Drug Development

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Matt Shaffer, manager, formulation development, Bend Research, a division of Capsugel’s Dosage Form Solutions business, and Martin Koeberle, PhD, head of analytical development and stability testing, Hermes Pharma, spoke to Pharmaceutical Technology about the different approaches used in taste-masking and the challenges involved.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

More complex drug candidates require more specialized and selective chemistry.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions shares insights on trends shaping the evolving solid dosage manufacturing landscape, including advances in excipients and the impact on formulation development and manufacturing processes.

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.