Frequently-Asked Questions

     

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    Capabilities

    What containers can you aseptic fill/finish?

     

    What services does Exelead provide?

     

    What is an engineering batch?

     

    How does the engineering batch benefit the customer?

    What does Exelead’s R&D investment for LNP-related services look like?

     

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    Our Process

    How does Exelead handle data sharing with clients? 

     

    Does Exelead support person-in-plant for development?

     

    How does Exelead select vendors for raw materials?

     

    How are project teams organized for development and technology transfer?

     

    How does technology transfer work?

     

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    General

    How many liposomal and LNP projects does Exelead have ongoing?

     

    How is Exelead different from other Contract Development and Manufacturing Organizations (CDMOs)?

     

    What is the role of a process engineer?

     

    What are LNPs?

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    Capabilities


    What containers can you aseptic fill/finish?

    We currently provide aseptic fill/finish for both glass and plastic vials.

     

     

    What services does Exelead provide?

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    Casey Mihal, Process Engineer

    We offer formulation development, project management, method development & transfer, process development, technology transfer, clinical manufacturing, process sale up & optimization, commercial manufacturing, CMC support, aseptic fill/finish, packaging & inspection, lyophilization, supply chain management and quality control testing (raw material, in-process, finished product, sterility and stability testing).

     

    Have you been involved in co-development for LNP Related Drug Product therapies?

     

    Exelead is not interested in owning intellectual property for the drugs we manufacture. However, Exelead considers each of our clients our partners and their patients as our patients. As such, there are currently 11 LNP projects being executed at Exelead (pre-clinical through clinical).

     

     

    What is an engineering batch?

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    Benjamin King, Formulation Scientist

    An engineering batch cannot be used in patients, but it allows us to perform method qualification and sterile filter qualification. Running an engineering batch is good practice for our formulations and fill room operators, because it allows them to simulate the final GMP process. During an engineering batch, our team walks through the process and makes hand corrections on the batch record to ensure everything is perfect before we proceed to GMP manufacturing for a clinical batch.

     

     

    How does the engineering batch benefit the customer?

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    Nate Milton, Senior Scientist

    The core purpose of an engineering batch is to reduce risk for our customers. We manufacture a final test batch to ensure the process and product are flawless. The engineering batch gives us one last chance to adjust the process before the transition to clinical manufacturing.

     

     

    What does Exelead’s R&D investment for LNP-related services look like?

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    Tracey Froggatt, Manager, Supplier Quality and Site Compliance

    A $25 million (USD) expansion project has begun at the site to increase the LNP formulation capacity by 33% and fill capacity by 100%. The new filling space will be available for Clinical and Commercial use in Q4 2020. This will result in 4 rooms capable of liposomal manufacturing, and a new development laboratory for larger-scale pre-clinical development work. The teams assigned to these areas will work side by side with our method development team to improve efficiency in testing and characterization of the process and product.

     

    Exelead has added and continues to add PhD level employees to participate in Technology Transfers to support Process and Analytical Method Development.

     

     

    Our Process


    How does Exelead handle data sharing and project updates for clients? 

    Your assigned Exelead Project Manager will be the single point of contact and will be copied on each correspondence, email or otherwise. Your PM will grant your team access to a client-dedicated ShareDrive account in order to access reports, data, etc.

     

     

    Does Exelead support person-in-plant for development?

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    Casey Mihal, Process Engineer

    Exelead encourages our clients to send a support team for the early parts of the knowledge transfer. This allows our engineers and support staff to learn from the experts and speak face-to-face; which, historically, has led to quicker success. Typically, this relationship is specified in the proposal, Quality Agreement, or Supply Agreement.

     

    Your team will be granted access to our facilities up through the engineering batch. After clinical or commercial GMP batch manufacturing has begun for your drug product, only qualified personnel will be permitted to enter the areas of the facility where your drug is manufactured.

     

    At our Indianapolis facility, we also maintain a private space for our potential clients to work and gather when not in meetings.

     

     

    How does Exelead select vendors for raw materials?

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    Tracey Froggatt, Manager, Supplier Quality and Site Compliance

    Vendors that supply material to be used in the manufacture of commercial material at our site must be qualified by the Supplier Quality Auditors. For late-stage clinical and commercial products, we send own team to the vendor/supplier's site on a regularly scheduled basis to evaluate their quality systems.

     

    We have long-standing relationships with a number of lipid suppliers, including Avanti Polar Lipids, NOF and Lipoid; however, we are happy to source lipids or other raw materials from your recommended suppliers.

     

     

    How are Exelead’s project teams organized in regards to development and technology transfer?

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    Benjamin king, formulation scientist

    One of the first deliverables after a contract has been signed is a team list and communication plan, drafted by the Project Manager. Project teams are assembled based on project requirements. 

     

    Clients are also assigned a process engineer—who is dedicated to their process for the full life cycle of their product—and a quality product representative, who serves as the point of contact for quality-related discussion.

     

     

    How does tech transfer work?

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    Rahul Keswani, Senior Formulation Scientist, Group Leader

    Tech transfer is a movement from lab to manufacturing. Our team helps to de-risk the entire process—fine-tuning the parameters and specifications—to ensure that we are able to provide a quality finished drug product.


    Especially in a CGMP environment, a lot of studies need to be done in the early stages of drug development. Before a drug product is ready for manufacturing, we take the client's existing ideas or existing processes and modify or further develop them to improve conditions under which the product will be made.

     

     

    General


    How many liposomal and LNP projects does Exelead have ongoing? 

    Exelead currently supports 15 ongoing liposomal and LNP projects across preclinical, clinical and commercial.

     

     

    What differentiates Exelead from other contract development and manufacturing organizations?

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    Mahesh Karwa, Senior Manager, Analytical Technical Services

    We manufacture commercial drug products for global distribution. This means our facility is approved by global regulatory agencies for manufacturing and distribution of products. We are regularly audited and remain in excellent standing with these groups.

     

    Exelead is a full-service CDMO. Our services encompass everything from raw material procurement and supplier qualification to release and shipment of fully-packaged, finished drug product. Offering these services all on one campus allows us to simplify supply chains and better control the quality of your drug product. 

     

    During the entire 25+ years we have been manufacturing drug product at our Indianapolis manufacturing site, we have always focused on two core technologies: lipid-based formulations and pegylation. We have strategically placed ourselves as a niche pharmaceutical company, providing end-to-end service for clients that operate in this market. Because we maintain integrity to this focus, we continue to operate as industry experts. Our experience in these areas is what allows us to optimize, monitor, and meet product CQAs with a high level of control.   

     

    We are constantly working to expand our capabilities to better serve clients in the rare disease market. With an eye on the future, we are currently investing in a multi-million-dollar capital expansion project to increase our development, formulation, and aseptic fill/finish capabilities.

    This expansion project will be used primarily to grow our formulation and filling space, which can be used for development, clinical, and commercial products. The new GMP areas, which are expected to be ready for use in Q4 2019, will facilitate more efficient manufacturing operations and increase site capacity.

     

     

    What is the role of a process engineer?

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    Tracey Froggatt, Manager, Supplier Quality and Site Compliance

    Exelead's process engineers help to take drug candidates from a lab-scale environment to a closed-system cGMP manufacturing environment that conforms to FDA requirements. One important role a process engineer plays is designing and determining the right equipment to support a customer’s process.

     

     

    What are LNPs?

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    Mahesh Karwa, Senior Manager, Analytical Technical Services

    LNP stands for lipid nanoparticle. Think of LNPs as lipid bubbles designed to encapsulate a specific drug that would otherwise become unstable in the body. They protect the active pharmaceutical ingredient until it reaches its intended site of activity.