UPM Pharmaceuticals  

BRISTOL,  TN 
United States
http://WWW.UPM-INC.COM
  • Booth: 1519

UPM is a full service CDMO specializing in the development and manufacturing of solid oral and semi-solid dosage forms, offering our clients support and expertise from concept to commercialization.  We are US based, family owned and client focused with a management and project leadership team who has decades of pharma and contract drug development and manufacturing experience.  UPM offers low humidity suites, 4 Xcelodose for direct API in capsule, the ability to work with potent compounds and DEA- controlled drug substance capabilites from CII-CV. Our processes include dry blend, dry granulation, wet granulation and aqueous coating.


 Press Releases

  • Facilitating Implementation and Customer Service with Offline Serialization

    Author: Tyler Ewald, and Joey Quales, UPM

    Mar 12, 2018 10:33:00 AM   PAP-Q1-18-CL-005

    Originally published in Pharma’s Almanac Q1 2018. 

    Even though the FDA has extended the deadline for compliance with unit serialization requirements, UPM Pharmaceuticals serialized its first commercial product in May 2017, well ahead of time. The use of an offline serialization system facilitated implementation and provides numerous benefits to our company and our clients. 

    Rising Incidence of Fraudulent Medicines

    Drug counterfeiting is a global and growing problem. In 2010, the World Health Organization (WHO) estimated that the incidence of counterfeit drugs is less than 1% in developed countries and much higher in developing countries.1 As of November 2017, the WHO estimate that 1 in 10 medical products in low- and middle-income countries is substandard or falsified.2 Its Global Surveillance and Monitoring System, founded in 2013, had issued 20 global medical product alerts and numerous regional warnings and provided technical support in over 100 cases.

    In the US, between 2010 and May 2016, close to 1,400 adverse reactions related to counterfeit drugs were reported to FDA.3 This data does not include incidences of counterfeit or compromised medications that do not lead to any adverse reactions or have no effect. As a result, the true extent of the problem is unknown.

    Serialization Expected to Help

    Governments around the world have responded to the increasing presence of fake medicines in the drug supply chain by passing regulations requiring that pharmaceutical manufacturers implement systems that allow for the track-and-trace of drug products throughout the supply chain. Compliance is already required in some countries, while deadlines are fast approaching in others. The detailed expectations vary from country to country, and even over time within individual countries. They are also constantly evolving.

    In the US, serialization requirements were established in the Drug Quality and Security Act (DQSA), which became law in November 2013. The law applies to manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. Title II of the DQSA outlines the requirements for supply chain members with respect to the implementation of track-and-trace systems for prescription drugs in three phases over 10 years. The sharing of lot-level information was completed in 2015. The serialization of all product units and the sharing of this data were to be completed by November 2017; and the sharing of aggregate data linked to unit data to establish chain-of-ownership throughout the drug supply chain from the manufacturer to the patient was initially set for 2023.

    Track-and-Trace More Complex than Anticipated

    Most large pharmaceutical companies and a select few CDMOs have taken an aggressive approach to implementing comprehensive internal serialization solutions.4 Many companies, particularly smaller and medium-sized firms with limited resources, have adopted a “just-in-time” approach, implementing only those elements of the system needed to meet specific deadlines in different countries.5 There are still a large number of smaller companies that are just beginning to initiate internal track-and-trace programs. Others have elected to forego any internal efforts, preferring to rely on outsourcing partners. A few companies also remain that have not taken any action with regard to serialization.

    Implementing serialization solutions has, in fact, proven to be more complex and challenging than many pharmaceutical producers — both sponsor firms and contract development and manufacturing organizations (CDMOs) — expected. Companies must establish bi-directional data exchange connections with a wide range of suppliers and other partners (including clients and distributors for CDMOs), grapple with a dramatic increase in the quantity of data that must be generated and managed, stay up-to-date with evolving regulations in numerous countries, and implement their solutions without any disruption in the supply of their drug products.5 The FDA responded by extending the deadline for compliance with the establishment of unit serialization by one full year, to November 2018.

    Additional Considerations for Contract Manufacturers

    For any serialization system, definitions and formats for serial numbers must be determined. Sufficient space must be available on the product packaging to apply the serial number and other relevant data. A management system must be in place to allocate the serial numbers and link them to larger groups of unit packages, such as boxes and pallets (parent/child relationships) and to orders, shipments, etc. A system for handling other issues —­ repackaging, rework, returns, etc. — is also necessary.

    Implementing an effective serialization solution is, therefore, challenging for any type of drug manufacturer. In addition to being quite costly, serialization impacts many different company operations and thus requires input from representatives of many different groups. Labels must be redesigned, and large quantities of new data must be properly managed and shared with appropriate partners in the supply chain. The new system must be implemented without negatively effecting production operations. Serialization cannot result in reduced efficiencies.

    Contract manufacturers have the added challenge of needing to serialize different drug substances and/or drug products for many different clients, each with its own understanding of serialization and related set of expectations. In addition, contract manufacturers do not control the labels that they must use, but have to work within the capabilities of their serialization equipment. It is essential for CDMOs to make sure their customers understand those printing limits to ensure that mandated information is appropriately included on product labels.
     

    In the US, between 2010 and May 2016, close to 1,400 adverse reactions related to counterfeit drugs were reported to FDA.


    Flexible Strategy at UPM

    UPM has always had strict procedures and specifications in place for labeling of drug products. We work closely with our clients and their product management teams to ensure that all labeling is correct and products are branded and otherwise labeled as they are supposed to be. We also have an extensive vendor approval process to ensure there are no mix-ups with labels or diversion of artwork to people trying to produce counterfeit versions.

    When embarking upon our serialization project, we recognized the need to maintain this high level of security while implementing a flexible track-and-trace solution that allows for tailored customer service combined with robust and reliable performance. We wanted to be able to serialize bottles, cartons and cases, without disruption of production while maximizing the capacity on each of our packaging lines.

    Our solution was to adopt an offline serialization strategy. At UPM, our serialization workstations are not associated with a packaging line. This approach provides the greatest amount of flexibility to serve our three packaging lines. Rather than having to set up the packaging equipment for printing, verifying and applying labels that will be serialized during packaging, we preprint the serialized labels/cartons in advance, electronically grading and verifying the information offline, and then apply the labels or fill the cartons during production.

    Serialization offline affords us the flexibility to rapidly respond to customer requests for trial serialization runs. Often smaller customers aren’t confident their labels will have sufficient space. Rather than needing to wait for time to be available on a packaging line, we can conduct trial runs on our offline workstation to determine if a label is ready. Offline serialization also provides the ability to troubleshoot problems without tying up a packaging line. As a result, we are able to maintain production efficiencies and maximize capacities.

    In addition, while UPM selected TraceLink — the world’s largest cloud-based provider of serial codes — as our serialization software partner, TraceLink is capable of working with whichever serialization codes are used by our clients with an interface built between other serial code providers and TraceLink. The transmission of data with TraceLink has proceeded without any issues. Since the link was established, we have consistently received codes and sent them back to TraceLink for commissioning. All lot statuses can be verified on TraceLink’s website once code transmission is complete.

    Cross-Functional Effort

    A core cross-functional team was involved in establishing UPM’s serialization strategy and bringing the project to fruition. Representatives from our information technology, technical service, manufacturing and quality groups formed this core team. The IT department worked closely with the equipment manufacturer and TraceLink to understand all of the system specifications as well as hardware and software requirements needed to manage and maintain our serialization operation.

    Label control is an essential component of pharmaceutical packaging. The addition of a serialization component added another layer of complexity to label control. It was thus determined that a labeling department would be created to control all serialization activities and manage new clients. This department is within the quality assurance group and is responsible for generation of serial codes, generating and issuing serialized labeling, and reconciling completed batches once production is finished.
     

    The first commercial batches serialized by UPM were produced in May 2017 – well ahead of the original November 2017 deadline for unit serialization.


    Staying Ahead of Schedule

    The goal at UPM was to be six months ahead of the regulated implementation date for serialization, allowing for enough time to ensure a seamless serialization process. UPM management was committed to making sure the capital was available to acquire and install the necessary system components ahead of the curve. We also benefited from partnership with a client that used UPM as a beta site before bringing a similar serialization system into its own facility.

    The first commercial batches serialized by UPM were produced in May 2017 — well ahead of the original November 2017 deadline for unit serialization. Despite the one-year extensions granted by FDA, we have remained committed to our timeline for serialization of all batches. We currently meet the requirements that will go into force in November 2018. In addition, we have procedures and processes in place for on-boarding new clients and new products from existing clients, 75% of which we are currently serializing.a

    Conclusion

    Serialization, when used in conjunction with tamper-resistant packaging and other fraud-prevention methods, is expected to provide greatly increased security for the pharmaceutical supply chain. The transparency provided by the ability to trace the movement of a product unit throughout the supply chain, from the manufacturer to the distributor — and on to the patient, should provide a mechanism for the identification of both authentic and questionable medicines.

    We are also building a base of understanding and preparing to respond to the unexpected when it happens. For instance, we have established complaint procedures and validated communications between UPM and our clients. In addition, we are evaluating current solution providers as we look to the next phase of serialization — aggregation. Labeling, including printing, application, verification and aggregation will be required to be done online. We are already preparing for this next level by considering the lessons learned during the first phase of serialization implementation at UPM.

    Reference

    1. “Medicines: Counterfeit Medicines,” Fact sheet. World Health Organization, Jan. 2010. Web.
    2. “Substandard and Falsified Medical Products.” Fact Sheet. World Health Organization. Nov. 2017. Web.
    3. Joe Eaton. “Counterfeit Drugs are Flooding the Nation’s Pharmacies and Hospitals,” AARP Bulletin. May 2016. Web.
    4. Caroline Hroncich. “Serialization Challenges Facing Pharma Manufacturers.” PTSM: Pharmaceutical Technology Sourcing and Management. 12(5). 18 Apr. 2017. Web.
    5. Agnes Shanley. “Tracking Pharma’s Serialization Efforts,” PTSM: Pharmaceutical Technology Sourcing and Management. 11(5). 04 May. 2016. Web.
    6. Gary Lerner, Todd Applebaum, Jim Dougherty. “Serialization in a CMO Environment,” Contract Pharma, June 2012. Web.

  • Experience and Expertise Facilitate Controlled Substance Manufacturing

    Authors: Patrick Hatem and Kim Noll, UPM Pharmaceuticals

    Mar 8, 2017 4:37:31 PM   PAP-Q1-17-CL-004

    Originally published in Pharma’s Almanac Q1 2017.

    Requirements for the manufacture of controlled substances impact all aspects of drug development, manufacturing and distribution. CDMOs that have an in-depth understanding of the regulations, long-standing positive relationships with regulators and a track record of successfully working with controlled substances can accelerate product development and commercialization so that treatments are made available more quickly.

    Preparing for Licensure

    The Controlled Substances Act (CSA) in the U.S. is a federal regulation designed to prevent the diversion of certain potentially harmful substances for illegal use. Various narcotics, stimulants, depressants, hallucinogens and anabolic steroids, including plants, formulated drugs and specific chemicals, are assigned to one of five schedules depending on their medical applicability and potential for creating dependency and being subjected to abuse.

    Schedule I substances are of no medicinal use, have a high potential for abuse and are considered too dangerous to be prescribed to the public. Substances in Schedules II through V (decreasing in potential for abuse) do have medical uses and can be manufactured, tested and distributed in compli- ance with U.S. Drug Enforcement Agency (DEA) regulations. Additionally, there are “listed chemicals” that are chemicals used to manufacture illegal controlled substances and, as such, must be legitimately used in accordance with DEA regulations as well. According to the Congressional Research Service, controlled substances account for approximately 10% of all drug prescriptions written in the U.S. 1

    Manufacturers and distributors of any substances covered by the CSA must be registered with the DEA. Before beginning the licensing process, companies must not only become familiar with the various security and record-keeping requirements, but see that their facilities are fully compliant to ensure control, traceability and accountability. 

    For instance, larger quantities of a Schedule II substance must be stored in a vault in which all six walls are constructed of at least 8” of substantial masonry and the door and frame meet strict design specifications. Large quantities of Schedule III-V substances, on the other hand, can be stored in cages, but the walls and doors must be made out of a certain gauge wire, posts placed according to regulation, etc. Smaller quantities of a scheduled substance can be stored in a safe or steel cabinet, again, as long as certain construction qualifications are met. A record-keeping system must also be in place to provide traceability of any and all controlled substances either coming into or being shipped from the facilities.

    Once it has been confirmed that all of the security and record-keeping systems are in place, the first step is to apply for a State Board of Pharmacy license, which requires completion of the state’s application and on-site inspection. Once that license is received, a company can then submit an application for registration with the DEA. It is also important to note that separate registrations are required for manufacturing, distribution, analytical testing (in specific situations), importing and exporting.

    The Quota System Challenge

    Manufacturers of controlled substances— both active pharmaceutical ingredients (APIs) and formulated products — receive quotas from the DEA that dictate the quantity of controlled substance that can either be made (API) or procured (for use in finished product manufacturing) during a given year. The purpose of quotas is to limit production to the amount required to meet legitimate medical needs.

    By April 1 of each year, those companies wishing to procure controlled substances for manufacturing use must submit their application indicating their quota needs for the following year, including estimates of the quantities of each controlled substance they will produce and raw materials they will use. Manufacturers of bulk controlled substances must submit their quota applications by May 1 of each year.

    From the submitted quota applications, the DEA establishes Aggregate and Procurement Quotas. The Aggregate Quota dictates how much controlled substance can be manufactured in the U.S. Procurement Quotas  establish  the amount of a controlled substance a finished dose manufacturer may purchase for manufacturing use.

    To purchase controlled substances as raw materials (such as an API for production of a formulated product), the purchaser must provide the supplier with its DEA certificate, as well as a Certificate of Available Procurement Quota confirming that it has unused quota available to cover the quantity being purchased.

    If projects come to a contract development and manufacturing organization (CDMO) later in the year, it is possible to apply for quotas for controlled substances at that time. It is also possible to apply for an increase in quota if the assigned quotas turn out to be insufficient. As part of an application for quota increase, a company must provide detailed information as to how the previously granted quota was used, i.e., testing, waste, finished product. It takes approximately four weeks for the DEA to process an application for an increase in quota — a time frame that cannot be accelerated.

    The use of the quota system, with aggregate annual quotas for each controlled substance, in essence results in a fixed market. However, although it can be more difficult for newer products, manufacturers are very good at predicting the quantities needed. To date we are unaware of any time when an aggregate quota was insufficient.

    There can be significant production delays, however, if additional quota must be requested. Perhaps the most challeng- ing situation is the receipt by a formulated drug manufacturer of API that doesn’t meet specifications and must be returned to the supplier. In most cases, the supplier must first apply for additional quota in order to receive the rejected material back into its facility. Then, if unused quota is not sufficient, the drug manufacturer must apply for additional quota in order to receive a new batch of the API. It is a four-week process for both applications, resulting in a possible project delay of eight weeks.

    Managing Reporting Requirements

    Preventing diversion of controlled sub- stances is the main goal of the CSA. Trace- ability and accountability at manufacturing and distribution facilities are the ultimate goals of the control and reporting requirements of the regulation. Extensive record-keeping is therefore essential. Manufacturers can choose to report on a monthly or annual basis. UPM Pharmaceuticals elected to report monthly in order to achieve a higher level of accountability, helping to identify any issues more quickly. For manufacturers, these monthly or annual reports include overall production information — what material came into the plant and how it was used.

    Detailed biannual inventories are also required by the DEA. In these reports, manu- facturers provide a snapshot of all controlled substances currently held under each registration. Year-End Worksheets are also required to be filed by January 31 of each year. Each worksheet acts as a reconciliation of the yearly activity for each controlled substance for which a quota had been granted. A worksheet reflects what was on hand at the end of the previous year, plus all the incoming and outgoing during the reporting year, after which, like a checkbook, everything must balance.

    When seeking contract service providers for projects involving controlled substances, it is essential that sponsor firms select the right partner.

    Choosing the Right CDMO

    The consequences of noncompliance with the regulations of the CSA can be immediate and severe. If the DEA finds evidence of substantial diversion, the agency can order a facility to cease operations immediately. When seeking contract service providers for projects involving controlled substances, it is essential that sponsor firms select the right partner.

    A reliable CDMO will have a long, successful track record of compliance with controlled substance requirements, including meeting reporting requirements. Strong controls, effective handling and maintenance procedures and an excellent record-keeping system are also essential. As important is an in-depth understanding and working knowledge of the regulations and requirements stemming from a long term, positive relationship with the DEA.

    Full-Service Support

    UPM Pharmaceuticals has a long history of manufacturing and distributing many different types of controlled substances. Our highly qualified and experienced personnel have always taken a proactive approach when dealing with the DEA. Our in-house training program ensures that operators and other employees who handle controlled substances understand the importance of following company procedures to ensure compliance with the CSA and avoidance of any diversion of controlled substances.

    As a client-focused CDMO, UPM is vested in providing more than just capacity for the production of controlled substances. We work closely with our customers to make sure they understand all aspects and implications of the CSA. In addition, with an analytical laboratory approved to handle Schedule I-V controlled substances and listed chemicals, we can sup- port our clients with formulation development and stability/degradation testing. Our R&D group also investigates abuse deterrence solutions for controlled sub- stances that both DEA and the U.S. Food  & Drug Administration have interest in.

    The ability to support controlled substance projects in-house from the proof of concept stage through to commercialization/product launch, including formulation development, process and method development, validation and warehousing, does away with the need for technology transfer of these challenging projects off-site to other vendors. Clients save both time and money while getting their products into the hands of patients more quickly.

    Conclusion

    When dealing with controlled substances, avoiding diversion through the use of appropriate controls and record-keeping is absolutely crucial. Sponsor firms need to identify reliable CDMO partners with a proactive approach to managing controlled substance projects and a successful history of completing them.

    References

    1. Yeh, Brian T. The Controlled Substances Act: Regulatory Requirements. Rep. Congressional Research Service. 13 Dec. 2012. Web.
  • Designing Effective Drug Formulations: Keys to Successful Proof of Concept Services

    Author: Ed Scholtz, Ph.D., UPM Pharmaceuticals

    Oct 1, 2016 12:00:00 PM   PAP-Q04-16-CL-004

    Originally published in Pharma’s Almanac Q4 2016.

    Increasing API complexity has created a need for innovative formulation solutions. To rapidly reach the formulation proof of concept stage, pharmaceutical companies frequently rely on outsourcing partners with extensive formulation development experience. Because the goal is  commercialization, however, many sponsors prefer to work with contract development and manufacturing organizations (CDMOs) that can readily scale those proven formulations.

    A comprehensive understanding of the properties of a drug substance — its solubility in solvents and buffer systems, compatibility with excipients, stability under different physiological conditions, solid-state characteristics, basic physicochemical properties, etc. — is necessary to select the most effective drug-delivery system and develop an optimal drug formulation, particularly for challenging and complex compounds that suffer from poor solubility or are highly potent. Preformulation studies offered as part of proof-of-concept services are designed to fully characterize the API and determine the dosage form and drug delivery system that will provide a safe, stable drug product with high efficacy.

    Thorough preformulation studies can, however, be quite costly. Drug manufacturers are seeking service providers that can apply extensive experience with a broad array of compounds/chemistries to the design of comprehensive preformulation studies that include only relevant tests, as well as the selection of appropriate formulation technologies with the greatest potential for success. 

    Outsourcing to CDMOs that can take a project from the proof of concept stage all the way through to commercialization, thus eliminating the risk, time and cost associated with technology transfer and the need to manage multiple suppliers, is also increasing. Preferred service partners also continually invest in new equipment and facilities, provide dedicated project management support with personalized service, offer real manufacturing flexibility and focus on meeting customer milestones.

    A strong development history

    UPM Pharmaceuticals was founded as a formulation development company and has been providing development services for over 15 years. The company focuses on solid and semi-solid formulations and has extensive experience with many different types of APIs and solid/semi-solid dosage forms. 

    Once a project contract has been approved, UPM forms a dedicated project team that meets with the customer to understand the project goals and gather any available information on the API. These teams consist largely of scientists with Ph.D. or MS degrees that are extremely knowledgeable and focused on formulation science. They identify the analyses required to determine additional necessary information, and based on the obtained results, excipients and formulation/delivery technologies are suggested to the client. 

    Comparability studies using material prepared in minibatches (50- to 100-g scale) are then performed. Head-to-head comparisons of formulations that have different ingredients (except the API) help to quickly identify stable formulations. Throughout this process there is close cooperation between the analytical and development groups, which allows for the engineering of the optimum formulation that can be directly scaled to GMP clinical and commercial production.

    Ongoing provision of innovative drug development and manufacturing solutions requires continual investment in advanced technologies, equipment and facilities.

    Continued investment

    Ongoing provision of innovative drug development and manufacturing solutions requires continual investment in advanced technologies, equipment and facilities. Recognizing the need of pharmaceutical customers for more rapid and cost-effective proof of concept services combined with GMP production capabilities, UPM moved from its original location in Baltimore, Maryland to a previous Pfizer manufacturing site in Bristol, Tennessee and invested over $12 million to expand production suites and modernize the facility, plus over $1 million to create a Solids Formulation R&D Facility. 

    The R&D facility includes a GLP laboratory with dedicated small-scale, state-of-the-art equipment identical to that used for GMP production of clinical and commercial material, allowing for easy scale-up. Capabilities include wet and dry granulation, particle size reduction, encapsulation, bi-layer tableting, granules and coating. HEPA filters, down-flow hoods, glove boxes, soft enclosures, advanced personnel protective equipment and a gowning room enable the handling of highly potent compounds. Three analytical laboratories for raw material, test method development, and in-process material and product testing provide support to the development lab. The facility also includes a dedicated R&D raw material warehouse and space for in-process material (with refrigerator/freezer capability and airflow, temperature and humidity controls) and equipment storage. Onsite maintenance support reduces the risk of equipment failure and project delays.

    Direct scalability

    The new Solids Formulation R&D Facility offers UPM clients several advantages. First, very small batches using 50 to a few hundred grams can be processed in the mini-scale equipment, allowing a large number of runs to be performed without consuming large quantities of expensive API that may be in limited supply. Secondly, because the equipment is the same as that used for clinical and commercial manufacturing, scale-up is facilitated, leading to both time and cost savings.

    UPM’s trademarked BREVI-BATCH® processing platform for solid dose mini-scale R&D formulation development targets batch sizes of 100 – 500 grams, a much smaller scale than typically found in R&D formulation development laboratories. In addition, the equipment is designed for easy setup, use and cleanup, and is small enough to allow processing of highly potent compounds under containment conditions.

    During the formulation development process, approximately 10 mini-batches are run, with scalability and the availability and cost of raw materials considered from the initial formulation design stage. Notably, in some cases, batches can be run using as little as 25-50 grams of API. Use of the BREVI-BATCH® processing platform allows UPM customers to reduce the cost and time required to successfully complete the formulation development and proof of concept stages − increasing the likelihood of commercializing effective and innovative medicines and getting them to patients sooner.

    UPM’s trademarked BREVI-BATCH® processing platform for solid dose mini-scale R&D formulation development targets batch sizes of 100 – 500 grams, a much smaller scale than typically found in R&D formulation development laboratories.

    Dedicated project management

    Effective project management is essential for achieving the smooth progression of a project through the proof of concept stage, onward through clinical material production, and ultimately into commercial manufacture. At UPM, project managers are selected not only for their technical knowledge and expertise, but also the ability to effectively communicate and collaborate. Managers adopt an ownership approach and, along with the entire project team, stay with a project from the kickoff meeting through formulation development, proof of concept and all the way to commercialization. 

    Manufacturing flexibility

    UPM recognizes that the drug development process is unpredictable and the unexpected should always be expected. Accordingly, we have built in flexibility for addressing the challenges that arise. With daily scheduling meetings, UPM is able to quickly respond to changing client and market needs. We also have the operational capability to respond to unexpected manufacturing issues.

    Technical flexibility is also essential for developing effective, safe, robust formulation solutions for the challenging drug candidates moving through the pharmaceutical pipeline today. UPM has extensive experience in drug delivery technologies that are appropriate for solid and semi-solid dosage forms. For those clients that wish to run phase I studies using capsules containing neat API, we have substantial capability for meeting their needs with four specialized filling machines. In our R&D facility, we also have a small-scale packaging line for bottles and can perform manual packaging processes for the production of 10-20 bottles for various studies. Plans are in place to install a small-scale blister packaging line as well.

    Personalized service

    Along with manufacturing flexibility, personalized service is highly valued by pharmaceutical companies looking for innovative formulation solutions for their complex and challenging APIs. Although a smaller CDMO, UPM is closer to larger, integrated service providers, offering not only proof of concept services, but also clinical and commercial manufacturing support — but with the personalized, responsive service of a well-funded, family-owned organization that emphasizes customer service and satisfaction.

    In fact, UPM customers are treated like family too, with project teams operating as extensions of their businesses. Both team leaders and team members take a high interest in projects. Face-to-face interactions are a key component of our relationships with our pharmaceutical partners. President and CEO James E. Gregory is accessible to clients and very engaged with the business and concerned about meeting customer needs for the rapid development of high-quality, cost-effective, innovative formulations and delivery solutions.

    Meeting milestones

    While clients recognize that formulation development and scale-up to clinical and commercial manufacturing rarely proceeds without some unexpected challenges, they still expect projects to be completed on time. The most successful CDMOs offering proof of concept services have a track record of consistently meeting client milestones on time and within budget. UPM is one such service provider. We focus on deliverables: meeting customer milestone timelines, such as for producing high-quality, on-spec clinical supply materials and completing regulatory filings. That means performing the work that needs to be done to move projects forward as rapidly and smoothly as possible.

    UPM’s dedicated team of technical and manufacturing experts have nurtured projects starting from the proof of concept stage, clearly demonstrating our extensive expertise in early-stage formulation development and commercial production for solid and semi-solid oral dosage drugs, including immediate and controlled release products.