INDUSTRY INSIGHTS

• Leveraging Integrated Electronic Laboratory Notebook And Inventory Systems

  Integrating lab notebooks with inventory and asset tracking boosts accuracy and traceability. Real-time visibility cuts errors, speeds decisions, and supports compliant, scalable pharma development.

• Why CDMO Performance Drops Exactly When It Matters Most

  Programs often stall moving to GMP due to fragmented workflows and knowledge gaps. Aligning teams and integrating development with execution, via continuous data, sustains momentum and reduces risk.

• Gaining A Competitive Edge Through Regulatory Compliance Confidence

  Achieving regulatory compliance confidence is paramount for safety and competitive advantage. Adherence to standards and robust risk mitigation are essential to avoid delays and detrimental outcomes.

• Science To Success: CMC Strategies That Drive Market Readiness

  Learn how a scientifically grounded framework for early-phase CMC development, integrating QbD and proactive risk management, helps de-risk drug development and accelerate the journey from molecule to market.

• API In Capsule Vs. The Lost Art Of Formulation Development

  API-in-capsule offers a fast path for early clinical data, but it can't eliminate the need for full formulation development. Weighing the potential for higher total development time and cost is critical.

• Small Molecule Oral Delivery For Rare Diseases: Complexities As A CDMO

  Developing therapies for rare diseases faces hurdles like high costs, small patient populations, and complex small-batch manufacturing. CDMOs offer crucial support, expertise, and flexibility.

• Spray Dried Dispersions In Controlled Release Formulations

  Integrating spray dried dispersions with CR strategies addresses poor drug solubility and the need for tailored release kinetics. Explore considerations to ensure stability and sustained supersaturation.

• Strategic Approaches To Controlled Release Formulation: Polymer Screening And Case Study Insights

  Discover how early polymer selection drives formulation success, with case studies linking polymer choice to drug release and practical insights for developing robust CR products.

• Site Transfer Of Tablet Production From Ex-U.S. To Georgia Site

  Explore how strategic U.S.-based manufacturing and supply chain diversification can reduce risk, lower costs, and enhance supply reliability for pharmaceutical products.

• Modifying The Micro-Environment To Improve Dissolution Rate

  Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

• Risk Mitigation For Late-Stage Clinical Assets

  Leveraging the competence and capabilities of the CDMO to bring forth innovative, flexible solutions to safeguard supply chains for their clients and, ultimately, for patients is crucial to strategic partnering.

• Bend Successfully Rescues Powder-Filled Capsule Program

  Learn how to overcome tech transfer challenges and ensure consistent content uniformity by leveraging multidisciplinary expertise and decades of commercial encapsulation experience.

• Spray Dried Dispersions: Performance, Manufacturability, Stability

  Explore advanced approaches to designing robust amorphous formulations and optimizing spray drying processes tailored specifically to difficult-to-formulate compounds.

• Transforming A Liquid Protein Solution Into A Solid Oral Dosage Form

  Unlocking the potential of oral protein therapeutics requires innovative formulation and manufacturing strategies to overcome stability, absorption, and bioavailability challenges.

• Molecular Properties Of PROTACs And The Relationship To Formulation Design

  Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.

• How To Choose The Right CDMO For Your Pharmaceutical Project- Part One: Will They Deliver?

  Choosing the right CDMO is crucial for the success of your pharmaceutical project. Learn how to strike the ideal balance between an organization's technical expertise, facilities, and efficiency.

• Navigating OSD Formulation Development And Leveraging CDMO Partnership

  Collaborating with an experienced CDMO can provide the expertise and facilities needed to navigate oral solid dose formulation complexities and ensure compliance with regulatory frameworks.

• Early Development Considerations For NCE Success: Quality Systems

  Leveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.

• Modified Release Formulations: Extending Drug Commercial Lifecycle

  A CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.

• Early Development Considerations For Late-Stage NCE Success – Part Two

  Discover how strategic partnerships, robust process development, and a keen awareness of supply chain vulnerabilities can pave the way to a successful clinical trial.

• Early Development Considerations For Late-Stage NCE Success – Part One

  Navigating NCE development can be daunting. Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for success.

• What Information Does A CDMO Need To Deliver A Good Proposal?

  Learn about the importance of sharing as much information as possible with your CDMO and how asking the right set of questions will ensure that services are fairly priced and timelines are accurate.

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• Key Pillar Of A Successful CDMO: Exceptional Regulatory Compliance

  Ensuring regulatory compliance is paramount for a CDMO to meet manufacturing standards, warrant patient safety, and maintain its reputation.

• Over The Hurdles: Taking Psychedelics From Schedule I To Pharmacy

  Learn how a partner with experience in handling scheduled substances and navigating FDA and DEA regulation can help you advance toward clinical research and drug development with ease.

• Tapping Into The Unexplored Through 505(b)(2) Pathway

  Leveraging the the 505(b)(2) regulatory pathway can enable an accelerated approval timeline and help advance your drug product to market. Review the three statutes that govern the approval pathways.

• The Right Polymers For Your Modified Release Multiparticulate Capsule

  Pharma companies aiming to tech transfer or scale-up modified release formulations often encounter hurdles when the formulation is not robust. Review how to select the right polymers and ensure you have a robust formulation strategy.

• Navigating The Pharma Supply Chain: Balancing Risk And Resilience

  Leveraging an experienced partner with a robust supply strategy can help manage the strain of a supply chain in flux and mitigate risk during the development and manufacturing processes.

• Choosing The Right Clinical Trial Packaging Partner: 5 Cs To Consider

  Today’s clinical studies demand flexible clinical trial services (CTS). Knowing what to look for when evaluating a CDMO can help avoid delays and ensure your product advances to market on schedule.

• Don't Skip Preformulation: Your Blueprint For Drug Development Success

  Investing in the right preformulation studies and gathering evidence to inform decisions is critical to identify product dead-ends and failure modes without the pain of hindsight.

• Managing The Challenges Of A Successful Commercial Tech Transfer

  View the webinar to uncover common issues that impact commercial tech transfers and hear experts share key points for building a seamless partnership between the client and outsourcing partner.

• What is a CDMO?

  As you bring a new drug product to market, leveraging the expertise and technical capabilities of a CDMO can help reduce costs and streamline processes on the path to commercialization.

• People And Culture Drive Operational Excellence

  While improving processes and eliminating waste may provide short-term gains, the true key to sustainable improvement lies in addressing the culture and employees within the organization.

• Reformulation Of A Complex, High-Drug-Load, Modified Release Dosage Form

  What if you could limit and position a formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance?

• Making The Right Choice For Multiparticulate Modified Release Dosage Forms

  Wurster processing is a versatile pharmaceutical development and manufacturing technique for multiparticulates in modified release dosage forms. Understand if it's the right method for your modified-release project.

• How To Avoid Last Minute CMC Roadblocks To Approval

  Get a brief overview of the CMC information required by regulatory authorities and why planning and budgeting for key CMC considerations early in the development process are essential for success.

• An Approach To Proactive Improvement In Established QC Lab Processes

  Proactively uncovering issues and resolving human errors to avoid defects is a priority. Learn about a reliable, systematic, data-gathering approach that helps build efficiencies and future-proof processes.

• Achieve Release Profiles And Select Excipients For Formulation Development

  The formulation and manufacture of modified-release OSD forms are highly specialized. Review considerations for planning and executing a successful modified release oral solid dosage formulation.

• Optimizing Operations In Multiproduct Pharma Manufacturing Facilities

  Explore some of the key features that pharmaceutical companies should look for in the facilities of prospective manufacturing partners.

• Opioid Reformulation Filed As A CMC Supplement In Less Than A Year

  Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.

• Choosing A Formulation And Process Approach To OCR Products

  Do you want to develop an oral controlled release (OCR) product? Understand the options and their ramifications as the first step toward devising a plan.

• How An Outsourcing Partner Can Deliver Efficient Serialization Solutions

  Are you serialization-ready? Failure to comply could result in penalties and the inability to sell your un-serialized products.