Manufacturing, Combination Drugs

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, talks about the differences in designing E&L testing for combination products vs. conventional pharmaceuticals.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

Under a new pact, Genentech and PeptiDream will collaborate to discover and develop novel peptide-radioisotope drug conjugates.

API supplier Olon has started construction of a new manufacturing facility in Milan, Italy, which will be dedicated to production of cytotoxic payloads and linkers for ADCs.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

Drug makers continue to explore innovative ways to develop antibody-drug conjugates based on their unique potential to neutralize cancer cells.

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.

Communication and taking the time to develop the process are key to successful transfer and scale up of biologics

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

Scale-up of complex, innovative products requires commercialization models that are sustainable.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

Researchers discovered more than 300 antibodies that reacted with the Ebola virus’s surface glycoprotein and could be used to neutralize many strains of the virus.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.

The agency gives an update on the regulation of combination medical products.

Althea is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.