Xcelience, LLC
Xcelience, LLC
Headquarters
Tampa, Florida
Location(s)
Tampa, Florida
Years in Drug Formulation
11 Years
Spokesperson
Randall Guthrie, Vice President
https://www.xcelience.com
| Areas of research | |||||||
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Small Molecule |
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Biological |
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Other | ||
| Drug Formulation Services Offered | ||||
| • | Analytical method development | • | Bioavailability enhancement | |
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Compatibility studies of active ingredients |
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Dosage form selection | |
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Excipient compatibility |
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Formulation optimization | |
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Formulation stress testing |
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in silico studies | |
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Manufacture of clinical supplies |
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Novel delivery system | |
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Packaging compatibility assessment |
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Particle size reduction | |
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Preclinical studies |
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Solubilizing water-insoluble drugs | |
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Stability studies |
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Taste masking/flavorings | |
| Other Services Offered | ||||
| Disease Research | Target Identification | |||
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Lead Identification |
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Early Safety Tests | |
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Lead Optimization |
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Pre-clinical Studies | |
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IND Submission |
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Clinical Trials | |
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NDA Submission |
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Post-marketing Studies | |
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OTHER |
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| Types of Drugs | |||||||
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Generics |
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Prescription |
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OTC | ||
| Dosage Forms | ||||
| • | Capsules | Implantable | ||
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Inhalation |
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Injectible | |
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Oral |
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Parenteral | |
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Peptide and Protein |
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Tablets | |
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Topical |
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OTHER | |
Company’s role in drug discovery and developmnet
Xcelience, LLC provides formulation development and clinical supplies manufacturing solutions to virtual, emerging, and large pharmaceutical companies. We combine a commitment to quality and decades of experience in advancing the development of new chemical entities from pre-IND to commercialization. Our state-of-the-art equipment enables small molecule-focused pharmaceutical companies to accelerate drug development programs and meet critical product and financial milestones. Services include preformulation, formulation development, analytical method development and validation, clinical trial supplies manufacturing, packaging and labeling, and dosage form stability studies. We add innovative technology where it makes sense to meet client goals.
Company’s experience and expertise in drug formulation
Xcelience is a privately held company built on a strong foundation of quality and scientific expertise, with a proven ability to deliver high-quality results that enable pharmaceutical companies to meet important program and financial milestones. Core areas of expertise include preformulation services (polymorph screens, salt screens, drug substance characterization), dosage form development (solids, semi-solids, and liquids), analytical method development and validation, and clinical supplies manufacturing, packaging, and labeling. Xcelience continues to be the most experienced provider of API into capsule having worked with more than 30 APIs and seventy batches utilizing the Xcelodose precision powder micro-dosing system (Xcelodose is a registered product of Capsugel, a division of Pfizer).
Relationship with pharma companies
Xcelience is a contract service provider. Our ideal project is one where we partner early with a pharmaceutical company who needs our full breadth of services. This company may know very little about their drug substance. They seek information from preformulation studies to improve compound knowledge and this information enables them to make choices and identify one or two drug discovery candidates. As they proceed from toxicology studies into clinical trials, pharmaceutical companies may elect dosage form development and clinical supplies manufacturing services, or they may elect to fill their active pharmaceutical ingredient (API) directly into capsules. Analytical method development and stability studies naturally accompany these services. Large pharmaceutical companies with deep scientific capabilities and drug development expertise may also find value with Xcelience, utilizing our services to access technical expertise or to manage capacity overflow.
Factors critical for drug formulation
Xcelience is committed to providing solutions that address real customer needs, such as speed to a specific endpoint, ability to overcome challenging molecular properties, or limited active pharmaceutical ingredient (API). Pharmaceutical companies face demands of accelerated timelines and financial pressures, and seek outsourcing partners with the expertise and ability to provide a variety of dosage-form options, including active pharmaceutical ingredient (API) into capsule, powder in bottle, liquid in capsule and binary blends. For companies facing the challenge of limited API, Xcelience recently expanded GMP manufacturing capabilities with the purchase of three pieces of equipment that enable small scale batch production.
Scientific/business/regulatory trends impacting drug formulation
An overriding trend is companies trying to do more with less. Faced with stakeholder and financial pressures, companies seek an accelerated path to Phase 1, but expect to get there with less active pharmaceutical ingredient (API) and challenging molecular properties (poor solubility). This has spurred the development of numerous programs detailing a fast path to first-in-man studies, each with unique critical assumptions and requirements. At Xcelience, API-into capsule utilizing the Xcelodose precision powder micro-dosing system is just one of the solutions available to address this need (Xcelodose is a registered product of Capsugel, a division of Pfizer).
Certainly every firm is affected by the current economy. While large pharma may focus on retaining shareholder value, emerging pharma may struggle with funding. Companies are careful with spend, and risk mitigation for smaller firms may mean breaking projects into segments. QBD guidance requires firms to identify critical parameters and define design space, driving the need for efficient pre-commercialization services. Outsourcing providers with proven abilities to help companies navigate scientific, regulatory, and funding challenges have a bright future. “Providers, like Xcelience, that understand early stage development, deliver proven programs that accelerate development, and offer flexible partnership bring added value in challenging times” says Guthrie.
Success story
Due to client confidentiality, company names cannot be mentioned, but generic success stories emphasize our flexibility in working with clients to create tailored solutions that enable them to accelerate development, meet critical milestones, or manage capacity. We have seen scenarios where a timetable has slipped due to difficulty with in-house formulation or analytical method development efforts, or simply due to double-booked capacity with a different vendor. Understanding the intense pressure to meet IND-filing deadlines, Xcelience has been able meet with clients to develop a step-by-step plan and quickly mobilize a project team. Having an experienced staff and dedicated project management function are two key elements that contribute to our ability to back up these commitments. For companies that experience ebbs and flows to their in-house capacity, Xcelience has worked with clients to devise full time equivalent (FTE) programs, enabling them to rely on a core group of personnel as an outsourced resource, with the option and flexibility to increase headcount during peak project periods.
How will roles of CROs and contract manufacturers change over the next few years?
Economic pressures and regulatory considerations drive the need to find the right outsourcing partner, one that delivers value at the solutions level, in addition to meeting capability/capacity requirements. The future looks bright for trusted partners, like Xcelience, who can build solutions to mitigate risk and do more with less.
Filed Under: Drug Discovery
