Massachusetts is the cornerstone for academic and research institutions and life sciences companies involved in medical device, pharmaceuticals, biotechnology, and more. But one sector, manufacturing, has reemerged and was critical to combatting the pandemic this past year. In Massachusetts, biomanufacturing development and facilities have grown exponentially over the past five years with over $1.9 billion* invested in developing new or expanding existing biomanufacturing facilities.
During the 2021 BIO Digital conference in June, Massachusetts touted two companies, Lykan Bioscience and Resilience, for cutting through the noise and forging the future of biomanufacturing. Lykan Bioscience is based in Hopkinton and is a contract development and manufacturing services organization focused on cell-based therapies. With decades of biopharmaceutical industry experience, Lykan offers a full range of development and manufacturing services. Their state-of-the-art, purpose-built, clinical and commercial manufacturing facility offers eight independent manufacturing suites and is uniquely designed to fully integrate cGMP principles and advanced software solutions to enable real-time testing and release of life-saving treatments to patients on behalf of their partners.
Resilience is changing the way medicine is made. With their own network of high-tech, end-to-end manufacturing development solutions they are leveraging innovation to better serve scientific discovery, withstand disruptive events, and reach those in need faster. Their manufacturing facility, located in Boston, will serve as a hub for biopharma manufacturing.
In addition to industry manufacturing facilities, academic institutions in Massachusetts are instrumental in advancing the biomanufacturing space, including the Massachusetts Biomanufacturing Center at UMass Lowell and the Biomanufacturing Education and Training Center at Worcester Polytechnic Institute. This past fiscal year, the MLSC provided more than $850,000 to support projects from UMass Lowell and a collaboration between Northeastern University and MIT, which were funded through the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The NIIMBL grant program is a collaborative, precompetitive program designed in 2017 to support technology advancement in biomanufacturing as well as the development of training programs that will advance biopharmaceutical manufacturing in the United States.
There is no question that biomanufacturing is essential to the life sciences ecosystem. Between the current demand to distribute vaccines at a rapid rate to the advancement of novel modalities, biomanufacturing is and will be a critical component to the ecosystems supply chain and overall job growth for Massachusetts.
*All charts and data points are from MassBio's 2021 Industry Snapshot
*MassBio State of Possible 2025 Report
CERES (Cell Engineering Research Equipment Suite) at Worcester Polytechnic Institute (WPI) is a fee-for-use core lab designed to provide WPI researchers and regional industry and academic partners access to state-of-the-art instruments for quantitative analysis of engineered cells. It is located within the WPI Biomanufacturing Education and Training Center, Suite 2400, 50 Prescott Street. CERES was made possible by a MLSC capital award ($877,314) in 2020.
MLSC funds supported the purchase of key equipment to create a modular core facility focused on high throughput cell analytics, providing startups access to resources needed to bring cell-based products to market. This facility is of broad interest to researchers and companies developing cell and gene therapies, engineering cells to manufacture commercially valuable products, defining critical quality attributes (CQAs) for cell, gene therapy, and biomolecule analysis and characterization, among many other applications. In addition, the facility will accelerate research probing fundamental mechanisms of cell and tissue biology with applications in cancer, immunology, cardiovascular disease, infectious disease, synthetic biology, tissue engineering and regenerative medicine.
A major indicator of success for CERES will be the growth and maturation of the biotech discovery ecosystem in central Massachusetts, especially in the number of startup companies supported by CERES. That is why it is so essential the equipment capabilities were designed through partnership between WPI and Massachusetts Biomedical Initiatives (MBI). MBI is the longest-running life sciences incubator in the Commonwealth, currently home to more 50 companies and has graduated almost 100 companies, which employ over 800 in the local life sciences cluster.
In August 2020, the ribbon was cut on MBI’s new StartUp & ScaleUp Centers. The expansion of MBI, which redeveloped space at 17 Briden Street in Worcester provides private, secured laboratories for early-stage companies ranging from 100 – 3,000 square feet. The project was a partnership with the Commonwealth of Massachusetts and funded with a $4 million MLSC capital grant. The facility soft-opened in June 2020 and is already at nearly 100 percent capacity with the MBI team still fielding strong demand from companies interested in locating to MBI/Worcester.
In April 2021, the MLSC announced a $750,000 investment supporting three Lowell-based companies. Decoy Therapeutics, EnVision Endoscopy, and Haystack Diagnostics will receive a $250,000 investment in the form of a convertible note. All three companies are locating to the Massachusetts Medical Device Development Center (M2D2) located at the UMass Lowell campus.
The MLSC awarded the three convertible note investments through its Seed Fund, in which companies received up to $250,000 to support novel innovations in all life sciences sectors, including Diagnostics, Digital Health/Bioinformatics, Medical Devices, MedTech, and Therapeutics.
EnVision Endoscopy, Decoy Therapeutics, and Haystack Diagnostics are three of the latest arrivals to M2D2, a joint venture of UMass Lowell and UMass Medical School in Worcester, which assists entrepreneurs with all aspects of moving new products and technologies from concept to commercialization.
Also in April, M2D2 once again hosted its annual pitch contest, the M2D2 $200k Challenge, showcasing the inventions of early-stage medical device, diagnostic and biotech companies that are poised to revolutionize health care. This year’s grand prizewinner was AcousticaBio, a Cambridge-based company that has developed a means to reformulate intravenous medications so they can be administered via an injection under the skin. The startup will receive $50,000 in seed funding to advance the invention from the MLSC, the event’s top sponsor and founding sponsor of M2D2, along with $27,000 of in-kind services from M2D2 and Amgen, another event sponsor.
A preclinical stage biotech company building a pandemic preparedness drug development platform using AI design of peptide ‘decoys’ that directly interfere with viral replication machinery. Decoy’s lead product, SARS-Guard™, is a nasal spray being developed for SARS-Cov-2 prevention and early treatment as a complement to vaccines. SARS-Guard™ is expected to be equally effective against all SARS-CoV-2 variants. Published preclinical data demonstrate that peptide decoys are effective against a broad spectrum of coronaviruses and enveloped viruses.
The company is developing novel devices for gastrointestinal endoscopic surgery for use in procedures that have traditionally required intensive care, long and costly hospital stays, and high rates of morbidity and mortality. The therapeutic site, accessed with flexible endoscopes through natural body orifices without incisions, can result in faster patient recovery, reduced number of days at the hospital, and an overall reduced cost of care.
Haystack has developed a complete solution to address the clinical unmet need to improve the diagnostic procedure for neuromuscular disorders (NMDs), improve patient care, and delivering a technology at an affordable cost. The company invented a patent-pending needle impedance electromyography (iEMG) enhanced technology to improve the diagnosis and means for monitoring the therapeutic treatment of those patients suffering from NMDs.
The Institute for Applied Life Sciences (IALS) located at UMass Amherst aims to translate fundamental research into innovative product candidates, technologies, and services that deliver benefits to human health and well-being. To achieve this vision, IALS combines deep and interdisciplinary expertise of more than 200 faculty led research groups from 29 departments on the UMass Amherst campus, with the diverse capabilities from industry and government partners.
IALS is the MLSC’s largest capital project, a $95 million investment. In 2020, the MLSC awarded additional funding totaling $2 million in capital grants to support four of UMass Amherst campus’ Core Facilities managed by IALS. More than 30 Core Facilities, managed by IALS, have been launched to support a wide range of projects from device prototyping, precision manufacturing and roll-to-roll fabrication, to human motion and gait studies, calorimetry, magnetic resonance imaging and spectroscopy, as well as, EEG and sleep studies. These facilities are equally accessible to academic, government, and industry collaborators.
Additionally, thanks to the MLSC’s investments, IALS has been able to establish internship opportunities within its core facilities to give students and research groups hands-on, experiential training that they take with them into small business, industry and post-graduation-giving back to the economy.
IALS also works with industry partners to combine the best in academic innovation with an industry-like focus on delivering commercially significant products, services, and technologies over a defined timeline. Hence, by design, IALS is product-focused, interdisciplinary, collaborative, outward-looking, and entrepreneurial. To date, IALS has engaged approximately 300 industry partners.
