Highly Potent Drugs

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

In addition to ADCs, other types of highly potent biologics require specialized manufacturing skills.

The company will expand its micronization abilities for highly potent drug compounds through this investment.

Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.

The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

The ChargePoint Single Use Passive and ChargeBag create a single-use system for contained and sterile transfer of pharmaceutical powders between process steps or facilities.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.

ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

Demand for highly potent APIs continues to rise.

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

Determining how much containment is needed for API handling requires evaluation of multiple factors.

Bosch Packaging Technology’s GKF 720 capsule filling machine for small batches of hard capsules uses a fully automated, washable containment process.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.

Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.

The technology, known as Verifi, is available with the ChargePoint’s range of valves that ensure safe and contamination-free handling of API and other formulation ingredients.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

Cambrex invests in development and laboratory facilities and adds staff.

Hovione has installed a new MG2 Tekna Precision Capsule filler at its Portugal site.

CDMOs have established strategies for handling new chemical entities with unknown biological activity.