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Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances

Controlled drug substances are scheduled based on medical use in treatment, potential for abuse, and dependence caused if abused— the lower the control schedule the more potential for abuse. The process to obtain approval from the Drug Enforcement Administration (DEA) for Schedule I-V controlled substances and List I chemicals licensing involves intricacy and a detailed timeline of approvals. This article will discuss the background of controlled substance applications and how to successfully work with the DEA.

Topics: Thought Leadership Regulatory Compliance Drug Product Controlled Substances API

Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH recently received U.S. Food and Drug Administration (FDA) approval of moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). MDGH utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical approval deadlines.

Topics: Company News Analytical Development Analytical Testing Development Drug Product

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 Orphan Drugs

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

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 Orphan Drugs

The Role of Full Time Equivalent (FTE) Programs

An FTE agreement is considered a comprehensive analytical service that allows pharmaceutical and biotech companies flexibility, freedom, and consistent control of outsourced laboratory needs.

Drug developers with an abundance of overflow lab testing or limited lab space and staffing are ideal candidates for what Alcami calls an Extended Workbench program. Additional support may also be critical if the US Food and Drug Administration (FDA) approves the acceleration of your drug product. The chart below is a summary of the FDA’s drug development descriptions for when a product has significant implication on a patients’ welfare (FDA, 2018).

Topics: Analytical Development Analytical Testing Development Drug Product

Alcami’s Extended Workbench Supports Commercial Supply of Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)

Durham, NC (USA) – June 13, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announced the expanded deployment of its Extended Workbench laboratory services program to support the ongoing manufacturing and development of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension). ZILRETTA is the first U.S. Food and Drug Administration (FDA) approved product from Flexion Therapeutics, Inc., a Massachusetts-based biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA). Flexion utilized Alcami’s Extended Workbench to support ZILRETTA from Phase 2 clinical trials through commercial launch and is using the program for the release and stability testing of commercial batches.

Topics: Company News Analytical Development Analytical Testing Development Drug Product

Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain Security Act.  Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning no later than November 27, 2017.  Ultimately, the FDA recognized the massive undertaking of such a requirement and extended the deadline to November 26, 2018.

Alcami began implementing serialization in 2015 to achieve the aggressive timelines and develop the necessary documentation needed to meet compliance.

This case study shows how Alcami has successfully transferred clients into the new serialization program.

Topics: Drug Product Resource Center Serialization Regulatory Compliance

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

Additional Equipment and Capacity for Drug Product Manufacturing in Wilmington, NC

Wilmington, NC –December 21, 2015 – AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, today announces additional capabilities and capacity for oral solid manufacturing in its Wilmington, NC facility. These investments have been driven by the significant growth in our drug product portfolio, particularly for orphan drugs and rare disease therapies.

Topics: Company News Drug Product