Curida, Small Molecules and Biologics CDMO, Secures Private Equity Investment from Signet Healthcare Partners

Integrated provider of drug development and manufacturing services to leverage Signet’s pharma services expertise for business growth.

OSLO, NORWAY – Curida Holding AS (“Curida”) has announced a significant growth investment from Signet Healthcare Partners (“Signet”), a New York-based healthcare private equity firm. This strategic partnership will enable Curida to accelerate its expansion plans, including enhancing facility capabilities and growing its industry position.

Established in 2015 and headquartered in Oslo, Norway, Curida is an integrated Contract Development and Manufacturing Organization (“CDMO”) specializing in the use of blow-fill-seal (“BFS”) and nasal spray technologies, as well as antibody manufacturing. Curida provides outsourced development and manufacturing of aseptic and non-aseptic liquid BFS and nasal spray formatted drugs, and serves the diagnostics industry with monoclonal antibodies. Curida’s customer base ranges from small to medium-sized pharmaceutical and biotech companies, delivering solutions in drug development and GMP manufacturing globally.

In conjunction with Signet’s investment, Signet is joining the Board of Directors, and Ole J. Dahlberg has been appointed as Chairman of the Board. Dahlberg has more than 20 years of experience from ledership roles in the life science market and is former Vice President & General Manager at Thermo Fisher Scientific in California, USA. Dahlberg stated, “We are very pleased to welcome Signet as a significant shareholder in Curida. Signet brings strong relevant industry experience and a track record of CDMO investing. Signet is co-investing alongside Curida’s existing shareholders Canica, Investinor, Klaveness, and Farvatn. We are excited by the opportunity to further accelerate innovation and advance productivity for our pharma and biotech customers in their work to deliver medicines and therapeutics to benefit patients. On behalf of the board, I want to thank Per Thoresen, who has been acting Chairman of the Board and for his valuable contributions to Curida over the past 9 years.”

Additionally, the Board has appointed Anders Larsson, the Company’s Chief Operating Officer, as Chief Executive Officer, effective May 1st, 2024. Larsson comes with extensive experience in management, operations, and strategic development from the pharma industry. His former roles include CEO of Boots Pharmacy/Alliance Healthcare in Norway (Cencora). In addition, Larsson has experience from various roles in the food & beverage industry with Orkla and Carlsberg. Larsson holds an MSc in Chemical Engineering from Chalmers University and Imperial College and a BSc in Finance from Gothenburg University.

Signet Managing Director Nikhil Puri said, “We are proud to partner with Curida and support their robust growth strategy. The Company’s strong values, commitment to excellence, and strategic vision align nicely with our investment philosophy. We look forward to contributing to Curida’s success in the coming years. We were attracted to Curida due to its strong, differentiated manufacturing capabilities, customer-centric approach, and management team strength. We see a strong opportunity for Signet to leverage its network and prior CDMO investment experience to accelerate growth.”

DNB Markets served as financial advisor, and Advokatfirmaet Simonsen Vogt Wiig served as legal advisor to Curida. Sheppard, Mullin, Richter & Hampton LLP and Advokatfirmaet Selmer served as legal advisors to Signet. Terms of the transaction were not disclosed.

About Curida Group

Curida offers contract development and manufacturing solutions to European pharmaceutical and biotech companies globally. Curida focuses on aseptic and non-aseptic liquid manufacturing and specializes in blow-fill-seal (“BFS”) and nasal spray technologies to serve the Small Molecules pharmaceutical and medical device market. For biologics, Curida offers upstream- and downstream processing of monoclonal antibodies for in-vitro diagnostics (“IVD”). For more information, visit www.curida.no

About Signet Healthcare Partners

Headquartered in New York, NY, Signet is an established provider of growth capital to innovative healthcare companies. SIGNET invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm invests primarily in pharmaceutical and medical device companies. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 25-year history, the firm has developed a strong reputation and track record of successful healthcare investments. Signet has raised funds with total capital commitments of over $600 million and has invested in more than 55 companies. For more information, visit www.signethealthcarepartners.com.

Contacts

Curida Holding AS
post@curida.no

Audrey Liu
Signet Healthcare Partners
audrey.liu@signethp.com

Breakthrough Cardiac Study Reveals Long-Term Impact on Post-Transplant Survival: A 2-Year Clinical Investigation Advancing Heart Preservation

Investigators present statistically significant 24-month outcomes of transplant recipients with donor hearts preserved by the Paragonix SherpaPak Cardiac Transport System – a record-first advancement in long-term care empowered by controlled hypothermic preservation technology.

WALTHAM, MA. April 12, 2024 - Paragonix Technologies, Inc., a pioneer in organ transplant technologies and services, announces the annual release of the latest GUARDIAN-Heart Clinical Registry report, shared earlier today at the 44th ISHLT Annual Meeting and Scientific Sessions – one of the largest international conferences focused on advanced treatment for end-stage heart and lung disease. Notably, the unprecedented study represents the first time any medical device technology has ever demonstrated statistically significant improvements in 2-year survival following heart transplantation.

The analysis consisted of a total of 1,261 US adult patients, which were matched using statistical propensity matching to create two cohorts of equal baseline characteristics to compare the use of the SherpaPak® System against traditional ice storage. The matched cohorts consisted of 362 patients each. Investigators reported statistically significant improvements associated with utilizing the Paragonix SherpaPak System including:

•        5% increase in 2-year survival, which represents a 43% reduction in 2-year mortality – a technological milestone in heart transplantation.

•        50% reduction in Severe Primary Graft Dysfunction, defined as the use of Mechanical Circulatory Support (MCS), excluding balloon pumps, within 24 hours post-transplant.

•        32% reduction in all post-transplant MCS, including MCS continued from pre-transplant throughout the post-transplant period.

•        39% reduction in New Extracorporeal Membrane Oxygenation (ECMO)/Ventricular Assist Devices (VAD) post-transplant, including MCS use from transplant through discharge (both primary [<24 hours] and secondary
[> 24 hours] graft dysfunction).

•        44% reduction in Severe Right Ventricular Dysfunction (RVD).

“This breakthrough is game-changing," said Dr. Scott Silvestry, a lead investigator and renowned cardiac surgeon with decades of clinical experience. "Previously when we started using SherpaPak, we were impressed how the donor hearts felt pliable and performed better immediately. Now, with evidence of superior survival 2 years after surgery, the average number of transplants required for a transplant center to see an impact on the survival of their patients is only 22 procedures. We are now talking about saving lives and any given program can save 1-5 lives per year in the survival difference alone.”

The study concluded that these advantages are increasingly important in an era of longer procurement distances with longer ischemic times occurring in contemporary heart transplantation.

“For as long as heart transplant has been a discipline, we have been racing against the clock,” said Dr. David D’Alessandro, a lead investigator and Surgical Director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital. “This study indicates that the SherpaPak System can attenuate the risks of ischemic time through controlled hypothermic and isobaric preservation. Our findings showed that hearts performed better in a SherpaPak than on ice across all examined ischemic timeframes – whether it’s simply one hour or very long-distance procurements.”

Paragonix is committed to working closely with transplant centers, organ procurement organizations, and healthcare professionals to ensure broad accessibility of its Advanced Organ Preservation technology, including the Paragonix SherpaPak System, which is utilized across over 130 programs globally to preserve and protect donor hearts.

L-603 Ver. 0

Paragonix Technologies Receives FDA Clearance for BAROguard™ Donor Lung Preservation System

Leading organ preservation company receives FDA clearance for its next generation donor lung preservation system, designed for automated active lung pressure and temperature management during critical donor lung transportation

August 24, 2023 09:00 AM Eastern Daylight Time

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard™. The BAROguard™ System combines Paragonix’s existing advanced hypothermic preservation technology with automated continuous and active airway pressure control, ensuring that an optimal temperature range and a clinically recommended inflation pressure range for donor lungs are maintained throughout the journey from donor to recipient patient. This novel combination of advanced technologies further reinforces the company's ongoing commitment to improve and redefine the standard of care within transplant medicine.

Under current clinical practice, donor lungs are preserved and transported in an inflated state from donor to recipient site. However, current organ recovery techniques do not reliably maintain and control lung inflation pressures within the clinically recommended range of 12-15 cmH2O. Notably, most donor lungs are transported via aircraft, where ambient pressure changes may expose lungs to reach elevated pressure, which has been demonstrated in respiratory management studies to increase the risk of pulmonary barotrauma.1-3 “The BAROguard Donor Lung Preservation System was designed to address these critical issues with an automated and easy to use active pressure management system,” said Dr. Lisa Anderson, CEO and President of Paragonix.

“Manually inflating donor lungs can be a highly variable process during lung donation. There is the belief that maintaining a consistent donor lung airway pressure can be useful for optimizing static preservation, especially when recovering organs over extended times or distances” said Dr. Jack Haney, Surgical Director, Lung Transplant Program from Duke Medical Center. “BAROguard offers the potential for significant advancement of lung preservation that we will be studying via the GUARDIAN registry.”

“At Paragonix, we believe that transplant surgeons should have maximum control over the organ transplant process. BAROguard now offers automated active control over donor lung airway pressures and automated donor lung temperature control, both of which are continuously reported out in real-time to the transplant team,” said Dr. Lisa Anderson, CEO and President of Paragonix. “The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”

For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

About Paragonix Technologies

Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation.

Paragonix Technologies provides Advanced Organ Preservation (“AOP”) devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.

Follow us on Twitter: @ParagonixSherpa
Connect with us on LinkedIn: Paragonix Technologies
Like Us on Facebook: Paragonix SherpaPak

L-487, Rev 0

References

1. Patel, M, et al. J Surg Res. 2005

2. Boussarsar, et al. Intensive Care Med. 2002

3. Esteban, et al. JAMA 2002

 Contacts

Media: Adam Lafreniere, Sr. Director, Marketing
marketing@paragonixtechnologies.com

Cell Microsystems Acquires Fluxion Biosciences

Positions the Company as a new leader in providing solutions that bridge the gap between cellular electrophysiology and advanced analysis techniques

DURHAM, NORTH CAROLINA, UNITED STATES, August 23, 2023, Research Triangle, NC – Cell Microsystems, a provider of pioneering solutions for cell biology research, is excited to announce the acquisition of Fluxion Biosciences, a leader in automated patch clamp technology and cell-based assay tools. This acquisition complements the Company’s platforms and applications based on the CellRaft technology, enhancing its offerings for researchers and life science professionals worldwide.

With the acquisition of Fluxion Biosciences and their IonFlux, BioFlux, and IsoFlux products, Cell Microsystems adds to its portfolio to form a suite of innovative cell analysis solutions. The product expansion will further leverage the cell line development and rare cellular event isolation capabilities of Cell Microsystems by providing unique cell lines and an expanded set of applications for use on the IonFlux and BioFlux instrumentation.

“Bringing the products and services of Fluxion Biosciences into Cell Microsystems is a leap forward for us,” stated Gary Pace, CEO of Cell Microsystems. “This combination aligns with our commitment to empower researchers with the most advanced tools for in-depth cell line development and cellular research that drives progress in the life sciences.”

The IonFlux automated patch clamp technology broadens Cell Microsystems’ offerings, positioning the Company as a new leader in providing solutions that bridge the gap between cellular electrophysiology and advanced analysis techniques. In addition, the BioFlux system for live cell assays under physiological conditions complements the real-time image-based phenotyping and 3-D biology expertise of Cell Microsystems, and IsoFlux enhances the CellRaft AIR System’s rare cell event capabilities. Overall, the combination of the Fluxion and Cell Microsystems product lines offers researchers the tools needed for critical insights into various physiological processes.

Jeff Jensen, formerly CEO of Fluxion Biosciences, and his team will join Cell Microsystems. “We are excited to merge our efforts with Cell Microsystems,” commented Jeff. “Our shared vision of advancing cellular analysis tools will push the boundaries of cell behavior understanding, ultimately contributing to advancements in disease research and drug discovery.”

The acquisition was supported by a concurrent Series B financing led by Telegraph Hill Partners. The financing also provides significant growth capital for the business to make groundbreaking advancements in tools for cellular analysis. “We are enthusiastic about our partnership with Cell Microsystems,” commented Deval Lashkari, Senior Partner at Telegraph Hill Partners. “The company’s dedication to advancing cellular analysis aligns with our investment strategy. We believe that Cell Microsystems is well poised to drive innovation and transform the field.”

For more information about products and technology from Cell Microsystems and Fluxion Biosciences, please visit www.cellmicrosystems.com and www.fluxionbio.com.

About Cell Microsystems:
Cell Microsystems’ lead products, the CellRaft AIR® System and CellRaft® Arrays, enable complex workflows to be performed on a single consumable, including clonal propagation of single cells for CRISPR gene editing, cell line development, stem cell studies, organoids, and other 3D cultures, cell-based assays, and genomics research. The System uses real-time on-array image analysis under standard culture conditions that enable single cells or clones to be independently isolated for additional culturing or downstream analysis. The System facilitates single cell workflows with unperturbed phenotypes, high viability, and efficient yields producing results with faster turnaround times for downstream analysis and richer datasets for discovery and translational research.

Lisa Birkby
Cell Microsystems, Inc.
+1 919-608-2035
lbirkby@cellmicrosystems.com

Signet Healthcare Partners Exits Investment in RK Pharma Inc.

NEW YORK, June 13, 2023 — Signet Healthcare Partners ("Signet") is pleased to announce the successful completion of the sale of its stake in RK Pharma Inc. ("RK Pharma") to PAG. RK Pharma, a leading developer, manufacturer, and distributor of high-quality, affordable generic pharmaceutical products, with a particular focus on complex injectables, operates a state-of-the-art Sterile Drug Product Manufacturing facility in Pearl River, NY. RK Pharma's group of companies includes subsidiaries Apicore, Archis Pharma, and Aktinos Pharma, which provide a rich supply of complex Active Pharmaceutical Ingredients (“APIs”) and Intermediates, as well as commercialization services.

As the first institutional investor in RK Pharma, Signet invested in the company in 2019. Under the exceptional leadership of Dr. Ravishanker Kovi and his executive management team, RK Pharma experienced tremendous growth, nearly quadrupling its revenue over the past four years while maintaining its position as an industry leader in drug manufacturing and development.

James Gale, Founder and Managing Director of Signet, commented, "We have thoroughly enjoyed our collaboration with RK Pharma over the past four years. Dr. Ravi and the executive management team have demonstrated their expertise and proven track record in pharmaceutical manufacturing and development and have been exceptional partners. Together, we have built a business of scale that remains dedicated to delivering high-quality and affordable generic products to patients worldwide. We hold great respect for the accomplishments of the RK Pharma team and eagerly anticipate their continued success in the years ahead."

Dr. Ravishanker Kovi added, "Partnering with Signet for the second time has been a rewarding experience. Signet’s growth capital funding into RK Pharma gave the impetus needed to accelerate revenue growth. Signet's extensive healthcare and investing expertise has played a vital role in our business growth and facilitating the successful transaction with PAG. We deeply appreciate Signet's unwavering support as a value-add partner throughout our journey."

Troutman Pepper Hamilton Sanders LLP acted as legal counsel to Signet. Sheppard, Mullin, Richter, and Hampton LLP acted as legal counsel to RK Pharma Inc.

About Signet Healthcare Partners

Signet Healthcare Partners is a leading provider of growth capital to innovative healthcare companies, specializing in pharmaceutical and medical device sectors. The firm maintains a disciplined, yet flexible investment approach and collaborates closely with its portfolio companies to enhance value. With a proven track record of successful investments over its 25-year history, Signet has raised cumulative capital commitments exceeding $600 million and invested in over 55 companies. For more information, visit www.signethealthcarepartners.com

Juno Pharmaceuticals Acquires Omega Laboratories, Propelling Canada’s Pharmaceutical Industry Forward

Juno will bring a much-needed expanded offering of critical pharmaceuticals to Canada, by investing in domestic production

TORONTO--(BUSINESS WIRE)--Today, Juno Pharmaceuticals Canada (“Juno”), a leader in the commercialization of specialty pharmaceuticals, announced the acquisition of Omega Laboratories (“Omega”), one of Canada’s largest domestic specialty injectable pharmaceutical manufacturers. The new combined company is now one of the largest specialty generic injectable businesses in Canada with domestic manufacturing capabilities.

“We are proud of this acquisition that solidifies Juno’s ability to improve drug supply with medications that are critically needed to support our healthcare system,” said Mark Mantel, CEO of Juno. “We are Canadian owned and operated and will continue to support our domestic market while expanding into new geographies with dependable and high-quality Canadian-made pharmaceuticals.”

Powered by Omega’s recently opened Health Canada and U.S. FDA approved injectable manufacturing facility and strengthened by Juno’s robust commercial network and product development pipeline, Juno will quickly bring an expanded array of critical pharmaceutical products to life and into the hands of medical practitioners and patients. Over the next four years, Juno expects to bring over 100 new products to the Canadian market with key expansions in pain management, oral solutions, allergy vaccines, diabetes & weight-loss and in addition, launch unique offerings in the dental, cosmetic, and animal health sectors.

This partnership comes at a critical time as Canada’s vulnerability to the global market continues to have repercussions for efficiency and access to critical pharmaceuticals, as supply channels remain pinched post-pandemic. By bolstering domestic manufacturing capabilities, Juno will aid in bringing stability to Canada’s healthcare system while providing immediate relief for many of the drug shortages presently facing patients, as well as preventing future shortages.

“Combining Omega’s manufacturing expertise and Juno’s commercial strength, we are creating a formidable player within Canada’s pharmaceutical industry, with plans to expand our reach into other markets with our high-quality medications,” said Bruce Levins, COO of Juno. “We are committed to serving Canadians by investing in domestic production, protecting and adding local jobs and creating a system of self-sufficiency when it comes to our domestic pharmaceutical market.”

Juno plans to bring multiple new products to Canada, establishing itself as the fastest-growing domestic specialty pharmaceutical business.

Bloom Burton Securities Inc. served as financial advisor and Aird & Berlis LLP acted as legal counsel to Juno in connection to the acquisition.

About Juno Pharmaceuticals Canada

Juno Pharmaceuticals Canada specializes in manufacturing, developing, and delivering high-quality, cost-effective, complex, and high value generic, branded and biosimilar products. With operations in Toronto and Montreal, Juno is one of the largest generic injectable businesses in Canada with domestic manufacturing capabilities and a robust distribution pipeline throughout 22 international markets. An early member of the global Juno Pharmaceuticals group, Juno’s global operations span four continents and consist of over 14 diverse pharmaceutical and medical device businesses spread across Canada, the United Kingdom, the European Union, Australia, and South Africa.

Contacts

Media

Maxine Bullock

Maxine.Bullock@kaiserpartners.com

647.460.5990

Goodwin Biotechnology Inc. (GBI) Announces First Commercial Contract Signing

PLANTATION, Fla., April 4, 2023 /PRNewswire/ -- GBI proudly announces the signing of their first Master Supply Agreement for commercializing an antibody. With the development of this new partnership, GBI's integrated CDMO biologics services will showcase their expertise in bringing a product from clinical trials through commercial supply while providing manufacturing of both Drug Substance and Drug Products. "This is a major milestone in our journey and a validation of the efforts our team has put into evolving GBI, and this is only the next step of many more exciting accomplishments as we continue our evolution," says CEO Darrin Schellin.

In conjunction with their exhilarating work in bringing life-altering therapies to the market with their partners, GBI is looking forward to expanding its horizons and has set new milestones with this new partnership. Karl Pinto, Chairman of the Board at GBI commented, "We have always invested and grown while supporting our clients' success, and this Agreement is a testament to the partnership we have built over many years with this key client. There are more to come!". Congratulations GBI.

About GBI

GBI is a uniquely qualified and flexible US–based CDMO (contract development and manufacturing organization) that offers a Single Source Solution™ to enhance the value of complex biopharmaceuticals for our clients. With 30 years of experience as an independent contract manufacturer, GBI has worked as a strategic partner with companies and institutions of all sizes, taking their products through clinical trials and towards rapid commercialization. GBI provides process development and cGMP manufacturing services encompassing drug substances and drug products for complex biologics, including multi-specific antibodies, recombinant proteins, antibody-drug conjugates, and other cell-based products.

For more information, please visit https://www.gbibio.com/

or

Contact: info@gbibio.com

GBI
1850 N.W. 69th Avenue
Plantation, FL 33313
Phone: 954-321-5300
Fax: 954-587-6378
info@gbibio.com 

SOURCE GBI

Paragonix Technologies Raises $24M in Series B Led by Signet Healthcare Partners

Leader in organ transplant technologies secures institutional growth capital to drive organ preservation innovation and commercial expansion

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc., a leading organ transplant company, today announced that it has secured $24 million in Series B funding, led by Signet Healthcare Partners. This growth investment will bolster Paragonix Technologies’ commercial footprint, including its ongoing extension of clinical service offerings and inventory expansion, and will enable the Company to further advance transplant innovations.

Paragonix Technologies, a leading developer and manufacturer in the organ transplant industry, offers three FDA-cleared and CE-marked devices: Paragonix SherpaPak®, LUNGguard™ Donor Lung Preservation System, and the LIVERguard™ System. All three devices utilize first-of-its-kind preservation methods that present a significant improvement over traditional ice and cooler practices still used today. Paragonix devices combine clinically-proven, stable preservation technology with a comprehensive clinical support network, augmented by the largest clinical registries of organ preservation data worldwide. They also incorporate digital tracking and communication technologies to provide complete control over organ tracking, monitoring, and reporting.

“The future of Paragonix is full of promise and excitement. Our focus remains on creating the best possible product to help more people receive a second chance at life in a safe and effective manner,” said Dr. Lisa Anderson, CEO of Paragonix Technologies. “This growth investment arrives at a critical moment as we strive to meet rising demands for our organ preservation products. We are excited to rapidly advance our innovation pipeline to enhance our ability to safely preserve and transport as many donor organs as possible. We are thrilled to have Signet as our partner in accelerating growth and achieving our ambitious long-term strategic objectives, and we look forward to leveraging their vast experience in the medical device market.”

Ashley Friedman, Managing Director at Signet Healthcare Partners, stated, "At Signet, we seek to invest in highly innovative and fast-growing healthcare companies. Paragonix has rapidly become a leader in the organ transplant market and is having a significant impact on the future of transplant medicine. We are impressed by their commercial and clinical achievements to date and are excited to partner with their dedicated and versatile team during the next phase of growth."

In 2022, over 1 in 5 thoracic donor organs transplanted in the U.S. were preserved and transported using a Paragonix device. The Paragonix SherpaPak® System is the most commonly utilized FDA-cleared and CE-marked medical device for U.S. heart preservation and transport. According to 2022 transplant data, 19 out of the 30 largest U.S. heart transplant programs, as well as over 80 global transplant programs, rely on Paragonix devices to safely preserve, track, and transport critical donor organs to their intended recipients.

Gunderson Dettmer acted as legal counsel for Paragonix Technologies. Sheppard, Mullin, Richter & Hampton LLP and Knobbe Martens acted as legal counsel for Signet Healthcare Partners. Terms of the transaction were not disclosed.

About Paragonix Technologies

Paragonix Technologies (“Paragonix”) is a leading provider of Advanced Organ Preservation (“AOP”) devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ in transit. Every Paragonix AOP device natively integrates with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonixtechnologies.com

About Signet Healthcare Partners

Signet Healthcare Partners ("Signet") is a leading provider of growth capital to innovative healthcare companies, specializing in pharmaceutical and medical device sectors. The firm maintains a disciplined, yet flexible investment approach and collaborates closely with its portfolio companies to enhance value. With a proven track record of successful investments over its 25-year history, Signet has raised cumulative capital commitments exceeding $500 million and invested in over 55 companies. For more information, visit www.signethealthcarepartners.com

Goodwin Biotechnology, Inc. Is Now GBI!

PLANTATION, FL-- Goodwin Biotechnology is becoming GBI and expanding to launch a brand-new, larger-capacity cGMP biologics facility.

Though the name may change, GBI’s mission remains the same: from clinical to commercial products, providing high-quality, cost-effective, flexible, and timely cGMP-compliant manufacturing solutions to eliminate the manufacturing risk for companies developing complex biotherapeutics.

GBI says it is as committed as ever to bringing its decades of experience to new and existing partnerships with those seeking a reliable CDMO that can nimbly face the various challenges that arise throughout every stage of the development and manufacturing cycle.

What Does GBI Do?

“Since we started more than 30 years ago,” says CSO Muctarr Sesay, Ph.D., “We’ve completed over 500 projects for more than 150 clients. We continue focusing on monoclonal antibodies (mAbs) because GBI has so much experience and depth with them. Still, we also have experience with modified and more complex antibody-based molecules, such as fragments, bi- and tri-specifics, other recombinant proteins, as well as the very specialized area of bioconjugation (antibody–drug conjugates (ADCs) and bioconjugates).

“Our two greatest strengths are our process and technology development and our cGMP manufacturing capabilities for biologics — including both drug substance (DS) and drug product (DP). We have clients who are doing first-in-human and early-stage clinical trials, as well as products that are in late-stage trials; thus, our integrated IND- and BLA-enabling experience and robust platform-based approach is critical for them.”

“GBI has handled many different projects in both late and early stages,” says VP of Business Kenneth Meek, “which has enabled us to develop what we call a Single Source Solution for our clients. This includes GMP cell banking, analytical methods development, antibody characterization services, clinical cGMP manufacturing, upstream cell culture production, downstream purification, bioconjugation, stability testing, and aseptic fill and finish. We even offer connections to our strategic partner networks for cell line development and other services. Our capabilities over such a large breadth of specialized services means we provide our clients with the solutions and support their project needs when they need it."

GBI’s CEO Darrin Schellin says, “We’re an end-to-end CDMO, simplifying the process and speed to and through the clinic while maintaining comprehensive communication and transparency, flexibility, and agility that our clients need. We have deep experience with complex biologics, having successfully produced various classes of DS and DP, not only antibodies but also ADCs and many other bioconjugates (including theranostics, radioimmune conjugates, photoimmune conjugates, antibody–peptide conjugates, vaccine conjugates, and others), bispecifics, Fc fusion proteins, recombinant proteins, cytokines, enzymes, growth factors, extracellular vesicles, exosomes, biosimilars, and biobetters, all from our facility in Florida, USA.”

What Sets GBI Apart?

“At the end of the day,” says CEO Schellin, “in this age of high innovation, complex, high-tech products, stretched supply chains, and geopolitical risks, GBI is built to help its clients simplify their product supply chains by providing technology, analytics, GMP drug substance and GMP drug product manufacturing, all within one over-arching relationship and from the same site in Florida. And while we’ve worked with large companies, we do this particularly well for those smaller, nimble, highly innovative companies who need a partner that intrinsically understands them. That is our sweet spot, what is unique and truly sets us apart.”

Schellin adds, “The next several years are going to mark a significant period of growth for us. GBI is launching a brand-new, fully integrated cGMP biologics facility that will expand our capabilities, with multiple bioreactor manufacturing trains ranging from 200 L to 2000 L, and make it easier and faster than ever to work with GBI, no matter the scale or stage of your project.

“We thank our clients for their continued and unwavering support. Our committed team is on a journey to commercialize our clients’ products as we move GBI into a late-stage clinical and commercial manufacturing focus. We have a cultural commitment to meeting the market’s expectations, and our very experienced scientists and engineers are dedicated to solving our client’s problems every day by shepherding their products toward the success they and their patients are waiting for.”

LAXAI Receives Investment from SIGNET Healthcare Partners

Integrated provider of drug discovery, development, and manufacturing services to leverage SIGNET’s pharma services expertise for business growth

NEW YORK--(BUSINESS WIRE)--LAXAI Inc. (“LAXAI”) announced today that it has received a growth capital investment from SIGNET Healthcare Partners (“SIGNET”), a New York-based healthcare private equity firm. This significant equity investment from SIGNET aims to provide LAXAI with a long-term, well-capitalized financial partner that will support LAXAI’s growth strategy.

LAXAI, including its subsidiaries, is an Integrated Contract Research, Development, and Manufacturing Organization (“CRDMO”) that delivers solutions in drug discovery, chemical process R&D, and GMP manufacturing for innovator pharmaceutical, biotech, and specialty chemicals companies globally. LAXAI operates a drug substance manufacturing facility (accredited by several regulators including the U.S. FDA and EU) and a state-of-the-art Innovation Centre in Hyderabad (India). A substantial portion of SIGNET’s investment will be utilized to enhance LAXAI’s capabilities and establish technical operations in the U.S.

LAXAI’s Chairman and Managing Director Vamsi Maddipatla said “LAXAI has been a trusted partner in the pharmaceutical and specialty chemical space providing client focused contract research and development services.” SIGNET’s investment will enhance LAXAI’s infrastructure and further augment operations to help our customers and partners maximize innovation and productivity. "We are very pleased to welcome SIGNET as a partner to help accelerate growth and achieve our ambitious long-term objectives. We look forward to leveraging SIGNET’s knowledge and network as we continue to expand and enhance operations.”

SIGNET Managing Director Nikhil Puri said "Pharmaceutical outsourcing has become mission-critical within drug development. Our investment in LAXAI is an attractive opportunity for SIGNET to partner with another CRO/CDMO business that was seeking an experienced partner to help execute its next phase of growth. We were attracted to LAXAI due to its vertically integrated offering, strong scientific capabilities, customer-centric approach, cost competitiveness, and management team strength. We see a strong opportunity for SIGNET to leverage its network and prior CRO/CDMO investment experience to accelerate growth.”

Tempus Law Associates and Richards, Layton & Finger served as legal advisors to LAXAI. JSA Advocates & Solicitors and Sheppard, Mullin, Richter & Hampton LLP served as legal advisors to SIGNET. Terms of the transaction were not disclosed.

About LAXAI Inc.

LAXAI offers contract research, development, and manufacturing solutions to pharmaceutical and specialty chemical companies globally. For more than a decade, LAXAI has collaborated with pharmaceutical companies across the value chain and partnered on multiple medicinal chemistry, integrated drug discovery, CMC Programs, and scale-up of custom-made specialty fine chemicals. For more information, visit www.laxai.com.

About SIGNET Healthcare Partners

Headquartered in New York, NY, SIGNET is an established provider of growth capital to innovative healthcare companies. SIGNET invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm invests primarily in pharmaceutical and medical device companies. As an active investor, SIGNET partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 24-year history, the firm has developed a strong reputation and track record of successful healthcare investments. Signet has raised funds with total capital commitments of over $500 million and has invested in more than 55 companies. For more information, visit www.signethealthcarepartners.com.

Contacts

Akash Baheti
LAXAI Inc
akash@laxai.com

Emad Piracha
SIGNET Healthcare Partners
emad.piracha@signethp.com