API Synthesis and Manufacturing, Large Molecule

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Hazardous reagents can simplify processes and provide higher yields and purities.

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

A strong API market is expected in 2016 despite fewer new drug approvals.

Umicore is one of the largest producers of platinum APIs for anti-cancer treatment. We pride ourselves in having decades of experience in platinum group metals chemistry and high potency APIs.

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.)

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.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

The International Conference on Harmonization finalizes Q&A document on APIs.

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

CMO executives share their opinions on where outsourcing is going and what is driving market change.

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

Pfizer advances its pipeline of antibody-based therapies using a host cell line that combines engineered glycosylation technology and enhanced gene-expression.

Because peptoids are relatively easy to synthesize, have tremendous sequence diversity, and are more proteolytically stable than peptides and proteins, they have significant potential for use as APIs, drug-delivery agents, and in numerous biomedical applications.

Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.

As 2012 comes to a close, Pfizer leads among Big Pharma companies for FDA approvals of new molecular entities and biologics.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Approaches in using small-molecule and peptide synthesis offer promise in widening the scope of drug candidates.

Biologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.

Stuart Needleman, president of active-ingredient development and manufacturing at Aptuit, discusses industry trends and challenges.

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing.