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.

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

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.

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.

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

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

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.

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.

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

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.

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.

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

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.

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

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.

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.

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

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.

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.

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

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

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.

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>.

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

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

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.

A biotech with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase II / III trials.

A pharma company sought a CMO partner with commercial manufacturing capabilities and expertise as well as exemplary quality systems to find a cost-effective process to produce the API for a new drug.

Dan Bowles will discuss Cambrex’s small-volume commercial API manufacturing capabilities at its High Point, North Carolina, facility.

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.

Learn how we balance discovery and development as an asset scales, and how the One Cambrex model keeps the original process scientists attached to a molecule from first kilos through NDA.

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.

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.

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.

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.

Insights into the validation expertise behind process characterization and how deep problem-solving can turn a process into one robust enough to carry a drug to market.

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.

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.

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.

Anmaris Torres, Process Engineering Team Leader, on why a process transfer starts with a conversation across departments to figure out how to cut cycle time before commercial production begins.

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

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.