Why Catalent for Emerging Biotech?
Successful new treatments are built on biopharmaceutical science and the art of building a successful new biotech able to bring them to patients.
Hiring the right talent and securing the right mix of clinical, development, and manufacturing partners is vital to hitting all the milestones along the way.
Through our broad capabilities and vast experience of working with hundreds of emerging biotechs, we will tailor solutions that accelerate your timelines, from pre-clinical and first-in-human studies to developing CMC strategies to seamlessly scaling for a successful launch.
Catalent can be your one development and manufacturing partner, helping to simplify and de-risk your program with integrated solutions, deepest development expertise, broadest portfolio of drug delivery technologies and manufacturing platforms across modalities.
Let’s accelerate together!
Summary: In this eBook, learn more about strategies that successful emerging biopharma and biotech companies have used to move their discovery to market.
Summary: Every clinical study is different, each with its own unique characteristics and requirements. The optimal time to begin planning a clinical supply strategy is while the study…
Summary: A well-known, mid-size, multi-national pharmaceutical company needed a large supply of comparator drug, in order to begin comparative clinical trials for a rare disease. In addition to quantity, the comparator drug must have an expiry-term long enough for the client to complete the multi-year clinical trials…
Achieving Faster Timelines and Higher Titer in Antibody Expression When Combining GPEx® Cell Line Development Technology with the Beacon® Platform for Clonal Cell Line Selection
Summary: This case study explores Catalent’s unique GPEx® technology for stable gene product expression with Berkeley Lights, Inc.’s (BLI) Beacon® instrument for clonal selection.
Learn how a biopharmaceutical company partnered with Catalent to develop and manufacture a commercially-viable, patient-friendly, stable tablet for a program intended to treat a disease that has unmet medical need.
Learn what clinical sponsors should look for when assessing integrated services and potential providers.
While clinical studies are in Phase 2, it is important for sponsors to be prepared for any Phase 3 challenges that might arise. Understanding what resources are available is key to being ready for Phase 3 before it even begins.
Summary: In this executive summary, industry experts share case studies of how they’ve adapted to increasingly expedited regulatory reviews.
Summary: As the need for accelerated biopharmaceutical development around the world continues to grow, companies are facing complex challenges that need to be overcome to remain competitive for increasing process productivity…
Summary: A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. With the protocol based…
Summary: MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds. Learn how Catalent provided integrated formulation…
Select the most suitable formulation technology to enhance the molecule’s bioavailability.
Quality by Design (QbD) is well established in the pharmaceutical industry for manufacturing processes, including active pharmaceutical ingredients and drug products.
Read this case study to learn how a team of bioavailability experts at Catalent took a target molecule from early stage to Phase 1 in under nine months.
Read this case study to learn about how Catalent deployed its integrated OneXpress® Solution to expedite the transfer of a partner program to one of its late-stage manufacturing sites while optimizing the utilization of a limited supply of API.
Why Formulation Technologies are Critical to the Success of the Next Generation of Small Molecule Oral Drugs
By taking advantage of modern screening technologies to collect and leverage molecular data early on, drug developers can bridge the gap between molecule discovery and dose form selection.
This eBook is a selection of articles published in the Journal of Drug Delivery Science and Technology, giving overviews on different types of strategies that are used to increase the dissolution rates of poorly water-soluble drugs in order to increase their bioavailability.
Developing Optimal Formulations Using Biorelevant Predictive Tools and Advanced Bioavailability Enhancement Technologies
API-sparing development techniques and identification of the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success when moving from preclinical development to early phase clinical trials.
Strategic analytical partnerships are important in the development of new pharmaceutical products, especially biologics. In this article, experts discuss the growing need for partners who can provide niche technologies to accelerate development projects.
With increased focus and efforts on developing treatments for diseases with smaller patient populations, diseases for which there are no currently approved treatments, and diseases that have historically not prioritized by the pharma industry. Accelerating the approval process offers significant benefits, but the reduced timelines can create significant challenges.
This eBook will explore how to drive excellence within the forecasting process and how to utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines and to identify potential supply-related issues before they negatively impact your study.
Learn how to leverage the drug development knowledge and build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process.
While accelerated development programs are intense by design, few have a similar regulatory experience—particularly when it comes to Breakthrough Therapy Designation (BTD).
Understanding and planning for phase-appropriate CMC-related activities can facilitate the transition from early development through commercialization.
Summary: Experts discuss the changing experience from the last quarter of a century in the pathway to patients, and how the latest advanced technologies translate into effective pre-clinical and clinical development and manufacturing.
Summary: In this webinar a group of experienced cancer drug developers discusses key strategies in managing an orphan drug program.
This article explores the benefits of a more integrated approach in which the chemistry, manufacturing, and controls (CMC) teams and clinical teams work together at an early stage to achieve greater success for both the development program and patients.
In this executive summary, learn the important details to consider when selecting a clinical supply partner in early phase studies that can have longer term implications during late phase.
While the first autologous cell therapy commercial products have shown tremendous clinical success, scaling out these therapies while considering individual patient processes is a new challenge.
As pharma companies look more and more to biologics for their next potential blockbusters, they must face the challenges surrounding these products’ scientific complexity and sophisticated development.
This article explores the biologics landscape, market insights and trends, and provides future projections for what the global biologics market, including cell and gene therapy, will look like over the coming years.
This ebook discusses efficiencies specific to early biopharmaceutical formulation development and biomanufacturing continuous processing.
This executive summary discusses imperative that companies invest adequate time and resources in strategic planning and preparation activities to ensure the best chances for a successful commercial launch.
Summary: Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact how a drug compound…
How can decisions made during the preclinical phase of drug development increase the chances of a product’s eventual success in a difficult marketplace?
How can a patient-centric outlook help scientists tackle the key challenges of early drug development.
Utilize an all-encompassing approach to enable an effective dosage form faster to market.
Summary: Three early drug development experts present insights and techniques to help your clients get their molecules from preclinical to Phase 1 studies.