenchymal Stem Cells (MSCs) 15. COMPANY PROFILES 101 Bio AGC Biologics AMS Biotechnology AQ Skin Solutions AbbVie Abzena Adipomics Advancells Advent Bio Aegle Therapeutics Aethlon Medical AgeX Therapeutics AlloSource Ambulero American CryoStem Corporation American Type Culture Collection (ATCC) Andelyn Biosciences Anemocyte Anterogen Arranta Bio Aruna Bio Avid Bioservices Bacthera Baylx, Inc. Bio-Techne BioCardia BioCentriq BioEden, Inc. BioRestorative Therapies Bioinova Bioscience Institute Blue Horizon International Boehringer Ingelheim BioXcellence Bonus Biogroup, Ltd. BrainStorm Cell Therapeutics CCRM CardioCell, LLC Caregen Nordic Catalent Pharma Solutions CellResearch Cellipont Bioservices Celltex Therapeutics Cellular Biomedicine Group Celprogen, Inc. Charles River Laboratories International, Inc. Citius Pharmaceuticals, Inc. Corestem, Inc. Creative Bioarray Cynata Therapeutics, Ltd. Cytovance Biologics Dendreon Direct Biologics EXOSOMEplus ElevateBio Exothera FUJIFILM Cellular Dynamics Fujifilm Diosynth Biotechnologies Future Cell Japan Co., Ltd. Genezen Hope Biosciences Invitrx Therapeutics JCR Pharmaceuticals Just-Evotec Biologics Kimera Labs LifeCell Longeveron Lonza Group, Ltd. Lorem Cytori USA, Inc. Lykan Bioscience Matica Biotechnology, Inc. Medipost, Co., Ltd. Mesoblast, Ltd. MilliporeSigma NecstGen Novus Biologicals NuVasive Orthofix Medical Personal Cell Sciences Personalized Stem Cells Pluristem Therapeutics Porton Advanced PromoCell Regeneus Reliance Life Sciences Rentschler Biopharma Resilience Richter-HELM RoosterBio, Inc. RoslinCT STEMCELL Technologies, Inc. Samsung Biologics Sentien Biotechnologies, Inc. Smith & Nephew plc Stemedica Cell Technologies, Inc. Stemmatters Stempeutics Research Pvt. Ltd. Symbiosis Pharmaceutical Syngene International Ltd. TaiwanBio Therapeutics Takeda Pharmaceutical Tempo Bioscience Thermo Fisher Scientific TranstoxBio VIVEbiotech Viralgen Waisman Biomanufacturing WuXi Biologics Yapan Bio Yposkesi Zimmer Biomet Holdings For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024. The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing. The drug substance capacity includes two production suites with five 2KL single use bioreactors each, for a total capacity of 20KL. The facility also includes two high-speed vial filling lines capable of producing up to 1 million vials per day ranging from 1 to 100mL fill volumes. In addition to the production capacity, the site has a development suite for clinical supply of drug substance equipped with a 500L single use bioreactor. The facility triples Syngene's bio manufacturing capacity and adds to its existing commercial manufacturing site in Bangalore, India – BMP 1 – which has been approved by the US FDA (with no 483 observations) and EMA, as well as a PROTAC research site in Hyderabad, India. Syngene has further expansion plans for two additional vial filling isolator lines with capacity for 600 vials/minute and 100 vials/minute respectively and drug substance expansion into perfusion cell culture processing. "We see interest not only from existing partners looking to move innovative biologics into clinical and commercial manufacturing, but also from new biotechs and big pharma companies. In particular, there is demand from commercial clients looking for immediately available capacity. With US FDA and EMA approvals in place, Unit 3 is a very attractive option, so we are preparing for a busy week at DCAT," commented Jonathan Hunt, MD & CEO, Syngene International Ltd. The $98m[1] manufacturing site is integrated with other biologics capabilities in the city including around 170 R&D scientists located nearby offering clients a seamless transition from discovery biology services into clinical and commercial manufacturing. The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients. Alex Del Priore, Senior Vice President – Manufacturing Services, Syngene International Ltd. added: "Unit 3 provides the capacity to support our customers' growth and will become our flagship location for both our core business and the emerging growth areas in ADCs or cell and gene therapy. The site is integrated with nearby R&D, drug substance and drug product capabilities to improve our time to clinical trials and reduce cost per gram." Downstream processing is supported by chromatography systems with capacity of 600 to 2000 LPH enabling the purification and isolation of target molecules from complex mixtures. The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing. Additionally, to meet the growing demand for protein concentration and diafiltration, Syngene has invested in automated tangential flow filtration (TFF) systems to facilitate the concentration and diafiltration of biologics, maximizing the yield and quality of final products, as well supporting perfusion manufacturing. In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions. Notes to editors About Syngene Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene's more than 6000 scientists offer both skills and the capacity to deliver great science, robust data security, and world class manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, and Bristol-Myers Squibb as well as 2 Mn sq. ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading-edge science as well as multinationals, including GSK, Zoetis and Merck KGaA. For more details, visit . For the Company's latest Environmental, Social, and Governance (ESG)report, visit . [1] SOURCE Syngene biologics