Welcome! The Bloomington Life Sciences Partnership is a collaborative effort dedicated to continued life sciences business growth in greater Bloomington, Indiana - a nationally recognized leading metro area in medical devices, contract pharma, biotechnology, basic research and life sciences workforce development.

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The Mill’s 2nd Annual INX Pitch Event Sends Five Qualifiers to Indy for INX

Posted August 8, 2018

August 6, 2018 FOR IMMEDIATE RELEASE For more information, please contact: Pat East pat.east@cofoundventures.com 317.965.2155 Bloomington, Ind – Dimension Mill’s 2nd Annual INX Pre-Qualification Pitch Event was held on Wednesday, July 25th, 2018. Twelve pitches were presented at the event. Five were chosen to qualify for a trip to Indianapolis. Participants were given seven minutes to pitch their business, and seven minutes for a brief question and answer session led by the judges. The judges for this event were Mark Gramelspacher, EIR at Elevate Ventures;, the state’s venture capital fund Oscar Morales, Founder & Managing Director at VisionTech, the state’s largest angel group; and Teri Willey, Executive Director & Fund Manager at the IU Philanthropic Venture Fund, their new $15mm startup fund. The judges, prominent and respected investors in Indiana’s startup community, were impressed by the wide array of innovative companies that participated, and chose five winners from the twelve participants at the event. The five winners of the event, held at the Hoosier Energy complex in Bloomington, are a diverse set of companies that showcase the immense creativity of the startup community that The Mill plans to grow with its 19,000 square-foot facility, which seeks to be a hub of startup innovation and investment for Bloomington. The winners of the pre-qualification event were diverse in their solutions and showcased the immense amount of talent and innovation that exists within the Bloomington and area communities: Underdog Apparel, a company looking to create unique high-quality apparel for underserved collegiate markets; ShipperTech, which provides a secure solution to buyers and sellers in online marketplaces like Craigslist; The Bee Corp, which provides a unique data-driven solution for growers and beekeepers; Wave Therapeutics, which provides a solution to reduce and eliminate bedsores and discomfort for patients in nursing homes and other medical facilities; and Heliponix, which has developed the GrowPodTM , a device that can grow fresh, organic produce in the convenience of the customer’s home. “This year’s event could not have gone better! Good attendance, 12 solid pitches, smooth logistics, 5 winners instead of 2 last year, the Hoosier Energy venue was world-class and impressive, and the judges were professional investors and their questions, critiques, and coaching were exactly what our startups needed,” said Pat East, Executive Director of The Mill. The Mill is a 19,000 square-foot coworking, community collaboration, and high-potential startup business incubation space scheduled for completion on October 31st, 2018.   Please follow and like...

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BioCrossroads accepting entries for 2018 new venture competition

Posted July 2, 2018

Since 2012, BioCrossroads’ New Venture Competition has uncovered a steady stream of the most promising life sciences startups by offering awards, recognition and venture capital. To date, the competition has awarded more than $350,000 to 23 startup companies, which have successfully gone on to secure an additional $35 million in follow-on funding. “Through the competition, we have identified the next generation of life sciences start-ups – both from research done in academic settings as well as from entrepreneurs working independently and from all corners of Indiana.” said David Johnson, president and CEO, BioCrossroads. “It’s been gratifying to see some of our winners from a few years ago make progress.  SpeechVive and Diagnotes have products in the market; 2013 winner Spensa Technologies was acquired; and Scioto BioSciences, who won in 2016, just raised nearly $ 2 million in venture capital from investors including BioCrossroads.” In addition to a cash prize of $25,000 and exposure to hundreds of influencers at the Summit, the winners of the New Venture Competition will have access to the Indiana Seed Fund (ISF) staff and the fund’s network of resources to provide business planning and early-stage strategic support. They will also have the opportunity to make a presentation to the ISF investment committee for added exposure. Second and third place companies will be awarded cash prizes of $15,000 and $10,000 respectively. The Competition is open to life sciences (biotechnology, pharmaceutical, medical device, diagnostic, ag-biotech) and health information technology companies holding a substantial nexus to Indiana. Startups will enter a highly competitive process with first round applications due Aug. 13, 2018. Five finalists will compete for cash prizes Oct. 9 during the 2018 Indiana Life Sciences Summit and be announced at the reception that evening at the Marriott Downtown Indianapolis. Taft Stettinius & Hollister LLP is the presenting sponsor. VisionTech Partners, Metazoa Brewing Company, Halo Capital Group and 16 Tech are also supporting the Competition through judging and sponsorships. For additional information and to apply, please visit www.biocrossroads.com/newventure About BioCrossroads BioCrossroads (www.biocrossroads.com) is Indiana’s initiative to grow the life sciences, a public-private collaboration that supports the region’s research and corporate strengths while encouraging new business development.   BioCrossroads provides money and support to life sciences businesses, launches new life sciences enterprises, expands collaboration and partnerships among Indiana’s life science institutions, expands science education and markets Indiana’s life sciences industry.  The initiative has formed several new nonprofit organizations, including Indiana Health Information Exchange, BioCrossroadsLINX, OrthoWorx, Datalys Center and the Indiana Biosciences Research Institute. Please follow and like...

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Cook Group announcement expands life sciences industry in Bloomington

Posted September 19, 2017

Cook Group announcement expands life sciences industry in Bloomington

Bloomington, Ind. – Today, two Cook Group announcements mark significant, positive changes for the future of Bloomington. First, Cook Group and Catalent, Inc. announced a purchase agreement for Catalent (NYSE: CTLT) to purchase Cook Pharmica. In addition, Cook Group, through its subsidiary Cook Properties, has signed an agreement to purchase the former GE site near Cook’s world headquarters on Bloomington’s west side. “Both of these decisions will have a positive impact on our employees, our business and also on the local economy and workforce – creating new jobs, expanding the local life sciences industry, and attracting new talent to our region,” said Pete Yonkman, president of Cook Group and Cook Medical. “Today, more than ever, we are committed to Bloomington. It’s our home.” Cook Group and Catalent enter into purchase agreement for Cook Pharmica Catalent is a leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. Cook Pharmica expands Catalent’s capabilities by adding more drug substance and drug product expertise and capacity to serve patients world wide. Upon completion of the sale, Cook Pharmica and Catalent will create a new leader in the rapidly growing biologics development, analytical, manufacturing and finished product supply industry. “We only consider opportunities like this when it clearly benefits the patients we serve, our employees, the community, and both companies,” said Yonkman. “In this case, we feel confident that this is a good decision for all involved, including the more than 750 Cook Pharmica employees whose jobs are all secure. All of those employees will become part of Catalent’s growing biologics business and remain under the leadership of Cook Pharmica’s president, Tedd Green.” With Cook Pharmica’s available space and expertise, Catalent will create a biologics development and manufacturing center of excellence. The purchase allows Cook Pharmica to deepen relationships with customers and grow their already successful business. “This purchase is a recognition of the hard work, dedication, and community spirit of the men and women who have helped Cook Pharmica to grow. The Bloomington area has been a terrific home for this fast-growing business, and we look forward to further strengthening Cook Pharmica’s partnership with the community in the years to come,” said John Chiminski, president and CEO of Catalent. Catalent plans to invest aggressively in Cook Pharmica, and in the rest of the Catalent Biologics network to build a true global leader in the biologics market, which will help Catalent to improve the lives of patients around the world. The completion of the $950 million transaction is subject to customary closing conditions, including approval from regulatory authorities, and is expected to occur in the fourth quarter of this calendar year. Cook Group purchase of former GE site Cook Group is expanding its medical device business and reaffirming its commitment to Bloomington by signing a purchase agreement for the vacant GE property on Curry Pike. This purchase allows Cook the flexibility to address some immediate space needs at Cook Medical’s global headquarters and to more quickly address future goals to modernize its manufacturing process for increased efficiency. Over the next 10 years, if market growth continues as planned, Cook Group expects to add 500 jobs in Bloomington at this new facility and its Daniels Way location. “We need more space to accommodate our growth and to...

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AB BioTechnologies Breaks Ground on $10.5M Project

Posted June 1, 2017

FOR IMMEDIATE RELEASE BLOOMINGTON, Ind. (May 31, 2017) – Construction has begun on a new 23,000-square foot pharmaceutical manufacturing facility for AB BioTechnologies in Monroe County. The company is a contract development and manufacturing organization (CDMO), and plans to add clinical and small-scale commercial manufacturing for injectable drugs later this year. AB BioTechnologies announced it was expanding in January and planning to hire over 30 positions over the next five years. The company was founded in 2008 by J. Jeff Schwegman, Ph.D. “Entrepreneurs and small businesses like AB BioTechnologies are driving economic growth and innovation in Indiana,” said Indiana Economic Development President Elaine Bedel. “Small businesses employ more than 1.2 million Hoosiers across the state, providing quality, good-paying jobs. As one of the Indiana companies recognized for its growth during Small Business Week in May, we look forward to watching AB BioTechnologies continue to expand and create new opportunities for Hoosiers.” “We are very grateful that AB Bio Technologies has chosen our community as the site for its innovation,” said Lynn Coyne, President of the Bloomington Economic Development Corporation. “We are proud to support their growth and bright future with the many resources in our area.” AB Biotechnologies received the Indiana Small Business Development Center 2017 Economic Development and Growth Through Entrepreneurship (EDGE) Award in small business earlier this month. About AB BioTechnologies Jeff Schwegman, Ph.D. founded AB BioTechnologies in February of 2008. Dr. Schwegman had more than 16 years of experience working in the contract development/manufacturing pharmaceutical industry before launching AB BioTechnologies, initially a teaching and consulting firm. AB BioTechnologies started small and budget efficient in the back bedroom of Dr. Schwegman’s home. In early 2010 the first small laboratory was opened, and the company quickly grew over the next few years tripling profits each year, adding new lab equipment, and going through two lab expansions to keep up with the demand for their services. For more information about AB BioTechnologies Inc., please visit www.ab-biotech.com. Please follow and like...

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Sintact Medical Systems Receives National Science Foundation Small Business Innovation Research Grant

Posted May 11, 2017

Sintact Medical Systems Receives National Science Foundation Small Business Innovation Research Grant

Phase 2 grant will advance development of Sintact’s surgical film, to include seeking regulatory approval.   [Bloomington] – May 10, 2017 – Sintact Medical Systems, a startup developing an implantable film that prevents internal scar formation following cardiothoracic and neurological surgery, announced today it was awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase 2 grant worth approximately $750,000. Previously, Sintact Medical was awarded SBIR Phase 1 and 1B grants in July and December 2015. The collective funds will significantly advance testing and development of the non-resorbable film, culminating in a 510(k) regulatory submission.   “With the Phase 1/1B grant, we were able to conduct animal studies and prove the concept of our product,” said Sintact Medical CEO Erik Robinson. “We saw tremendous success with the first studies and are eager to continue developing and fine-tuning the film for commercialization. We appreciate the support from the National Science Foundation with this second grant and without them we would not be able to bringing our technology to market so quickly and ultimately improve patients’ lives.”   Phase 2 of the NSF SBIR grant program is designed as a “commercialization acceleration” grant, which can be matched by outside investment through the Phase 2B program. Sintact Medical will conduct pre-clinical testing and development, which align with feedback obtained through a Pre-Submission interaction from the FDA.   Sintact Medical’s technology was developed through Robinson’s doctoral work at Northwestern University in collaboration with Ann & Robert H. Lurie Children’s Hospital of Chicago, which demonstrated a reduction in scar formation in a pilot cardiothoracic animal study. Follow-on studies completed during Phase 1/1B validated the technology through expanded studies.   Phase 2 of the NSF SBIR grant ends March 31, 2019. Upon completion of Phase 2, Sintact Medical will report results to the agency and will rely on external private investment to continue commercialization efforts.   Sintact Medical has received support from organizations such as Health Wildcatters, VentureWell and iBIO Institute’s PROPEL Center, all of which have assisted and invested in the company’s success. For more information on Sintact Medical and its surgical film technology, visit sintactmed.com.   About Sintact Medical Systems Sintact Medical Systems, Inc. develops non-resorbable films that separate adjacent organs from adhering to each other after surgery. The Sintact Film™ acts as a scar preventative barrier separating organ and tissue surfaces to significantly reduce the likelihood of scar formation and the associated post-operative complications. Sintact Medical was founded by Erik Robinson, PhD and Gali Baler, PhD in 2013 as a result of the founders’ doctoral research at Northwestern University. For more information visit sintactmed.com. Please follow and like...

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Indiana Ranked First in the Midwest for Business Second Year in a Row

Posted May 9, 2017

Indiana Ranked First in the Midwest for Business Second Year in a Row

INDIANAPOLIS (May 9, 2017) – Indiana ranked first in the Midwest and fifth in the nation for doing business by Chief Executive magazine, maintaining its position as a top state for business. The magazine’s “Best & Worst States For Business” ranking is based on surveys of more than 500 CEOs. According to Chief Executive, the results of the 13th annual survey show that CEOs favor states with friendly tax and regulatory climates, quality workforces and strong living environments, which includes cost of living, education and state and local attitudes toward business.  “Over the last 12 years, Indiana has worked to create a world-class economy by passing balanced state budgets, reducing regulatory burdens and investing in the future,” Governor Eric J. Holcomb said. “Today’s ranking reaffirms the benefits of our pro-business climate as we work to take Indiana to the next level.” As highlighted by Chief Executive, Indiana’s tax and regulatory policy ranks in the top 15 in the nation while the state’s workforce quality ranks in the top 10. The magazine highlighted Indiana’s focus on preserving and enhancing roads and bridges through Major Moves 2020 and recent legislation that will provide $1.2 billion in new annual funding by 2024 to support state and local infrastructure. As the Crossroads of America, this dedication to infrastructure will continue to strengthen Indiana’s competitiveness and quality of life by improving travel times for businesses, commuters and tourists.   Indiana’s ranking makes it the only Midwestern state in the publication’s top five. Among neighboring states, Ohio ranked No. 11, Kentucky ranked No. 22, Michigan ranked No. 36 and Illinois ranked No. 48.  The Chief Executive ranking comes on the heels of recent economic success stories in Indiana. Just last week, Infosys, a global technology firm, announced plans to establish a tech and innovation hub in central Indiana, investing $8.7 million and creating 2,000 high-skilled jobs over the next five years. Chief Executive magazine is a bi-monthly publication for top management executives published by the Chief Executive Group LLC. Founded in 1977, the Chief Executive Group LLC is headquartered in Greenwich, Connecticut. The full survey results are available online.  About IEDC The Indiana Economic Development Corporation (IEDC) leads the state of Indiana’s economic development efforts, helping businesses launch, grow and locate in the state. Governed by a 15-member board chaired by Governor Eric J. Holcomb, the IEDC manages many initiatives, including performance-based tax credits, workforce training grants, innovation and entrepreneurship resources, public infrastructure assistance, and talent attraction and retention efforts. For more information about the IEDC, visit www.iedc.in.gov.  – 30 – Media Contacts:  Abby Gras (IEDC) – 317.232.8845 or agras@iedc.in.gov Please follow and like...

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Singota™ Solutions Expands in Bloomington, Adding World Class Sterile Filling Technology

Posted March 1, 2017

Singota™ Solutions Expands in Bloomington, Adding World Class Sterile Filling Technology

Singota Solutions, a life sciences contract service provider, brings new technology to the US with its sterile filling expansion. Bloomington, IN (February 28, 2017)- Singota Solutions announced it has completed installation of the pharmaceutical industry’s most advanced manufacturing technology for use in filling injectable drug products into vials, syringes, and cartridges. The centerpiece of the technology addition is the Vanrx Pharmasystems SA25 robotic work-cell. CEO of Singota Solutions, Alisa Wright, expressed the importance of this development: “Singota is the first company in the US and North America to have this world class equipment. Being an early adopter of this new technology is not just exciting, but is an essential part of the company’s future growth and our ability to help our clients bring new drug products to market faster.” Chris Procyshyn, CEO of Vanrx Pharmasystems LLC commented, “The Vanrx system was created to manufacture the next generation of innovative therapeutics. Our equipment utilizes the latest advancements in robotics, gloveless isolator and machine vision technologies to automate the filling of injectable drugs into nested vials, syringes, and cartridges. We have been extremely pleased to work with Singota in this endeavor.” Coupled with the installation of the SA25 unit, Singota has completed construction of several thousand square feet of clean rooms and supporting infrastructure. Singota’s Brent Lieffers, Senior Director of Operations said, “We have reached the end of the construction and equipment installation phase of our expansion program and are now beginning validation activities. We expect to attain operational status in the 2nd quarter of this year.” To support the expansion, the company has already added several new job positions with more growth opportunities expected in the near future. Wright added, “We’d like to thank all of our friends, employees, suppliers and contractors for their support. A special thanks goes to Strauser Construction Company of Bloomington, Indiana for a tremendous job on our facility construction, meeting our project needs and an aggressive timetable.” About Singota Solutions Singota Solutions is a service provider to the pharmaceutical, animal health, and medical device industries. Founded in 2006 as BioConvergence, the company is a woman-owned business operating in a 72,000 square foot facility in Bloomington, Indiana. The company’s service lines include supply chain operations, drug formulation development, analytical methods development & testing activities, labeling & kitting operations, and aseptic manufacturing services later in 2017. For more information, visit www.singota.com Please follow and like...

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AB BioTechnologies Expanding in Monroe County

Posted January 11, 2017

AB BioTechnologies Expanding in Monroe County

BLOOMINGTON, Ind. (Jan. 11, 2017) – AB BioTechnologies, a pharmaceutical development company located in Monroe County, will invest $10.5 million to construct and equip a new 23,000 square foot manufacturing facility in Monroe County, and create up to 33 new high-wage jobs by 2020. The company will add manufacturing services for formulating, filling, freeze-drying, and packaging injectable drugs for Clinical Trial studies.   “This is a fantastic opportunity for AB BioTechnologies, Bloomington, Monroe County, and the state of Indiana,” said J. Jeff Schwegman, Ph.D., founder and chief executive officer of AB BioTechnologies. “We are one of only a handful of companies in the world that will offer all of these services in a small, nimble company format, and Monroe County is the perfect place for us to expand. The presence of a locally skilled workforce and access to graduates from Indiana University and Ivy Tech will assist us in hiring a competent workforce.”   AB BioTechnologies was founded in 2008 and has expanded into an internationally-recognized drug development company in the pharmaceutical industry. With the addition of its contract manufacturing services, the company will be able to shorten the time it takes to transfer a drug from concept to the clinic.   “AB BioTechnologies is an example of the future of Monroe County’s economic potential,” said Lynn Coyne, President of the Bloomington Economic Development Corporation. “It began as an entrepreneurial effort and through talent and commitment is becoming an important participant in the global economy, providing quality employment opportunities in our community.”   The Indiana Economic Development Corporation offered AB BioTechnologies, Inc. up to $290,000 in conditional tax credits and up to $30,000 in training grants based on the company’s job creation plans. Monroe County offered a tax abatement over a ten-year period.   “We are excited to have AB BioTechnologies choose to invest in the county’s westside economic development area,” Monroe County Councilmember Geoff McKim said. “AB BioTechnologies will contribute to our vibrant local economy, and bring new high-wage jobs to Monroe County residents. We are pleased that the company recognizes our community’s skilled workforce, and we welcome their expansion with open arms.”   The company plans to begin hiring early this year for technical and support positions. Interested applicants may apply by submitting a resume to info@ab-biotech.com.   About AB BioTechnologies Jeff Schwegman, Ph.D. founded AB BioTechnologies in February of 2008. Dr. Schwegman had more than 16 years of experience working in the contract development/manufacturing pharmaceutical industry before launching AB BioTechnologies, initially a teaching and consulting firm. AB BioTechnologies started small and budget efficient in the back bedroom of Dr. Schwegman’s home. In early 2010 the first small laboratory was opened, and the company quickly grew over the next few years tripling profits each year, adding new lab equipment, and going through two lab expansions to keep up with the demand for their services. For more information about AB BioTechnologies Inc., please visit www.ab-biotech.com.   About BEDC The BEDC is a not-for-profit organization dedicated to the retention, development and attraction of quality jobs in Monroe County. The BEDC is led by a partnership of private industry leaders, the City of Bloomington, Monroe County, Indiana University and Ivy Tech Community College–Bloomington. For more information, visit www.bloomingtonedc.com. ###   Media Contacts: April Ladd (AB BioTechnologies) – 812.287.8493 ext. 104...

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Ivy Tech Bloomington awarded $85,000 federal grant for biotechnology career training in rural high schools

Posted August 31, 2016

Ivy Tech Bloomington awarded $85,000 federal grant for biotechnology career training in rural high schools

BLOOMINGTON – Ivy Tech Community College’s Bloomington campus was awarded a grant of $85,000 through the Indiana Department of Education’s Carl D. Perkins Title IV federal grant program. Ivy Tech Community College statewide received four grant awards total, in the following regions: Bloomington, Northeast, Southeast and Columbus, with a total combined value of nearly $302,000. Bloomington campus funds will be used to develop life science industry career and technical education pathways for rural Indiana high schools. The project will enable high school students to complete six college credits that count toward two Ivy Tech certificates: Biopharmaceutical Manufacturing and Medical Device Quality. The credits also count toward an Associate of Applied Science degree in Biotechnology. Additionally, the grant will fund professional development for high school teachers, awarding certification renewal credits upon training completion. Training will enable instructors to teach college-level biotechnology courses and will allow students to earn college credits, complete their education at Ivy Tech, and enter life science careers. Participating schools include Bloomfield High School, Brown County High School, Eastern Greene High School, and Owen Valley High School. Grant funds will cover stipends for 15 high school teachers to attend a two-week intensive summer workshop, stipends for 3 Ivy Tech instructors to develop the workshop, and supplies and equipment. Through Ivy Tech’s dual credit program, the grant will also cover the cost for high school students to earn college credits toward the Ivy Tech certificates. Ivy Tech’s certificates, Pharmaceutical Manufacturing and Medical Device Quality, require 18 credits each. High school students will earn six credits toward them, completing Survey of Biotechnology (BIOT 100) and Survey of Biotechnology Manufacturing (BIOT 102). Upon successful completion, students will be qualified for middle-skill level jobs in pharmaceutical manufacturing and medical device quality. Students can apply their certificates to earn the Associate of Applied Science in Biotechnology to qualify for higher-skill level jobs, including Laboratory Technician, Quality Control Technician, Research Associate, Quality Assurance Associate, Manufacturing Associate, Process Development Associate, Calibration Technician, Documentation Technician, Inspector, Production Technician, Regulatory Affairs Clerk, Regulatory Affairs Technician, or Quality Investigator. “Ivy Tech’s Biopharmaceutical Manufacturing and Medical Device Quality certificates were developed out of industry needs to build a pipeline of employees for middle-skill level technical jobs,” said Dr. Sengyong Lee, program chair of biotechnology at Ivy Tech Bloomington. “Our certificates and biotechnology degree are in demand by area employers, including Cook Medical, Cook Pharmica, Baxter BioPharma Solutions, Boston Scientific, Singota Biosolutions, AB Biotechnologies, and others. Although our biotechnology program has a 96% job placement rate, the growing number of jobs in the industry are outpacing the number of students in the workforce pipeline,” he added. The project will happen in several phases beginning in fall 2016, when high school instructors will begin to be identified for training. In summer 2017, 15 high school instructors will complete the two-week intensive summer workshop. By fall 2017, a total of 50 students will have completed a total of 300 college credits that will count toward the Biopharmaceutical Manufacturing and Medical Device Quality certificates. More information about Ivy Tech Community College Bloomington’s biotechnology program can be found online at www.ivytech.edu/biotechnology. Please follow and like...

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Reducing Variability in Small Batch Drug Kitting

Posted June 16, 2016

Reducing Variability in Small Batch Drug Kitting

What happens when a large pharmaceutical packaging company that usually prepares hundreds of thousands of doses of mature drug products for shipments to commercial distributors needs to prepare a small batch run of product – say, 500 or 1000 doses for a clinical trial? Do they simply borrow one of their high-speed lines for an hour or two? Probably not. There are major differences between the highly automated, high volume approaches versus those employed by short run, manually based operations. Preparation of the final, outgoing product consists of gathering and assembling several components for the kit for each dose, which is for the most part accomplished by hand. Whatever is in that kit is either what that patient is going to see, or what the clinician is going to have available to administer the product. How does one make sure that it is correct? In a manual operation at a short run facility, there is not a lot of automated quality assurance. However, the required outcome is no different than it would be for a big commercial batch. The issue then is: how does one achieve that same level of quality at the endpoint for a small batch drug kitting process without the automation used in the high volume lines? Why Kit Contents are so Important In addition to the drug product, a kit might include a diluent vial, or a buffer packet, or a syringe. It may also include a package insert – the printed material mandated by the FDA for commercial products – that provides relevant information for patients and physicians. The kitted product is the sum of all the parts – everything that is necessary to dose a patient. If there are two of some component of which there should only be one, or if something is missing, we’ve failed. Typically, the most expensive component in the kit is the active ingredient – the drug itself. But a failure represents more than just an expense. An incorrectly kitted product can have other significant and detrimental implications. It may mean the clinician cannot administer the product. A patient being treated for a serious disease, who may have traveled a long way to receive treatment, has to be sent home untreated. The clinical trial schedule can be thrown off. If there is a discrepancy with the labeling, such that there is concern over identity or potential mix-ups, the entire production batch is jeopardized. So the stakes are high, even for small runs. Many products shipped to a clinical trial site are to some extent kitted – packaged to meet the specific needs of a clinic running a specific trial of a known population size and dosage requirement. For example, if the clinic is going to treat eight patients, and each is going to be seen twice, that’s 16 kits. The clinician needs to pull the kit off the shelf and have everything there, ready to go, minimizing the chance the clinician can introduce their own variability that might skew the data. And the kit has to be designed to protect the components from being lost once the package is opened, without being cumbersome to open and use. Small-Volume QA On a high-speed production line, the various components of the kit can be added through some means of automation...

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