Blog 2018-01-03T03:29:05+00:00
1409, 2017

BSL-3 Biologic Development

By | September 14th, 2017|Categories: Manufacturing|Tags: , , , , , |0 Comments

Advances in Biological Safety Level 3 technology offer advantages for agile biologic developers. by Raymond E Peck, CEO of VxP Biologics Many types of biologics include live populations of organisms, some of which may be highly infectious in active form. Vaccines, in particular, often contain deadly bacteria and viruses in live but attenuated forms. The storage and processing of these dangerous organisms requires specialized laboratory facilities, where infectious agents can be handled securely, in accordance with the risk levels they pose. In fact, the US Centers for Disease Control (CDC), the Department of Agriculture (USDA) and the National Institutes of Health (NIH) all provide detailed parameters for the design and management of facilities where infectious agents will be stored and handled. These guidelines specify safety levels ranging from biosafety 1 to 4 (BSL-1 to BSL-4), depending on the degree and nature of the risks posed by a given biological agent. A facility with BSL-3 biocontainment precautions is both necessary and sufficient for the containment of “indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure,” according to the CDC’s guidebook Biosafety in Microbiological and Biomedical Laboratories (BMBL). As the following analysis of the design of a typical BSL-3 lab will explain, these precautions are necessary for a wide range of reasons. A BSL-3 facility is designed to ensure the safety of workers and other community members. A BSL-3 facility is designed to ensure the safety of workers and other community members. The top priority for any BSL-3 facility is to protect lab workers and the public from pathogens and toxins classified as Class III by the CDC. These facilities also also used to handle pathogens [...]

309, 2017

Clinical Stage Products

By | September 3rd, 2017|Categories: Research & Development|Tags: , , , , , , , , |0 Comments

Emerging technologies offer exciting opportunities for the development of novel therapies. by Susan Thompson, Technical Director at VxP Biologics Although commercial sales are certainly a desirable target for pharmaceutical development, they’re far from the only reason to invest in new products. In a number of fields, pharma developers are partnering with contract manufacturing organizations (CMOs) to develop products designed specifically for clinical-stage trials. Clinical stage products can become profitable intellectual property, even as they advance the pharmaceutical field and provide new opportunities for innovation. Here are three of today’s most promising product categories for clinical stage pharmaceutical development. Monoclonal antibodies are one class o viable clinical-stage products. Emerging technologies offer exciting opportunities for the development of novel therapies. Also known as mAbs or moAbs, monoclonal antibodies are generated in clones of a cell, often from a human or rodent. They bind specifically to epitopes of the same antibody from which they’re generated. This property enables them to bind to specific antigens in a patient’s body, inducing or reducing an autoimmune response in target cells. For example, mAbs are used in a wide range of cancer treatments, binding to antigens present in cancerous cells, and triggering the immune system to attack those cells. In a reverse scenario, mAbs are used to treat autoimmune diseases like rheumatoid arthritis, ulcerative colitis and Crohn’s disease, by binding to receptor sites that suppress autoimmune responses. In a similar way, mAbs can be used to prevent the rejection of transplanted organs. Beyond this, mAbs can also be engineered to deliver a specific cytokine, radioisotope or toxin to specific cells, or even to activate specific receptors on a cell membrane. The range of mAbs used in clinical research and therapy [...]

1108, 2017

Biologics Process Development

By | August 11th, 2017|Categories: Manufacturing|Tags: , , , |0 Comments

As the biologics market expands, developers need support from expert contractors. by Raymond E Peck, CEO of VxP Biologics A growing number of pharmaceutical development companies are partnering with contract manufacturing organizations (CMOs) to meet the global demand for biologics. This investment comes with good reason: as of 2016, the global biopharmaceutical market was valued at $192 billion, up from $176 billion in 2015, witnessing a staggering compound annual growth rate (CAGR) of 8.6 percent. Big pharma companies have expressed intense interest in the biologics market since 2008 or earlier. Major players such as Wyeth, Pfizer and Bristol-Meyers Squibb have all acquired smaller biotech firms and purchased large biomanufacturing facilities, as well as investing in enhanced capabilities for existing ones. As blockbuster biologic patents worth billions expire every year, the market remains ripe for firms able to move quickly and capitalize on their intellectual property (IP). In this highly competitive landscape, expert manufacturing capabilities are more crucial than ever. Few pharma developers possess these the in-house expertise necessary to ensure efficient manufacturing processes that produce minimal waste. However, some contract manufacturers offer exactly that level of expertise, providing significant advantages over in-house capacities. Here are some of the most critical reasons why biologic developers are partnering with CMOs. Contract manufacturing organizations offer strong expertise in biologics processes. CMOs can proactively manage biologics processes and help mitigate risk. Not all CMOs provide equal technical competency. Any developer planning to partner with a CMO should perform due diligence, auditing carefully for quality, consistency, cost-effectiveness and related factors. However, once a developer has found a trustworthy contractor, the benefits of that partnership can far exceed the capabilities of any in-house facility. Contract manufacturers typically offer equipment, [...]

1806, 2017

New Investments and Approvals Spur the Development of Biologics

By | June 18th, 2017|Categories: Manufacturing, Research & Development|Tags: , , , , , |0 Comments

Although still expensive to develop and produce, large molecules are rapidly taking over. by Susan Thompson, Technical Director at VxP Biologics For most of the previous century, much of pharmaceutical research focused on the development of small-molecule “blockbuster” drugs, which treated a wide variety of diseases for a great number of patients, and could thus be patented and turned to tremendous profit. Over the past few years, though, the days of the small molecule have been quietly drawing to a close. As effective cures become more difficult to find (particularly for diseases like cancer and immunological disorders) a growing number of pharma firms are turning to biological research, adapting molecules and processes found in living organisms to therapeutic uses. This requires the use of biologics: large, complex molecules manufactured inside living cells. Despite some promising success stories, biologics remain highly expensive to develop and manufacture. They’re also almost prohibitively expensive on the patient’s end of the bargain, frequently costing $45,000 or more for a single round of treatment. Even so, new regulatory approvals, continue to draw increasing investment to the biologic sector. Biologics provide highly targeted solutions to specific health problems. A new selection of biologics are coming on the market right now. Although biologics appear to be a twenty-first century phenomenon, their earliest successes date back more than 30 years. In 1986, biologics known as monoclonal antibodies (mAbs) first appeared on the market, effectively treating certain types of cancer that responded poorly to conventional therapies. Since then, mAbs have become common treatments for rheumatoid arthritis, prosiasis, and other autoimmune disorders. Unlike traditional small-molecule drugs, biologics such as mAbs are created using proteins from human or animal cells, often grown inside bacteria, or [...]

1606, 2017

Development of Biologics – Monoclonal Antibodies

By | June 16th, 2017|Categories: Research & Development|Tags: , , , , , |0 Comments

Monoclonal antibody approval success rates vary widely, but are on the increase overall. by Raymond E Peck, CEO of VxP Biologics The human monoclonal antibody (mAb) sector has witnessed tremendous growth since its inception in the early 1980s. Despite a rocky start, new technologies in molecule generation spurred rapid development throughout the 1990s; and in 2002, the US Food and Drug Administration (FDA) approved adalimumab as the first human mAb for clinical use. An ever-growing list of other mAbs have followed since then. Today, human mAbs represent the most rapidly growing category of clinically studied mAb therapeutics. In addition, many mAbs are “chimeric,” combining DNA sequences derived from humans and rodents. Still others are derived by recombining fragments of human DNA in bacteriophage viruses, and selecting the best expressions. Each approach offers its own advantages and disadvantages. And as mAbs grow in popularity for treating a widening range of disorders, success rates continue to vary among each approach, even as they increase on the whole. Here is a quick survey of the state of the mAb sector. Human mAbs target a wide range of sites for a variety of therapeutic purposes. Some mAbs are derived from rodents, or expressed within bacteriophage viruses. The vast majority of human mAbs are developed for the treatment of cancer, and of disorders of the immune system. For antineoplastic mAbs, the success rate is a mere 15 percent in clinical trials. Among these, the most common target is the epidermal growth factor receptor (EGFR) protein, which impacts a cell’s growth and mitosis. EGFR has been a popular target for researchers since the 1980s, and it remains one of the most widely studied receptors in anticancer research. Among immunomodulatory [...]

606, 2017

Sterile Injectables for Clinical Trials

By | June 6th, 2017|Categories: Manufacturing, Research & Development|Tags: , , , |0 Comments

Growth continues, but logistical and regulatory hurdles limit worldwide supplies. by Susan Thompson, Technical Director at VxP Biologics The global market for sterile injectables continues to expand at an impressive rate. In 2015, this market was valued at $299.7 billion; and its compound annual growth rate (CAGR) is projected at 6.9 percent, at least through the year 2024. Even so, the processes of developing and manufacturing sterile injectables remain costly and complicated. Because the majority of injectables are toxic in their natural forms, careful handling and packaging are crucial throughout the clinical trial phase. The US Food and Drug Administration (FDA) also tightly regulates equipment and facilities, mandating good laboratory practices (GLP) and good manufacturing practices (GMP) around the manufacture, storage, packaging and distribution of sterile injectables. The high costs associated with these stringent regulations have created a limited supply that often fails to meet rising worldwide demand. Contract manufacturing organizations (CMOs) are taking up at least some of the the slack. In fact, many of these organizations have become close partners (or even subsidiaries) of the pharmaceutical development firms they support. Here are three overarching trends that define the current sterile injectables market, particularly in terms of clinical trials. Regulatory and safety hurdles create shortfalls in the supply of sterile injectables. Within the sterile injectables market, demand remains highest in the area of biologics. An increasing number of CMOs are investing heavily in this area, and those investments will continue to increase as vaccines, biologics and biosimilars offer an expanding range of opportunities for profit and market share. Particularly intense investment has focused on the development and clinical trialing of monoclonal antibodies and conjugates of antibody drugs, which have proven effective at treating some [...]

405, 2017

Five Crucial Areas of Concern in Any GLP Lyophilization Process

By | May 4th, 2017|Categories: Parenteral & Lyophilized Clinical Trial Materials|Tags: , , , , |0 Comments

Although lyophilization (freeze-drying) is a costly, time-consuming process, it offers a number of major advantages over simpler dosage forms. by Raymond E Peck, CEO of VxP Biologics Tablets and capsules can create problems for patients with nausea or difficulty swallowing; syringes can carry risk of infection; and even certain drugs administered from vials can take excessive time to be broken down and absorbed into the body. By lyophilizing pharmaceutical products such as vaccines, peptides and liposomes, it’s possible to prevent a significant amount of chemical degradation. A well-designed process can also provide long-term stability in storage, maximize biological activity, and produce a rapidly dissolving formulation that reliably retains the characteristics of the original dosage form. Still, an effective lyophilization procedure requires precise alignment of several factors. Here are five major areas of concern regarding good laboratory practice (GLP) for any lyophilization method. Ideal formulation conditions are a core concern in any GLP lyophilization process. Ideal formulation conditions are a core concern in any GLP lyophilization process. Throughout the freezing, primary drying and secondary drying stages of the lyophilization process, risks of damage and destabilization abound. As the formulation cools, pure crystalline ice forms within it. This creates a freeze concentration of the non-frozen liquid, which transforms into a more viscous state, and does not crystallize. The goal is for this concentrated, viscous solution to solidify into a phase that may be amorphous, crystalline, or amorphous-crystalline. But a rapid nucleation and growth rate can significantly impact the size and number of ice crystals that form. If supercooling takes place too rapidly, an unexpectedly large number of smaller ice crystals may develop. When proteins come into contact with this large ice-water interface, they can become [...]