INDUSTRY INSIGHTS

• Fewer Setbacks, Faster To IND

  Cy Credille, Group Leader in process chemistry at Cambrex Longmont, on the setbacks that come as standard in early development — and why a team that has seen them all before is the fastest route to the IND finish line.

• Ask Us Anything: Eric Fang On Lithiation Chemistry

  Eric Fang, General Manager of Snapdragon Chemistry, on why lithiation chemistry resists batch scale-up — and how a decade spent understanding static mixing lets Snapdragon carry these reactions from milligrams to metric tons.

• Solutions For Overcoming New Challenges In Pharmaceutical Development

  Eric Fang on meeting new pharmaceutical development challenges with a two-part investment — technology that answers R&D questions faster, and scientists given the support to tackle what technology can't.

• Revolutionizing The Development, Characterization, And Manufacturing Of Peptides

  Erik Feldmann, Technical Director, on the analytical challenges of proteins, peptides, and oligonucleotides — and why he starts every method-development problem by understanding what the customer is trying to achieve.

• How Is Peptide Crystallization Screening Used In Peptide-Based Therapeutic Development?

  Hannah McLachlan, Project Scientist IV at Cambrex Edinburgh, on what crystallization screening delivers for peptide therapeutics — more stable material, higher purity, and a molecule clients can store without specialist infrastructure.

• Emerging Technologies In Reactor Design

  Jillian Sheeran, Associate Director of Engineering at Snapdragon Chemistry, on how automation, feedback control, and machine learning are changing reactor design — with real-time monitoring that lets a process run continuously while the data comes to you.

• How Solid-State Characterization Shapes Drug Development

  Mark Benger, Site Director at Cambrex Edinburgh, on solid-state characterization as an insurance policy — front-loaded work that quietly determines whether a program survives the jump from kilos to tonnes.

• How Biocatalysts Address Process Development Issues

  Antje Gupta, General Manager of Cambrex IEP in Wiesbaden, on where biocatalysis outperforms conventional chemistry — matching enzyme classes to target conversions and production volumes to find the more scalable, more economical route.

• Optimizing Yield, Purity, And Scalability In A Cost-Effective Manner During Process Development

  Daniele Vigo, Assistant Director at Cambrex Milan, on getting yield, purity, and scalability right without burning through the budget.

• How AI And Automation Are Impacting Process Development

  David Ford, Senior Director of Chemistry at Snapdragon Chemistry, on the mountain of data behind every process development program — and why AI's real promise is surfacing the right piece of it at the moment a team needs to decide.

• Leveraging New Technologies To Optimize And Accelerate R&D

  Ingrid Ekman, Director of R&D at Cambrex Karlskoga, on why smoother tech transfer starts much earlier than most teams think — with systematic data and design of experiments that map a process's boundaries before it ever reaches commercial scale.

• Market Dynamics Related To The Development And Commercialization Of Peptides

  Matt Bio, CSO of Cambrex and President of Snapdragon Chemistry, on the capacity bottleneck behind peptide shortages — and why moving from solid-phase to liquid-phase synthesis unlocks reactors already sitting idle around the world.

• Approaching Process Validation During Tech Transfer To Commercial Manufacturing

  Matthew Schiesher, Head of R&D at Cambrex Charles City, on validating processes under the clock — and how running multiple sites in parallel shortens the path to launch when patients are waiting.

• Impactful Applications In Flow Chemistry And Radical Chemistry

  Miles Blackburn, Associate Director of Chemistry at Snapdragon Chemistry, on why the biggest payoff of flow and radical chemistry is speed — processes that scale fast enough to get intermediates and APIs delivered on a clinical timeline.

• Trends And Technologies Shaping The Future Of API Manufacturing

  Päivi Tolstoy, Manager of Process Development at Cambrex Karlskoga, on why sustainability is the trend to watch in API manufacturing — and why the real question is how few steps it takes to build a complex molecule.

• Liquid Phase Peptide Synthesis: Regulatory, Analytical, And QC Perspectives

  Discover how Liquid Phase Peptide Synthesis (LPPS) uses traditional reactors to create more efficient and sustainable peptide manufacturing. Learn about key analytical and quality control considerations.

• Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation

  Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.

• Removing The Headache: Outsourced Stability Storage And Testing Solutions

  Should you manage certain operations internally or partner with a trusted external provider? Watch experts discuss the benefits of outsourcing stability, storage, and testing.

• Innovative Technology For Developing, Scaling Peptide-Based Therapeutics

  Watch as experts walk through several technologies and case studies, focusing on liquid-phase peptide synthesis, crystallization, method development for impurity analysis, and more.

• Optimized Stability Storage

  A healthcare manufacturer facing space constraints and regulatory pressures outsourced their stability storage needs to another company, resulting in reduced costs and focus on core competencies.

• Implementing A Disaster Recovery Plan

  When facing a malfunction, having an effective disaster recovery plan can make the difference between a swift fix, and losing your samples and time.

• Strategic Space Management

  A pharmaceutical company facing storage space issues decided to outsource its reference samples to Q1 Scientific, a stability storage service provider, resulting in cost savings.

• Outsourcing Stability Storage: A Cost-Effective And Quality-Driven Approach

  Partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry by saving costs and resources, and ensuring product quality and compliance.

• Leveraging A Trusted Partner For Outsourcing Stability Storage

  Gain insight into the benefits of outsourcing stability storage compared to handling in-house. By outsourcing stability storage, eliminate the need for investing in and maintaining in-house stability chambers or cabinets.

• Costs And Risks Associated With In-House Stability Storage

  By performing stability storage in-house, you are taking on several risks. Find out how you can eliminate stability storage risks and save your resources and finances.

• Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing

  Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

• Continuous Manufacturing: An Evolving Technology For Drug Manufacturing

  Explore the exciting developments in continuous manufacturing and learn how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.

• Enabling Complexity: Drug Substance Manufacturing Via Continuous Flow

  As molecular complexity continues to increase, flow chemistry is becoming an essential enabling technology to facilitate the integration of complex synthetic methods into API production.

• Extractables And Leachables: Risk Management And Analytical Solutions

  Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

• How Life Science Is Reshaping Supply Chains In Response To COVID-19

  COVID-19 disruptions led companies to rethink global supply and outsourcing strategies. A survey of 117 biopharma leaders gauged how that experience is shaping attitudes toward resilience.

• Digital Transformation In Regulatory: Achieving Excellence Virtually

  As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

• Balancing Cost Efficiencies In The Drug Development Process

  Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.

• Assessing End-To-End Drug Development Partnerships

  As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs to maximize efficiencies. Examine the opportunities and challenges of end-to-end arrangements.

• Addressing Development And Manufacturing Upheaval

  Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future with uncertainty and disruption.

• Components Of An Effective Disinfectant Prequalification Strategy

  Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

• Demonstrating Control Over The Manufacturing Process: QbD Studies

  Understand the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

• Pinpoint Manufacturing Steps That Require Tighter Control

  With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.

• Route Development: Designing Synthesis For GMP Production

  The successful transition from initial synthesis of an API to a kilogram-scale route requires expert analysis and design, and a balance of economic, regulatory, and time constraints.

• Rapid Characterization Of Impurities

  Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

• Qualified Reference Standards: Setting The Standard For Product Quality

  Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

• Peptide Synthesis: Delivering Cost-Effective Strategies

  For peptide APIs, using a liquid phase peptide synthesis (LPPS) approach offers a cost-effective process for large-scale manufacture by eliminating the need for specialized equipment and excess raw materials.

• Crystallization Process Development: Peptide Crystallization

  Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.

• Overcoming Limitations To Achieve Uniform Dosing

  An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

• Selective Crystallization Of A Novel Polymorph

  Discover how applied rigorous characterization standards and expert knowledge of critical water activity enabled the isolation of a previously undiscovered and uncharacterized polymorph.

• Mitigating Hidden Risks: Extractables And Leachables

  Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

• Method Optimization: Assay Development Following Compendial Methods

  There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.

• Method Development: Managing A Diverse Range Of APIs

  See how the team developed analytical methods to support pre-clinical and future GMP production under tight timelines.

• Full IND Program: Exceeding Requirements For Submission

  Follow a compound through a full cycle of IND development, from modifications to the synthetic route to formulation development and API manufacturing.

• Crystallization Process Dev: Ramping Up Bench-Scale Control

  Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

• Painkiller And Sedative Demands: Effects On Bupivacaine HCI Supply

  As global authorities work to fill gaps, drug manufacturers and CDMOs have become critical in the efforts to stabilize the supply of Bupivacaine HCl and other essential drugs.