Category: Biologics

Th increasing demand for biologics has led to an increasing need for production capacity, which is characterized by high quality standards. Although, it is a challenging field, outsourcing has emerged as a promising segment, especially for drug fill finish manufacturing and aseptic fill finish operations. Despite being one of the crucial steps of all the

Over the years, the incidence and prevalence of chronic diseases, have increased significantly. Presently, the recommended treatment options for such clinical conditions are mostly biologics, which need to be administered via parenteral routes to ensure maximum therapeutic benefit. Given the inherent requirement for frequent medication, patients suffering from such long-lasting clinical conditions generally end up

The gradual shift of healthcare industry towards the development of biologics is a well-known fact. Owing to this shift, there are over 1,000 cell and gene therapies which are being developed for the treatment of various disorders, majority of them being oncological disorders, cardiovascular disorders and neurological disorders.  Additionally, over the last decade, multiple immunotherapies

A lot has happened. And that too in a short span of time. A few weeks ago, everyone outside China was worried about the quarantined cruise ships. No one at that stage would have thought that, just in a few days, the virus may be knocking at the doorsteps. Now there is fear and it

So, another round of the World ADC (Antibody Drug Conjugates) just concluded. With a stellar line up that included Alain Beck from Pierre Fabre, Thorsten Sperber from Immunomedics, Nicholas Choong form Seattle Genetics, Rakesh Dixit from BioNavigen, Trevor Hallam from Sutro Bio and many other eminent personalities, the event did live up to its expectations.

According to a recent CDMO survey, about 54% respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development projects. Specifically, fill / finish is the final step in the production process and is considered among the most crucial stages of drug product manufacturing. Biologic drug products require special procedures

Given their high target specificity and limited toxicity compared to small molecule drugs, biotherapeutics have revolutionized treatment paradigms across a myriad of clinical conditions, including metabolic disorders, cancers, neurological disorders and autoimmune disorders. In fact, the extent of growth of such therapies can be gauged from the fact that more than 300 biopharmaceuticals have been

It is estimated that, by 2025, around 15% of the world’s population will have had their genomes sequenced, resulting in the generation of several zettabytes of data. However, currently, there are not many reliable and secure data management resources that offer secure storage, seamless exchange of information, and a reliable transaction platform, for large volumes

Antibody drug conjugates (ADCs) are one of the most popular classes of targeted therapeutic agents and have captured the attention of both large and small pharmaceutical companies, and academic / research institutions across the world. Owing to the fact that these novel conjugates act as cytoxic drugs and HPAPI molecules, their manufacturing requires elaborate technical

Owing to several beneficial features, such as high specificity, and a favorable safety profile, antibody (Ab) discovery based pharmacological interventions, with 79 molecules approved till date and over 200 molecules in the preclinical / discovery stages, presently represent the largest class of biologics. The antibody discovery market involves a long, arduous and cost intensive process.

Although cancer therapeutics continue to be one of the most active areas in terms of drug development, there is still a significant unmet need in this domain. Conventional cancer treatments, such as chemotherapy, surgery and radiation therapy, have demonstrated very limited efficacy in late-stage cancers. Amidst the current initiatives to develop more targeted anti-cancer therapies,

Biologics constitute a majority of the top selling drugs and represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, the share of biologics in the overall pharmaceutical contract manufacturing market has increased from 16% in 2006 to over 25% in 2017.  Having reported over 70% increase in revenues over the

Over the last few decades, various Viral Vectors and non-viral vectors have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells. Currently, the most popular viral vectors, on the basis of their use in active clinical trials, are those based on AAV, adenovirus, lentivirus

Spray drying, which is already established in the food and chemical sector, is also considered to be a rapid, cost-effective, and scalable process for the production of dry powder formulations of pharmacological material. Owing to characteristics, such as reproducibility and its continuous mode of operation, the technique has become very popular in the pharmaceutical contract

Amidst the current initiatives to develop more targeted anti-cancer therapies, immunotherapy has emerged as a highly potent option to eradicate tumor cells with minimal side effects. It is based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. It encompasses several treatment approaches, such as monoclonal

Oral peptides and protein-based therapeutics have been in use for more than three decades since the approval of recombinant human insulin, the first protein therapy, in 1982. Earlier, most biologic drugs were the subcutaneous biologics. However, over time, advances in delivery formulations have enabled the development of oral peptides / proteins. Owing to numerous compelling