07.18.24 -- Emerging Biotechs Judge CDMOs More Harshly

Balancing stakeholder expectations and opinions, and sometimes mitigating disagreements, during a change can prove more daunting than the change itself.

Vincent Kosewski, VP at Kala Pharmaceuticals, believes there’s a gap when it comes to biotechs performing the necessary gap analysis before initiating outsourcing activities.

Medtech OEMs, contract manufacturers, and other partners involved in the device life cycle are increasingly realizing additional benefits by making sustainability a group exercise.

Controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of breakage during lyophilization and ensure product quality.

As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.

ICH Q14 provides comprehensive guidance on analytical procedure development, offering a framework for ensuring the development of regulatorily compliant analytical procedures.

Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational benefits that stem from fostering a collaborative environment.

Selecting the right cell line is crucial in upstream development. Delve into key considerations that manufacturers must keep in mind to achieve high-quality and high-yield mAbs.

With a growing interest in developing new and improved bioconjugate drugs, explore an “innovation through collaboration” approach that can facilitate access to next-generation conjugation technologies.

Advancements in lyophilization technology and research have helped overcome inherent challenges and ensure the safety and efficacy of lyophilized pharmaceuticals.

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that utilized cell line engineering.

Isolators provide a controlled and sterile environment during manufacturing. A CDMO that prioritizes quality, sterility, and compliance can help you deliver the highest level of quality and sterility.

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

The BD UltraSafe Plus passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.

Our DPS offering delivers a holistic approach to DP development that anticipates and prevents problems early and ensures the result is a product that is fit for purpose.

Simulations enable faster and smarter downstream process development. Learn how mechanistic chromatography modeling takes you in silico.

Catalent's local team in Japan provides comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, and local and global distribution.

Our multi-product manufacturing facilities feature state-of-the-art equipment for animal cell-derived viral and microbial products for your clinical trials in phase 1-2 and in accordance with cGMP guidelines.