BlogHeader.png

White Paper: Optimizing HPAPI Manufacturing Performance

Outsourcing highly potent active pharmaceutical ingredient (HPAPI) development and manufacturing is reaching an all-time high thanks to an increased demand of highly-targeted new drugs with greater efficacy at lower doses and the price of investment to handle internally. Several factors will dictate the performance of a contract development and manufacturing organization (CDMO) when handling HPAPIs. It is not merely a question of having the physical assets for high containment; outsourcing of a specialized and potentially challenging piece of the supply chain requires partnership and collaboration between the CDMO and sponsor. Any relationship is reliant upon transparency, team cohesion, and a level of experience that ensures a collaborative understanding with effective communication. Ultimately, success relies upon the equipment, experience, and a right-first-time ethos. Consider the factors discussed in this white paper when evaluating a potential CDMO partner.

Topics: Thought Leadership Resource Center HPAPI API HPAPI Manufacturing

Formulating for Orphan Indication Drug Products

According to the US Orphan Drug Act of 1983, a rare disease is defined as a condition that affects fewer than 200,000 people. The term orphan disease originated from pharmaceutical companies not having the resources to design and scale-up formulations to treat these diseases due to the lack of financial support for such highly specialized programs. The need for financial backing resulted in The Orphan Drug Act of 1983 that gave companies a means to develop treatments for rare diseases (NIH, 2017).

Rare diseases are caused by various reasons— most notably by genetics. However, the National Institutes of Health (NIH) states, “many rare diseases, including infections, some rare cancers, and some autoimmune diseases, are not inherited. While researchers are learning more each year, the exact cause of many rare diseases is still unknown” (NIH, 2017). Almost half of those affected by rare diseases are children (Global Genes, 2018).

Topics: Thought Leadership Drug Product Formulations

White Paper: A Practical Approach to Extractables and Leachables on Manufacturing Surfaces

The study of extractables and leachables is among the fastest-evolving disciplines in the pharmaceutical industry. Until recently, the primary focus of these studies has been components in direct contact with the drug product for extended periods, such as the primary packaging, or those that contact the formulation during administration, known as in-use componentry. However, the components used in manufacturing are of increasing interest as sources of potential leachables. Many components are single-use systems (SUS), polymeric in construction, and pre-treated prior to use. Each of these factors increase the potential for leachable compounds. In order to evaluate materials for potential leachable compounds, one must leverage a scientifically rigorous study design against the specific potential for drug product and packaging/surface interaction. 

Topics: Thought Leadership Resource Center Extractables & Leachables Drug Product Extractables Studies Analytical Evaluation Threshold

Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to a drug or biological product (drug) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation, or orphan status. For a drug to qualify for orphan designation, both the drug and the disease or condition must meet certain criteria specified in the ODA and US Food and Drug Administration’s (FDA) implementing regulations per 21 CFR Part 316. The FDA Office of Orphan Products Development (OOPD) evaluates the scientific and clinical data submission from sponsors to identify and designate products as promising for rare diseases or conditions.

Topics: Thought Leadership Regulatory Compliance Drug Product

Considerations for Abuse-Deterrent Category One Syringeability Studies

The use of opioid medications for pain management continues to increase, generating an inevitable association with abuse and addiction. Government officials and pharmaceutical professionals alike are in need of risk mitigation approaches (Katz, 2008). The Abuse Deterrent Access Act of 2018 requires Medicare and Medicaid to report to Congress the availability of abuse-deterrent opioid pain treatments. The bill is meant to decrease the amount of barriers for their enrollees (Carter, 2018).

The U.S. Department of Health and Human Services (HHS) has estimated that in 2016, the most recent year for which complete data are available, over 42,249 Americans died from opioid overdoses, the most of any year on record. More than 2.1 million Americans had an opioid use disorder (addiction) in 2016, with economic costs from the epidemic estimated to be as high as $504 billion dollars (Johns Hopkins University Bloomberg School of Public Health, 2018).” Pharmaceutical companies have responded to this need through more stringent abuse-deterrent formulations and studies.

Topics: Thought Leadership Abuse-Deterrence

Beyond the Bench: A Century of Experience

The second edition of the Beyond the Bench series features three of Alcami’s longest tenured employees. Meg, Karen, and Sally have worked at Alcami and its legacy companies over a century, collectively. These women share in common not only a long history with the company, but they are all also great at sharing their knowledge. Please meet Meg, Karen, and Sally. 

Alcami applauds your loyalty and dedication. You are all valued, expert contributors at your sites! Please introduce yourselves and paint a picture of your start with the company .

Topics: Thought Leadership Alcami Voices

Elevate Product Stewardship and Exceed Your Sustainability Goals

At Alcami, the health and safety of our workers is not taken lightly. Rooted in the foundation of The Alcami Way, safety comes first and is one of our non-negotiables. As a trusted partner and supplier, we can help you achieve your product stewardship and sustainability goals by providing a safe and healthy working environment for our employees.

The globalization of the pharmaceutical industry has led to supply chains that can be extremely complex and difficult to manage. In some cases, the health and safety practices can be vastly different than the current expectations from the public and shareholders. As sustainability intelligence increases, transformative operational strategies are needed to optimize your supply chains and meet your goals.

Topics: Thought Leadership EH&S

Case Study: Orphan Drug Product

According to the Food and Drug Administration and the Orphan Drug Designation program,  orphan status is applicable to drugs and biologics which are defined as “those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.” Due to the high costs and low demands of the drug product, it is important to efficiently use your API supply during the formulation process. This case study presents how Alcami successfully helped a client overcome an API supply shortage using Quality by Design studies to successfully formulate an orphan drug product. 

Topics: Thought Leadership Resource Center Oral Solid Dose API Drug Product Formulations

Understanding Pharmaceutical Packaging

For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are critical to the success of a product. The best formulated product in the world can fail if it is contained in an inappropriate package. So how does one decide which packaging to use for a product?

First and foremost, the package has to protect the product from damage or degradation. Different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered products may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. Alcami works with clients to customize the best package configuration for product protection.

Topics: Thought Leadership Serialization Oral Solid Dose Packaging Pharmaceutical Packaging

Panel Discussion: Oral Solid Dosage Manufacturing Process 

Alcami recently contributed to Pharma Horizon's first Panel Discussion of 2018, dedicated to the Oral Solid Dosage (OSD) Manufacturing Process. 

The topics discussed include main challenges that manufactures of OSD forms have to face, such as quality, safety and productivity, as well as technical advancements, production management, operational excellence aspects, tech transfer, and packaging operations.

Topics: Thought Leadership Manufacturing Editorials Oral Solid Dose